N/A
Completed N=200
A Study to Assess the Safety and Efficacy of a Daily Disposable Contact Lens
Source: ClinicalTrials.gov NCT01130974 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Slit Lamp Findings — 0; 0 eyes
Summary
The objective of this study is to evaluate the safety and efficacy of the Bausch & Lomb daily disposable tint contact lens (Test) compared to a currently marketed daily disposable cosmetic tint contact lens (Control).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Slit Lamp Findings |
0; 0 | — |
| PRIMARY logMAR Visual Acuity (VA) |
0.010; -0.004; 0.003; -0.013 | — |
| PRIMARY logMAR Visual Acuity (VA) |
0.010; -0.004; 0.003; -0.013 | — |
| SECONDARY Lens Wettability |
129; 134; 41; 39; 2; 3 | — |
| SECONDARY Lens Deposits |
152; 151; 20; 23; 0; 0 | — |
| SECONDARY Lens Centration |
127; 129; 31; 26; 13; 6 | — |
| SECONDARY Lens Movement |
167; 152; 0; 18; 5; 6 | — |
| SECONDARY Symptoms & Complaints |
90.3; 84.6; 87.1; 83.1; 82.0; 77.3 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
- Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
- Subjects must be of Asian descent.
- Subjects must require plano or myopic correction and must require contact lens correction from plano to -6.00 D in both eyes.
Exclusion Criteria
- Subjects who have any systemic disease affecting ocular health.
- Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
- Subjects with an active ocular disease or are using any ocular medication.
- 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 with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
- Subjects who currently wear monovision, multifocal, or toric contact lenses.
- Subjects who are adapted wearers of 1-Day Acuvue Define daily disposable cosmetic tint contact lenses.
Data sourced from ClinicalTrials.gov (NCT01130974). 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. Informational only — not medical advice.