Status:
COMPLETED
Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
Lead Sponsor:
CooperVision, Inc.
Conditions:
Myopia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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.
Detailed 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...
Eligibility Criteria
Inclusion
- 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:
- No amblyopia
- No strabismus
- No evidence of lid abnormality or infection
- No conjunctival abnormality or infection that would contraindicate contact lens wear
- No clinically significant slit lamp findings (i.e. corneal staining, stromal edema, staining, scarring, vascularization, infiltrates or abnormal opacities)
- 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
- 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.
Key Trial Info
Start Date :
June 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 8 2019
Estimated Enrollment :
114 Patients enrolled
Trial Details
Trial ID
NCT04050618
Start Date
June 9 2019
End Date
November 8 2019
Last Update
October 19 2020
Active Locations (6)
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1
Golden Optometric Group
Whittier, California, United States, 90606
2
Omega Vision Center PA (DBA Sabal Eye Care)
Longwood, Florida, United States, 32779
3
Golden Vision
Sarasota, Florida, United States, 34232
4
Sacco Eye Group
Vestal, New York, United States, 13850