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

CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: fanfilcon A test lens

Device: etafilcon A control lens

Device: ocufilcon D control lens

Study type

Interventional

Funder types

Industry

Identifiers

NCT04050618

EX-MKTG-103

Details and patient eligibility

About

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.

Full 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.

Enrollment

114 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.