Comparative Clinical Evaluation of Soft Toric Lens Designs

This study is evaluating the initial fit of toric contact lenses.

Study Overview

• Status: Completed
• Conditions: Astigmatism; Myopia
• Intervention / Treatment: Device: etafilcon A; Device: nelfilcon A; Device: Filcon II 3

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Farnham, United Kingdom, GU9 7EN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Be greater than or equal to 18 years old.
• Read, understand, and sign written Statement of Informed Consent.
• Appear able and willing to adhere to the instructions set forth in this clinical protocol.
• Be existing soft contact lens wearers (no extended wear in the last 3 months, but silicone hydrogels in daily wear are allowed).
• Require a visual correction in both eyes (monovision allowed but no monofit).
• Have a spherical contact lens requirement in the range -0.50D to -6.00D.
• Have astigmatism of between -0.50 and -2.00DC in both eyes.
• Monocular distance visual acuity correctable to 6/9 (0.2 logMAR) or better in each eye with best sphero-cylindrical refraction.
• Have normal eyes with no evidence of any ocular abnormality or disease. For the purposes of this study a normal eye is defined as one having: Clear cornea, No anterior segment disorder, No clinically significant slit lamp findings (i.e. oedema, staining, scarring, vascularisation, infiltrates or abnormal opacities), No other active ocular disease or recent surgery

Exclusion Criteria:

• Having worn RGP contact lenses within the last 30 days or PMMA contact lenses within the last 3 months.
• Clinically significant corneal oedema, corneal vascularisation, corneal staining, tarsal abnormalities, bulbar injection or any other abnormality of the cornea that would contraindicate contact lens wear.
• Extended lens wear in last 3 months.
• Any systemic or topical medications that will in the investigator's opinion affect ocular physiology or contact lens performance.
• Any systemic disease affecting ocular health.
• Abnormal lacrimal secretions.
• Keratoconus or other corneal irregularity.
• Pregnancy, lactating or planning a pregnancy at the time of enrolment.
• Participation in any concurrent clinical trial.
• Any previous anterior ocular surgery.
• Subjects who are known to have an infectious systemic disease (e.g., hepatitis, tuberculosis).
• Subjects who are known to have an immunosuppressive disease (e.g., HIV positive).
• Subjects who are known to have diabetes.
• Employees or family members of the Research site, Principal Investigator or study team.

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
OTHER: etafilcon A / nelfilcon A / Filcon II 3; etafilcon A worn first then nelfilcon A worn second with Filcon II 3 worn third.	Device: etafilcon A; A daily wear contact lens; Other Names: 1-DAY ACUVUE MOIST for Astigmatism; Device: nelfilcon A; A daily wear contact lens; Other Names: Focus Dailies Toric All Day Comfort; Device: Filcon II 3; a daily disposable; Other Names: Clariti(TM) 1 day Toric
OTHER: nelfilcon A / etafilcon A / Filcon II 3; nelfilcon A worn first then etafilcon A worn second with Filcon II 3 worn third.	Device: etafilcon A; A daily wear contact lens; Other Names: 1-DAY ACUVUE MOIST for Astigmatism; Device: nelfilcon A; A daily wear contact lens; Other Names: Focus Dailies Toric All Day Comfort; Device: Filcon II 3; a daily disposable; Other Names: Clariti(TM) 1 day Toric

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase I: Absolute Lens Rotation	At 1-min after lens insertion, lens orientation position was assessed on a scale of 0-180 degree on both eyes.	At 1-min after lens insertion during Phase I
Phase I: Absolute Lens Rotation	Lens orientation position as assessed on a scale of 0-180 on both eyes.	3 min after lens insertion during Phase I

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase I: Time to Lens Settling	With random insertion and natural blinking, the slit lamp video was used to measure the time of lens settling.	5 minutes after lens insertion during Phase I
Phase I: Number of Blinks Until Settled	Number of blinks for the right eye was counted until lens settling using headcam video.	Baseline to 5 minutes during Phase I

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Phase II: Absolute Rotation	Absolute rotation of the lens (degrees) at 1-minute post-fit on both eyes. Filcon II 3 lens was only used for comparison in phase II of the study per study protocol.	1-minute during Phase II

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (ACTUAL): April 1, 2012
• Study Completion (ACTUAL): April 1, 2012

Study Registration Dates

• First Submitted: March 9, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (ESTIMATE): March 13, 2012

Study Record Updates

• Last Update Posted (ACTUAL): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Astigmatism
• Other Study ID Numbers: CR-4582