N/A
N=32
A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
Corneal Staining
Bottom Line
View on ClinicalTrials.gov: NCT01335750 ↗Enrolled (actual)
32
Serious AEs
0.0%
Results posted
Mar 2013
Primary outcome: Primary: Corneal Staining Severity — 0.01; 0.01; 0.02; 0.01 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Multipurpose Solution #1 (Other); Multipurpose Solution #2 (Other); Mutlipurpose Solution #3 (Other); Multipurpose Solution #4 (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- CooperVision, Inc.
- Primary completion
- Sep 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Staining Severity |
0.01; 0.01; 0.02; 0.01; 0.10; 0.76 | — |
| PRIMARY Corneal Staining Area |
0.1; 0.1; 0.2; 0.1; 1.2; 17.1 | — |
| SECONDARY Subjective Comfort |
82.9; 80.3; 84.8; 84.7; 83.2; 81.6 | — |
| SECONDARY Subjective Dryness |
84.9; 81.1; 85.0; 85.1; 82.8; 76.9 | — |
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.
Eligibility Criteria
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.
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
Data sourced from ClinicalTrials.gov (NCT01335750). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.