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

CooperVision, Inc.114 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

114

Conditions

Myopia

Interventions

fanfilcon A test lensDEVICE

Silicone hydrogel contact lens

ocufilcon D control lensDEVICE

hydrogel contact lens

etafilcon A control lensDEVICE

hydrogel contact lens

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (6)

Golden Optometric Group

Whittier, California, United States

Omega Vision Center PA (DBA Sabal Eye Care)

Longwood, Florida, United States

Golden Vision

Sarasota, Florida, United States

Sacco Eye Group

Vestal, New York, United States

Outcomes

Primary Outcomes

Subjective Overall Comfort Rating

Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

Time frame: Two weeks

Subjective Overall Comfort Rating

Subjective overall comfort rating was assessed on a 0-10 subjective scale, 0=extremely uncomfortable, 10=can't feel lenses

Time frame: Four weeks

Secondary Outcomes

Average Wearing Time

Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes

Time frame: Two weeks

Average Wearing Time

Average wearing time - measured by time of day using 24-hour clock, to the nearest 10 minutes

Time frame: Four weeks

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.

Time frame: Two weeks

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.

Time frame: Four weeks

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)).

Time frame: Baseline (after 15 minutes)

Data from ClinicalTrials.gov

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Frazier Vision, Inc

Tyler, Texas, United States

Office of William J. Bogus, O.D.

Salt Lake City, Utah, United States

Lens centration will be recorded in the scale of 0 to 2 (0=centered - optimal, 1 = decentered slightly, 2 = substantially decentered (\>0.5mm)).

Time frame: Two weeks

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)).

Time frame: Four weeks

Corneal Coverage

Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

Time frame: Baseline (after 15 minutes of lens dispense)

Corneal Coverage

Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

Time frame: Two weeks

Corneal Coverage

Corneal coverage (yes=full corneal coverage all times / no=incomplete corneal coverage)

Time frame: Four weeks

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)

Time frame: Baseline (after 15 minutes of lens dispense)

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)

Time frame: Two weeks

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)

Time frame: Four weeks

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)

Time frame: Baseline (after 15 minutes of lens dispense)

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)

Time frame: Two weeks

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)

Time frame: Four weeks

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)

Time frame: Baseline (after 15 minutes of lens dispense)

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)

Time frame: Two weeks

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)

Time frame: Four weeks

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).

Time frame: Baseline (after 15 minutes of lens dispense)

Rating of Lens Surface Wettability

Time frame: Two weeks

Rating of Lens Surface Wettability

Time frame: Four weeks

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).

Time frame: Two weeks

Presence of Film Deposits

Time frame: Four weeks

Number of White Spot Deposits

Number of white spot deposits assessed using slit lamp with white light, low medium magnification

Time frame: Two weeks

Number of White Spot Deposits

Number of white spot deposits assessed using slit lamp with white light, low medium magnification

Time frame: Four weeks

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)

Time frame: Baseline (after 15 minutes of lens dispense)

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)

Time frame: Two weeks

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)

Time frame: Four weeks

Comfort Throughout the Day