N/A
N=166
Study to Evaluate a Contact Lens Lubricating and Rewetting Drop
Dry Eye
Bottom Line
View on ClinicalTrials.gov: NCT01267656 ↗Enrolled (actual)
166
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcome: Primary: Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2. — 1; 0 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lubricating and Rewetting Drops (Device); AMO Blink Contacts Lubricant Eye Drops (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eyes With Graded Slit Lamp Findings Greater Than Grade 2. |
1; 0 | — |
Summary
The objective of this study is to evaluate the product performance of investigational lubricating and rewetting drops.
Eligibility Criteria
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.
- Aphakic.
- Amblyopic.
- Allergic to any component in the study care products.
- Have had any corneal surgery.
Data sourced from ClinicalTrials.gov (NCT01267656). 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.