N/A
N=444
Study of A New Contact Lens Cleaning and Disinfecting Solution
Vision Disorders
Bottom Line
View on ClinicalTrials.gov: NCT01318577 ↗Enrolled (actual)
444
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcome: Primary: Percentage of Eyes With > Grade 2 Slit Lamp Findings — 4; 0 eyes
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Investigational Cleaning & Disinfecting Solution (Device); Clear Care Solution (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Apr 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eyes With > Grade 2 Slit Lamp Findings |
4; 0 | — |
Summary
The objective of this study is to evaluate the safety and efficacy of a new investigational cleaning and disinfecting solution (Test) compared to Clear Care cleaning and disinfecting solution (Control) when used by contact lens wearers to clean and disinfect their contact lenses for approximately three months.
Eligibility Criteria
Inclusion Criteria
- Subjects must be habitual wearers of one of the protocol specified lenses.
- Subjects must habitually use a NON-PEROXIDE lens care product for cleaning, disinfecting and storage of their lenses.
- Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
- Subjects must agree to wear their lenses on a daily wear basis for approximately three months.
Exclusion Criteria
- Subjects who currently use a hydrogen peroxide cleaning and disinfecting solution.
- Subjects who currently wear Opaque Cosmetic Tint Contact Lenses.
- Subjects who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- Subjects with any systemic disease currently affecting ocular health or which in the Investigator"s opinion may have an effect on ocular health during the course of the study.
- Subjects using any systemic or topical medications that will, in the Investigator"s opinion, affect ocular physiology or lens performance.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator"s judgment, interferes with contact lens wear.
- Subjects with any scar or neovascularization within the central 4 mm of the cornea.
- Subjects who are allergic to any component in the study care products.
Data sourced from ClinicalTrials.gov (NCT01318577). 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.