A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
- Conditions
- Corneal Staining
- Interventions
- Other: Multipurpose Solution #1Other: Multipurpose Solution #2Other: Mutlipurpose Solution #3Other: Multipurpose Solution #4
- Registration Number
- NCT01335750
- Lead Sponsor
- Coopervision, Inc.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Multipurpose Solution #4 Multipurpose Solution #4 Saline Solution Multipurpose Solution #4 Mutlipurpose Solution #3 Saline Solution Multipurpose Solution #3 Multipurpose Solution #2 Ciba ClearCare Multipurpose Solution Multipurpose Solution #2 Multipurpose Solution #2 OptiFree Replenish Multipurpose Solution Multipurpose Solution #2 Mutlipurpose Solution #3 OptiFree Replenish Multipurpose Solution Multipurpose Solution #1 Mutlipurpose Solution #3 B\&L Renu Fresh Multipurpose Solution Multipurpose Solution #2 Multipurpose Solution #4 OptiFree Replenish Multipurpose Solution Multipurpose Solution #4 Multipurpose Solution #1 Saline Solution Multipurpose Solution #1 Multipurpose Solution #4 B\&L Renu Fresh Multipurpose Solution Multipurpose Solution #2 Multipurpose Solution #1 OptiFree Replenish Multipurpose Solution Multipurpose Solution #1 Multipurpose Solution #2 B\&L Renu Fresh Multipurpose Solution Multipurpose Solution #3 Multipurpose Solution #1 Ciba ClearCare Multipurpose Solution Multipurpose Solution #3 Mutlipurpose Solution #3 Ciba ClearCare Multipurpose Solution Multipurpose Solution #4 Multipurpose Solution #2 Saline Solution Multipurpose Solution #1 Multipurpose Solution #1 B\&L Renu Fresh Multipurpose Solution Multipurpose Solution #3 Multipurpose Solution #4 Ciba ClearCare Multipurpose Solution
- Primary Outcome Measures
Name Time Method Corneal Staining Severity Baseline, 2 Hour Period, 4 Hour Period Severity of staining was recorded for each region using a scale of 0-none to 4-patch \>/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.
Corneal Staining Area Baseline, 2 Hour Period, 4 Hour Period Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.
- Secondary Outcome Measures
Name Time Method Subjective Comfort Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)
Subjective Dryness Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)
Trial Locations
- Locations (1)
Erdey/Searcy Eye Group
🇺🇸Columbus, Ohio, United States