Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism

A Single-Center Study Comparing the Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism Over 1 Month of Daily Wear.

The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.

Study Overview

• Status: Completed
• Conditions: Astigmatism
• Intervention / Treatment: Device: comfilcon A; Device: lotrafilcon B

Detailed Description

Single masked, open label, randomized, bilateral, crossover study design comparing comfilcon A against lotrafilcon B lenses over 1 month of daily wear for each study lens. Each subject will be randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Valencia, Spain
    • Optometry Research Group (GIO) - Optics Department, University of Valencia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

A person is eligible for inclusion in the study if he/she:

• Is between 18 and 40 years of age (inclusive)
• Has had a self-reported visual exam in the last two years
• Is an adapted soft toric contact lens wearer
• Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive)
• Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes.
• Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
• Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
• Has clear corneas and no active ocular disease
• Has read, understood and signed the information consent letter.
• Patient contact lens refraction should fit within the available parameters of the study lenses.
• Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
• Is willing to comply with the visit schedule

Exclusion Criteria:

A person will be excluded from the study if he/she:

• Has a contact lens prescription outside the range of the available parameters of the study lenses.
• Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye.
• Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
• Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
• Presence of clinically significant (grade 2-4) anterior segment abnormalities
• Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.

• Slit lamp findings that would contraindicate contact lens wear such as:

