Study to Evaluate the Product Feasibility of a Contact Lens Lubricating and Rewetting Drop
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bausch & Lomb Incorporated
- Enrollment
- 168
- Locations
- 1
- Primary Endpoint
- Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
Study Overview
Brief Summary
The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Screening
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
- •Adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- •Use a lens care system on a regular basis.
- •Wear their habitual lenses (or be willing to wear lenses) a minimum of 8 hours per day.
- •Willing to use drops 4 times per day.
Exclusion Criteria
- •Participating in a conflicting study.
- •An active ocular disease, any corneal infiltrative response, or are using any ocular medications.
- •Any scar or neovascularization within the central 4mm of the cornea.
- •Any grade 2 or greater finding during the slit lamp examination
- •Using any systemic or topical medications that will affect ocular physiology or lens performance.
- •Amblyopic.
- •Allergic to any component in the study care products.
- •Have had any corneal surgery.
Arms & Interventions
Lubricating and Rewetting Drops
Lubricating and Rewetting Drops, after one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week.
Intervention: Lubricating and Rewetting Drops (Device)
AMO Blink Contacts Lubricant Eye Drops
AMO Blink Contacts Lubricant Eye Drops, After one week of using the first rewetting drops, the subjects will return for an exam and crossover to the second rewetting drops for one week
Intervention: AMO Blink Contacts Lubricant Eye Drops (Device)
Outcomes
Primary Outcomes
Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2.
Time Frame: At 1 week follow up
Slit lamp findings for epithelial edema, epithelial microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates were graded 0 to 4, with 0 = none to 4 = severe. The outcome measure is any finding \> grade 2, across abnormalities.
Secondary Outcomes
No secondary outcomes reported