N/A
Completed N=368
Evaluation of Two Different Designs of Bausch & Lomb Contact Lenses
Source: ClinicalTrials.gov NCT01118338 ↗Enrolled (actual)
368
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Symptoms and Complaints — 83.2; 83.6; 78.1; 74.6 score on a scale
Summary
The objective of this one month study is to evaluate the product performance of a redesigned PureVision Contact Lens compared to the PureVision Contact Lens when worn on a daily wear basis by wearers of contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Symptoms and Complaints |
83.2; 83.6; 78.1; 74.6; 84.6; 83.2 | — |
| SECONDARY Visual Acuity |
-0.028; -0.021 | — |
| SECONDARY Percentage of Eyes With > Grade 2 Slit Lamp Findings |
5; 5 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted wearers of one of the listed contact lenses
- Subjects must be myopic
- Subjects must use a lens care system on a regular basis.
Exclusion Criteria
- Subjects who have worn gas permeable (GP) contact lenses within the last 30 days of polymethylmethacrylate (PMMA) lenses within the last 3 months.
- Subjects with 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 who have had any corneal surgery (eg, refractive surgery).
- Subjects who have participated in any drug or device clinical investigation within two weeks prior to entry into this study and/or during the period of study participation.
Data sourced from ClinicalTrials.gov (NCT01118338). 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.