  • Pathological dry eye or associated findings
  • Pterygium, pinguecula, or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from of the limbus
  • Giant papillary conjunctivitis (GCP) worse than grade 1
  • Anterior uveitis or iritis (past or present)
  • Seborrheic eczema, Seborrheic conjunctivitis
  • History of corneal ulcers or fungal infections
  • Poor personal hygiene
• Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
• Has aphakia, keratoconus or a highly irregular cornea.
• Has Presbyopia or has dependence on spectacles for near work over the contact lenses.
• Has undergone corneal refractive surgery.
• Is participating in any other type of eye related clinical or research study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: comfilcon A; Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.	Device: comfilcon A; test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B); Other Names: Biofinity Toric; Device: lotrafilcon B; test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B); Other Names: Air Optix
ACTIVE_COMPARATOR: lotrafilcon B; Each subject randomized to wear the test lens (comfilcon A) or the control lens (lotrafilcon B) for one month of daily wear before repeating the schedule for the second pair without a washout period.	Device: comfilcon A; test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B); Other Names: Biofinity Toric; Device: lotrafilcon B; test lens Pair(comfilcon A) or the control lens Pair(lotrafilcon B); Other Names: Air Optix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily and Comfortable Wearing Time	Participant rating of lens Daily and Comfortable Wearing Time. Collected at baseline for all habitual lenses. (The hours of average comfortable wearing time and average daily wearing time.)	Baseline
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction	Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at baseline for all habitual lenses. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)	Baseline
Vision Quality Insertion, During Day, End Day	Participant rating of vision quality on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)	Baseline
Vision Stability Insertion, During Day, End Day	Participant rating of vision stability on insertion, during the day, end of day. Collected at baseline for all habitual lenses. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)	Baseline
Overall Sensation of Moistness	Participant rating for overall sensation of moistness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)	Baseline
Overall Sensation of Smoothness	Participant rating for overall sensation of smoothness. Collected at baseline for all habitual lenses. (5-point Likert Scale; Excellent, Good, Average, Below Average)	Baseline
Comfort Satisfaction	Participant rating for comfort satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	Baseline
Dryness Satisfaction	Participant rating for dryness satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	Baseline
Handling Satisfaction	Participant rating for handling satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	Baseline
Lens Fit Satisfaction	Participant rating for lens fit satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	Baseline
Vision Satisfaction	Participant rating for vision satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	Baseline
Overall Satisfaction	Participant rating for overall satisfaction. Collected at baseline for all habitual lenses. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	Baseline
Comfort Upon Contact Lens Insertion	Participant rating of comfort upon insertion. Collected at dispense for each lens. (0-10; 10=Can't Feel)	Dispense
Vision Satisfaction Upon Contact Lens Insertion	Participant rating of vision satisfaction upon insertion. Collected at dispense for each lens. (0-10; 10= Very Satisfied)	Dispense
Vision Quality With Contact Lens Prescription	Participant rating of Vision Quality with contact lens prescription. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)	Dispense
Vision Stability Upon Contact Lens Insertion	Participant rating of vision stability on insertion. Collected at dispense for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)	Dispense
Visual Acuity logMAR	Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at dispense for each lens. logMAR (VA).	Dispense
Centration	Assessment of Lens Fit Performance for centration. Collected at dispense for each lens. (Biomicroscopy; centered or slightly decentered)	Dispense
Corneal Coverage	Assessment of Lens Fit Performance for corneal coverage. Collected at dispense for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)	Dispense
Post Blink Movement	Assessment of Lens Fit Performance for post blink movement. Collected at dispense for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)	Dispense
Lens Orientation Primary Gaze	Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Collected at dispense for each lens. (Degree of mislocation relative to lens axis mark.)	Dispense
Lens Marking Visibility	Assessment of Lens Fit Performance for lens marking visibility. Collected at dispense for each lens. (1-3, 1=excellent, 2=average, 3=poor)	Dispense
Lens Stability on Blink	Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at dispense for each lens. (No rotation and 5-10 degrees rotation from axis location mark)	Dispense
Lens Stability 5-10 Min	Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at dispense for each lens. (Varied less than 5 degrees from lens marking location between 5-10 min)	Dispense
Lens Overall Stability	Assessment of Lens Fit Performance for overall lens stability. Collected at dispense for each lens. (Excellent or Good)	Dispense
Rotational Recovery 30/45 Deg	Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at dispense for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)	Dispense
Overall Fit Acceptance	Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at dispense for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)	Dispense
Daily and Comfortable Wearing Time	Participant rating of lens Daily and Comfortable Wearing Time. Collected at 2 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)	2 weeks
Daily and Comfortable Wearing Time	Participant rating of lens Daily and Comfortable Wearing Time. Collected at 4 weeks wear for each lens. (The hours of average comfortable wearing time and average daily wearing time.)	4 weeks
Participants Use of Rewetting Drops	Proportion of subjects using rewetting drops. Collected at 2 weeks for each lens. (Yes, No)	2 Weeks
Participants Use of Rewetting Drops	Proportion of subjects using rewetting drops. Collected at 4 weeks for each lens. (Yes, No)	4 Weeks
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction	Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 2 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)	2 weeks
Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction	Participant rating of lens Comfort, Dryness, Handling, Lens Fit Stability and Vision Satisfaction. Collected at 4 weeks wear for each lens. (0-10; Comfort, Lens Fit and Satisfaction / 0=very poor,10=excellent; Dryness / 0=very dry, 10=no dryness; Handling / 0=very difficult, 10=very easy for handling)	4 weeks
Vision Quality Insertion, During Day, End Day, Night	Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 2 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)	2 weeks
Vision Quality Insertion, During Day, End Day, Night	Participant rating of vision quality on insertion, during the day, end of day and night. Collected at 4 weeks wear for each lens. (0-100; 0=extremely poor vision totally blurred, 100=excellent vision totally sharp)	4 weeks
Vision Stability on Insertion, During Day, End Day	Participant rating of vision stability on insertion, during the day, end of day. Collected at 2 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)	2 weeks
Vision Stability on Insertion, During Day, End Day	Participant rating of vision stability on insertion, during the day, end of day. Collected at 4 weeks wear for each lens. (0-100; 0=totally unstable fluctuating/changing, 100=perfectly stable not fluctuating/changing)	4 weeks
Overall Sensation of Moistness	Participant rating for overall sensation of moistness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)	2 weeks
Overall Sensation of Moistness	Participant rating for overall sensation of moistness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)	4 weeks
Overall Sensation of Smoothness	Participant rating for overall sensation of smoothness. Collected at 2 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)	2 weeks
Overall Sensation of Smoothness	Participant rating for overall sensation of smoothness. Collected at 4 weeks wear for each lens. (5-point Likert Scale; Excellent, Good, Average, Below Average, Poor)	4 weeks
Comfort Satisfaction	Participant rating for comfort satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	2 weeks
Comfort Satisfaction	Participant rating for comfort satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	4 weeks
Dryness Satisfaction	Participant rating for dryness satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	2 weeks
Dryness Satisfaction	Participant rating for dryness satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	4 weeks
Handling Satisfaction	Participant rating for handling satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	2 weeks
Handling Satisfaction	Participant rating for handling satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	4 weeks
Vision Satisfaction	Participant rating for vision satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	2 weeks
Vision Satisfaction	Participant rating for vision satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	4 weeks
Lens Fit Satisfaction	Participant rating for lens fit satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	2 weeks
Lens Fit Satisfaction	Participant rating for lens fit satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	4 weeks
Overall Satisfaction	Participant rating for overall satisfaction. Collected at 2 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	2 weeks
Overall Satisfaction	Participant rating for overall satisfaction. Collected at 4 weeks wear for each lens. (4-point Likert Scale; Completely Satisfied, Somewhat Satisfied, Somewhat Dissatisfied, Completely Dissatisfied)	4 weeks
Wavefront Aberrations Root Mean Square (RMS) (3mm)	Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).	2 Weeks
Wavefront Aberrations RMS (3mm)	Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (3mm), Scale in microns (µm).	4 Weeks
Wavefront Aberrations RMS (5mm)	Assessment of wavefront aberrations. Collected at 2 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).	2 Weeks
Wavefront Aberrations RMS (5mm)	Assessment of wavefront aberrations. Collected at 4 weeks for each lens. Wavefront measurement (5 mm), Scale in microns (µm).	4 Weeks
Visual Acuity logMAR	Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 2 weeks for each lens. logMAR (VA). Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)	2 Weeks
Visual Acuity logMAR	Assessment of monocular and binocular high and low contrast visual acuity (VA). Collected at 4 weeks for each lens. logMAR (VA). Monocular High Contrast Visual Acuity (MHCVA), Monocular Low Contrast Visual Acuity (MLCVA), Binocular High Contrast Visual Acuity (BHCVA), Binocular Low Contrast Visual Acuity (BLCVA)	4 Weeks
Lens Orientation Primary Gaze	Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 2 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)	2 weeks
Lens Orientation Primary Gaze	Assessment of Lens Fit Performance for lens orientation in primary position of gaze. Assessed at 4 weeks wear for each lens. (Degree of mislocation relative to lens axis mark.)	4 weeks
Rotational Recovery 30/45 Deg	Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)	2 weeks
Rotational Recovery 30/45 Deg	Assessment of Lens Fit Performance for lens rotational recovery to original position. Collected at 2 weeks wear for each lens. Assessed in degree of mislocation relative to original position after manual temporal rotation. (30 deg/10 blinks, 45 deg/60 sec)	4 weeks
Lens Surface Deposits	Assessment of lens front surface deposits. Collected at 2 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)	2 weeks
Lens Surface Deposits	Assessment of lens front surface deposits. Collected at 4 weeks wear for each lens. (Front surface deposits observed, 0-4, 0=clean, 4=deposits ≥0.5)	4 weeks
Centration	Assessment of Lens Fit Performance for centration. Collected at 2 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)	2 weeks
Centration	Assessment of Lens Fit Performance for centration. Collected at 4 weeks for each lens. Proportion of contact lenses fitted where centration was centered or slightly decentered. (Biomicroscopy)	4 weeks
Corneal Coverage	Assessment of Lens Fit Performance for corneal coverage. Collected at 2 weks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)	2 weeks
Corneal Coverage	Assessment of Lens Fit Performance for corneal coverage. Collected at 4 weeks for each lens. Corneal coverage assessed in primary gaze: (yes=full corneal coverage at all times, no=incomplete corneal coverage)	4 weeks
Post Blink Movement	Assessment of Lens Fit Performance for post blink movement. Collected at 2 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)	2 weeks
Post Blink Movement	Assessment of Lens Fit Performance for post blink movement. Collected at 4 weeks for each lens. (0-4, 0.5 increments; 0=Insufficient, unacceptable movement, 4= Excessive, unacceptable movement)	4 weeks
