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Corneal Staining

A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

Sponsored by Coopervision, Inc.

About this trial

Last updated 5 years ago

Study ID

CV-09-64, Sterling IRB 3576

Status

Completed

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Trial Timing

Ended 15 years ago

What is this trial about?

This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.

What are the participation requirements?

Yes

Inclusion Criteria

- Informed Consent and HIPAA document read, signed, and dated.

- Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.

- Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.

No

Exclusion Criteria

- History of hypersensitivity

- Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye

- One functional eye or a monofit eye

- Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis

- Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period

- Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period

- Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period

- Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period

- Abnormal lenticular opacity in the visual axis of the lens in either eye

- Use of concomitant topical Rx or over-the-counter (OTC) ocular medications

- History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear

- Pregnant or lactating females