Clinical Performance of Hydrogel vs. Silicone Hydrogel Contact Lenses
Sponsored by CooperVision, Inc.
About this trial
Last updated 9 years ago
Study ID
Status
Type
Phase
Placebo
Accepting
Trial Timing
Ended 12 years ago
What is this trial about?
What are the participation requirements?
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 CL (Contact Lens) wearer
* Has a CL spherical prescription between - 1.00 and - 10.00 (inclusive)
* Has a spectacle cylinder up to 0.75D (Diopter) in each eye.
* 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
* Is willing to comply with the visit schedule
Exclusion Criteria
* Has never worn contact lenses before.
* Currently wears rigid gas permeable contact lenses.
* Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
* Has a CL prescription outside the range of - 1.00 to -10.00D
* Has a spectacle cylinder ≥1.00D of cylinder in either eye.
* 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:
* 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.