Lens Marking Visibility	Assessment of Lens Fit Performance for lens marking visibility. Collected at 2 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)	2 weeks
Lens Marking Visibility	Assessment of Lens Fit Performance for lens marking visibility. Collected at 4 weeks for each lens. (1-3, 1=excellent, 2=average, 3=poor)	4 weeks
Lens Stability on Blink	Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 2 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)	2 weeks
Lens Stability on Blink	Assessment of Lens Fit Performance for lens rotational stability on blink. Collected at 4 weeks for each lens. (No rotation and 5-10 degrees rotation from axis location mark)	4 weeks
Lens Stability 5-10 Min	Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 2 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.	2 weeks
Lens Stability 5-10 Min	Assessment of Lens Fit Performance for lens to stabilize in 5-10 min. Collected at 4 weeks for each lens. Varied less than 5 degrees from lens marking location between 5-10 min.	4 weeks
Overall Stability	Assessment of Lens Fit Performance for overall lens stability. Collected at 2 weeks for each lens. (Excellent or Good.	2 weeks
Overall Stability	Assessment of Lens Fit Performance for overall lens stability. Collected at 4 weeks for each lens. (Excellent or Good.	4 weeks
Overall Fit Acceptance	Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 2 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)	2 weeks
Overall Fit Acceptance	Assessment of Lens Fit Performance for overall lens fit acceptance. Collected at 4 weeks for each lens. Rated perfect or not perfect based on lens fit alone. (0-4; 0=should not be worn, 3=not perfect but OK to dispense, 4=perfect)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limbal Hyperaemia	Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	Baseline
Limbal Hyperaemia	Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	2 weeks
Limbal Hyperaemia	Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	4 weeks
Bulbar Hyperaemia	Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	Baseline
Bulbar Hyperaemia	Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	2 weeks
Bulbar Hyperaemia	Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	4 weeks
Lower Palpebral Hyperaemia	Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	Baseline
Lower Palpebral Hyperaemia	Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	2 weeks
Lower Palpebral Hyperaemia	Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	4 weeks
Corneal Stromal Haze	Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	Baseline
Corneal Stromal Haze	Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	2 weeks
Corneal Stromal Haze	Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	4 weeks
Corneal Neovascularization	Investigators' objective assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	Baseline
Corneal Neovascularization	Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	2 weeks
Corneal Neovascularization	Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	4 weeks
Corneal Infiltrates	Assessment of ocular health. Collected at baseline after removal of habitual lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	Baseline
Corneal Infiltrates	Assessment of ocular health. Collected at 2 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	2 weeks
Corneal Infiltrates	Assessment of ocular health. Collected at 4 weeks after removal of lenses. Proportion of eyes with grades 0-1 (No eyes graded >1) (Biomicroscopy, 0-4, ½ grades; 0=none: no injection present, 4=severe)	4 weeks
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)	Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)	2 weeks
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)	Participant preference for their habitual lenses or the first study lenses during the last two weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)	2 weeks
Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B)	Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)	4 weeks
Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A)	Participant preference for their habitual lenses or the first study lenses during the last four weeks with regard to comfort, dryness, handling, vision, lens fit and overall. (Forced choice; habitual, study lenses)	4 weeks
Participants Likelihood of Switching From Habitual Lenses to the Study Lenses	Participants likelihood of switching from habitual lenses to either pair of the study lenses when asked; How likely are they to switch from their habitual lenses to either the first study lenses or the second study lenses?" Collected at 4 weeks for each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)	4 weeks
Participants Likelihood of Continuing to Wear the Study Lenses.	Participants likelihood of continuing to wear either of the pairs of study lenses when asked; "How likely are they to continue to wearing either the first study lenses or the second study lenses?" Collected at 4 weeks fore each study pair. (4 point Likert scale; very likely, likely, unlikely, very unlikely)	4 weeks
Participant Recommendation of a Study Lens to Friends, Family or Colleagues	Percentage of participants that answer the question, "What study lens they will most likely recommend to friends, family or colleagues?" Collected at end of study. (Forced choice; First Study Lenses, Second Study Lenses)	8 weeks
Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues.	Percentage of participants that answer the question, "How likely are they to recommend either the first pair of study lenses or the second pair of study lenses to friends, family or colleagues?" Collected at study end. (4 point Likert scale; very likely, likely, unlikely, very unlikely)	8 weeks
Participant Preference for Their Habitual Lenses or Either of the Study Lenses	Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; habitual lenses, first study lenses, second study lenses)	8 weeks
Participant Preference for Either of the Study Lenses	Percentage of participants that answer the question, "Which type of study lens they prefer with regard to comfort, dryness, handling, vision, lens fit and overall performance?" Collected at study end. (Forced choice; first study lenses, second study lenses, neither)	8 weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Robert Montés-Mico, OD MPhil PhD, Optometry Research Group (GIO) - Optics Department, University of Valencia

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (ACTUAL): December 1, 2013
• Study Completion (ACTUAL): May 1, 2014

Study Registration Dates

• First Submitted: October 11, 2013
• First Submitted That Met QC Criteria: October 15, 2013
• First Posted (ESTIMATE): October 18, 2013

Study Record Updates

• Last Update Posted (ACTUAL): July 30, 2020
• Last Update Submitted That Met QC Criteria: July 19, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: EX-MKTG-42