N/A
N=212
Product Performance of a Daily Disposable Contact Lens
Myopia
Bottom Line
View on ClinicalTrials.gov: NCT01230554 ↗Enrolled (actual)
212
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcome: Primary: Market Research Survey — 10; 91; 93; 16 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Daily disposable cosmetic tint lens (Device)
- Age
- Pediatric, Adult · 15+ yrs
- Sex
- Female
- Sponsor
- Bausch & Lomb Incorporated
- Primary completion
- Oct 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Market Research Survey |
10; 91; 93; 16; 0 | — |
| SECONDARY Lens Evaluation - Centration |
287; 109; 14; 14 | — |
| SECONDARY Lens Evaluation - Movement |
246; 0; 168; 10 | — |
| SECONDARY Visual Acuity - Distance High Contrast logMAR (Logarithm of the Minimum Angle of Resolution) Lens Visual Acuity (VA). |
0.012 | — |
Summary
The objective of this one week, single group, bilateral, open-label study is to evaluate the product performance of the Bausch & Lomb daily disposable cosmetic tint contact lens (Test) when worn on a daily disposable basis by adapted current wearers of a marketed opaque tinted soft contact lens.
Eligibility Criteria
Inclusion Criteria
- Subjects must be females of Chinese descent and of legal age and no older than 38. OR subjects that are females of Chinese descent and are at least 15 years of age and less than the legal age must: have a parent/legal guardian provide informed consent.
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted current wearers of marketed opaque tinted soft contact lenses, wear their lenses two days or more per week, and wear a lens in each eye.
Exclusion Criteria
- Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or have worn polymethylmethacrylate (PMMA) lenses within the last three months.
- 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 scar or neovascularization within the central 4 mm of the cornea.
- Subjects who are aphakic or amblyopic.
- Subjects who have had any corneal surgery (eg, refractive surgery).
- Subjects who currently wear monovision, multifocal, or toric contact lenses.
Data sourced from ClinicalTrials.gov (NCT01230554). 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.