Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

Myopia Clinical Trial

Official title:

Multi-Center Cross-Over Evaluation Of Avaira Vitality Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04050618
• Other study ID #: EX-MKTG-103
• Status: Completed
• Phase: N/A
• Start date: June 9, 2019
• Est. completion date: November 8, 2019

Study information

• Verified date: September 2020
• Source: Coopervision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.

Description:

This 8-week, subject-masked, bilateral, two-part, cross-over evaluation will compare the clinical performance of fanfilcon A silicone hydrogel contact lens and competitive hydrogel contact lenses when worn daily. Lenses will be replaced either on a 2-weekly or 4-weekly basis, depending on control lens group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: November 8, 2019
• Est. primary completion date: September 24, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Be a currently adapted soft contact lens wearer (>1 month of lens wear).

• Be at least 18 years of age.

• Refractive astigmatism <1.00D in both eyes.

• Have clear corneas and be free of any anterior segment disorders.

• Be correctable through spherocylindrical refraction to 20/25 or better in each eye.

• Contact lens sphere requirement between -1.00D and -6.00D (inclusive).

• Require visual correction in both eyes (monovision allowed, no monofit).

• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:

1. No amblyopia

2. No strabismus

3. No evidence of lid abnormality or infection

4. No conjunctival abnormality or infection that would contraindicate contact lens wear

5. No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)

6. No other active ocular disease.

• Own a mobile phone and be able to respond to SMS survey during the period 8am-8pm.

• Willing to comply with the wear and study visit schedule.

Exclusion Criteria:

• Using CooperVision Avaira Vitality, J&J Acuvue 2 or CooperVision Biomedics 55.

• Require toric or multifocal contact lenses.

• Previously shown a sensitivity to any of the study solution components.

• Any systemic or ocular disease or allergies affecting ocular health.

• Using systemic or topical medications that will in the investigator's opinion affect ocular physiology or lens performance.

• Clinically significant (>Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.

• Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.

• Keratoconus or other corneal irregularity.

• Aphakia or amblyopia.

• Have undergone corneal refractive surgery or any anterior segment surgery.

• Abnormal lacrimal secretions.

• Has diabetes.

• Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).

• History of chronic eye disease (e.g. glaucoma).

• Pregnant or lactating or planning a pregnancy at the time of enrolment.

• Participation in any concurrent clinical trial or in last 30 days.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• fanfilcon A test lens
Silicone hydrogel contact lens
• ocufilcon D control lens
hydrogel contact lens
• etafilcon A control lens
hydrogel contact lens

Locations

Country	Name	City	State
United States	Omega Vision Center PA (DBA Sabal Eye Care)	Longwood	Florida
United States	Office of William J. Bogus, O.D.	Salt Lake City	Utah
United States	Golden Vision	Sarasota	Florida
United States	Frazier Vision, Inc	Tyler	Texas
United States	Sacco Eye Group	Vestal	New York
United States	Golden Optometric Group	Whittier	California

Sponsors (1)

Lead Sponsor	Collaborator
Coopervision, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Subjective Overall Comfort Rating	Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses	Two weeks
Primary	Subjective Overall Comfort Rating	Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses	Four weeks
Secondary	Average Wearing Time	Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes	Two weeks
Secondary	Average Wearing Time	Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes	Four weeks
Secondary	Average Comfortable Wearing Time	Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.	Two weeks
Secondary	Average Comfortable Wearing Time	Average comfortable wearing time was assessed by time of day when first aware of lenses using 24-hour clock, to the nearest 10 minutes.	Four weeks
Secondary	Lens Centration	Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).	Baseline (after 15 minutes)
Secondary	Lens Centration	Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).	Two weeks
Secondary	Lens Centration	Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (>0.5mm)).	Four weeks
Secondary	Corneal Coverage	Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)	Baseline (after 15 minutes of lens dispense)
Secondary	Corneal Coverage	Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)	Two weeks
Secondary	Corneal Coverage	Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)	Four weeks
Secondary	Post-Blink Movement	Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Baseline (after 15 minutes of lens dispense)
Secondary	Post-Blink Movement	Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Two weeks
Secondary	Post-Blink Movement	Post-blink movement measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Four weeks
Secondary	Lens Tightness - Push-up Test	Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)	Baseline (after 15 minutes of lens dispense)
Secondary	Lens Tightness - Push-up Test	Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)	Two weeks
Secondary	Lens Tightness - Push-up Test	Lens tightness - push-up test 0-100% continuous scale (100%=movement, 50%=optimum, 0%=Falls from cornea without lid support)	Four weeks
Secondary	Overall Lens Fit Acceptance	Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)	Baseline (after 15 minutes of lens dispense)
Secondary	Overall Lens Fit Acceptance	Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)	Two weeks
Secondary	Overall Lens Fit Acceptance	Overall lens fit acceptance - Graded on a scale of 0-4 (0=should not be worn, 1=borderline but not acceptable, 2=minimal acceptable, 3=not perfect but OK to dispense, 4=perfect)	Four weeks
Secondary	Rating of Lens Surface Wettability	Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).	Baseline (after 15 minutes of lens dispense)
Secondary	Rating of Lens Surface Wettability	Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).	Two weeks
Secondary	Rating of Lens Surface Wettability	Lens surface wettability rated on the appearance on the lens surface (0-4 scale, 0=Very poor: immediately displaying non-wetting areas on lens surface, 4=Excellent: appearance of a healthy cornea with very long drying time).	Four weeks
Secondary	Presence of Film Deposits	Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).	Two weeks
Secondary	Presence of Film Deposits	Presence of film deposits on front surface of the lens graded 0-4 (0=No film, 1=Slight film visible only under magnification, 2=Moderate film only under magnification, 3=Moderate film visible to the naked eye, 4=heavy film visible to the naked eye).	Four weeks
Secondary	Number of White Spot Deposits	Number of white spot deposits assessed using slit lamp with white light, low medium magnification	Two weeks
Secondary	Number of White Spot Deposits	Number of white spot deposits assessed using slit lamp with white light, low medium magnification	Four weeks
Secondary	Primary Gaze Lag	Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Baseline (after 15 minutes of lens dispense)
Secondary	Primary Gaze Lag	Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Two weeks
Secondary	Primary Gaze Lag	Primary gaze lag measured by scale 0-4 (0=insufficient, 1=minimal, unacceptable movement, 2=optimal movement, 3=moderate, but acceptable movement, 4=excessive, unacceptable movement)	Four weeks
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 3 - 8:00am
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 3 - 12:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 3 - 4:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 3 - 8:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 7 - 8:00am
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 7 - 12:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 7 - 4:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 7 - 8:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 12 - 8:00am
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 12 - 12:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 12 - 4:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 12 - 8:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 26 - 8:00am
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 26 - 12:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 26 - 4:00pm
Secondary	Comfort Throughout the Day	Comfort throughout the day was assessed on a scale of 0-10 (0=extremely uncomfortable, 10=cannot feel the lenses) using text message responses	Day 26 - 8:00pm