Performance of Toric Hydrogel Lenses Following A Refit With Toric Silicone Hydrogel Lenses for 1 Month

The aim of this prospective study is to evaluate the clinical performance of habitual wearers of methafilcon A toric lenses after a refit with fanfilcon A toric lenses for 1-month of daily wear.

Study Overview

• Status: Completed
• Conditions: Ametropia
• Intervention / Treatment: Device: methafilcon A toric contact lenses; Device: fanfilcon A toric contact lenses

• Study Type: Interventional
• Enrollment (Actual): 43
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Mexico City, Mexico
    • Optometry Clinic, National Autonomous University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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 contact lens wearer
• Has a contact lens spherical prescription between +6.00 to - 8.00 (inclusive)-Have no less than -0.75D of astigmatism and no more than -2.25 D 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:

• Has a Contact Lens (CL) prescription outside the range of the available parameters of the study lenses
• Has a spectacle cylinder less than -0.75D or more than -2.50 D of cylinder in either eye
• Has a history of not achieving comfortable Contact Lens (CL) 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: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: methafilcon A toric / fanfilcon A toric contact lenses; All subjects will first wear methafilcon A toric contact lenses for four (4) weeks of daily wear, then refitted with fanfilcon A toric contact lenses for four (4) weeks of daily wear.	Device: methafilcon A toric contact lenses; Bilateral daily wear of methafilcon A toric contact lenses; Device: fanfilcon A toric contact lenses; Bilateral daily wear of fanfilcon A toric contact lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Number of Participants With Lens Centration Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4 weeks
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	Baseline
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	2 weeks
Number of Participants With Lens Centration Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens centration was assessed on a 3-point scale (1=optimal centration, 2=decentration acceptable, 3=decentration unacceptable).	4 weeks
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea	Baseline
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea	4 weeks
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea	Baseline
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea	2 weeks
Percentage of Participants With Corneal Coverage Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Corneal coverage was collected on a YES/NO response. Yes - lens covers the cornea, No - lens does not cover the cornea	4 weeks
Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).	Baseline
Post-blink Movement Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).	4 weeks
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).	Baseline
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).	2 weeks
Post-blink Movement Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Post-blink movement was assessed on a 0-4 scale (where: 0=Insufficient, unacceptable movement,1=Minimal, but acceptable movement, 2=Optimal movement, 3=Moderate, but acceptable movement, 4=Excessive, unacceptable movement).	4 weeks
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.	Baseline
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Methalfilcon A Toric Contact Lenses	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.	4 weeks
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.	Baseline
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.	2 weeks
Lens Orientation in Primary Position of Gaze Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens orientation was assessed in 5-degree steps with the slit lamp by measuring the amount of mislocation of the axis mark on the lens relative to the 6 o'clock position.	4 weeks
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position	Baseline
Rotational Recovery Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position	4 weeks
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position	Baseline
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position	2 weeks
Rotational Recovery Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Lens rotational recovery was assessed in 5-degree steps 1 minute after the lens was manually rotated 45degrees temporally from the primary gaze position	4 weeks
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).	Baseline
Overall Stability Assessment by the Investigator - Methafilcon A Toric Contact Lenses	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).	4 weeks
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).	Baseline
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).	2 weeks
Overall Stability Assessment by the Investigator - Fanfilcon A Toric Contact Lenses	Overall lens stability was assessed using a 0 - 4 scale (where 0 = very poor stability, and 4 = excellent stability).	4 weeks
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses	Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.	Baseline
Overall Lens Fit Acceptance by the Investigator - Methafilcon A Toric Contact Lenses	Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.	4 weeks
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.	Baseline
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.	2 weeks
Overall Lens Fit Acceptance by the Investigator - Fanfilcon A Toric Contact Lenses	Overall lens fit acceptance assessed using grade (0-4) 0=Should not be worn, 1=Borderline but unacceptable, 2=Minimal acceptable, early review, 3=Not perfect but okay to dispense, 4=perfect.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Average Daily Wearing Time - Methafilcon A Toric Contact Lenses	Average daily wearing time response by the subject	4 weeks
Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses	Average daily wearing time response by the subject	2 weeks
Average Daily Wearing Time - Fanfilcon A Toric Contact Lenses	Average daily wearing time response by the subject	4 weeks
Average Comfortable Wearing Time - Methafilcon A Toric Contact Lenses	Average comfortable wearing time - response by the subject	4 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses	Average comfortable wearing time - response by the subject	2 weeks
Average Comfortable Wearing Time - Fanfilcon A Toric Contact Lenses	Average comfortable wearing time - response by the subject	4 weeks

Collaborators and Investigators

• Sponsor: CooperVision, Inc.
• Investigators: Principal Investigator: Ruben Velazquez, MSc FIACLE, School of Optometry, National Autonomous University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): March 27, 2019
• Study Completion (Actual): July 6, 2019

Study Registration Dates

• First Submitted: January 31, 2019
• First Submitted That Met QC Criteria: February 6, 2019
• First Posted (Actual): February 8, 2019

Study Record Updates

• Last Update Posted (Actual): June 11, 2020
• Last Update Submitted That Met QC Criteria: May 26, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: EX-MKTG-96

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes