A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
Status
Completed
Conditions
Corneal Staining
Treatments
Other: Multipurpose Solution #1
Other: Multipurpose Solution #4
Other: Multipurpose Solution #2
Other: Mutlipurpose Solution #3
Details and patient eligibility
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.
Enrollment
32 patients
Sex
All
Ages
18+ years old
Volunteers
Accepts Healthy Volunteers
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
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Crossover Assignment
Masking
Double Blind
32 participants in 4 patient groups
Multipurpose Solution #1
Experimental group
Description:
B\&L Renu Fresh Multipurpose Solution
Treatment:
Other: Mutlipurpose Solution #3
Other: Multipurpose Solution #2
Other: Multipurpose Solution #4
Other: Multipurpose Solution #1
Multipurpose Solution #2
Experimental group
Description:
OptiFree Replenish Multipurpose Solution
Treatment:
Other: Mutlipurpose Solution #3
Other: Multipurpose Solution #2
Other: Multipurpose Solution #4
Other: Multipurpose Solution #1
Multipurpose Solution #3
Experimental group
Description:
Ciba ClearCare Multipurpose Solution
Treatment:
Other: Mutlipurpose Solution #3
Other: Multipurpose Solution #2
Other: Multipurpose Solution #4
Other: Multipurpose Solution #1
Multipurpose Solution #4
Active Comparator group
Description:
Saline Solution
Treatment:
Other: Mutlipurpose Solution #3
Other: Multipurpose Solution #2
Other: Multipurpose Solution #4
Other: Multipurpose Solution #1
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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