N/A
Completed N=302
A Study to Evaluate the Performance of Two Designs of Soft Toric Lenses
Source: ClinicalTrials.gov NCT01309867 ↗Enrolled (actual)
302
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees. — 489; 426 eyes
Summary
The objective of the study is to evaluate the product performance of the Bausch + Lomb toric investigational contact lenses compared to the currently marketed PureVision toric contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Eyes With Absolute Lens Rotation ≤ 10 Degrees. |
489; 426 | — |
| PRIMARY Visual Acuity |
-0.025; -0.021 | — |
| SECONDARY Symptoms and Complaints |
85.4; 82.0; 77.7; 74.3; 77.3; 67.9 | — |
| SECONDARY Percentage of Eyes With > Grade 2 Slit Lamp Findings |
1; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects must have clear central corneas and be free of any anterior segment disorders.
- Subjects must be adapted lens wearers, wear a lens in each eye and each lens must be of the same manufacture and brand.
- Subjects must be myopic and require lens correction
- Subjects must be habitual wearers of toric soft contact lenses.
Exclusion Criteria
- 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 an active ocular disease or who are using any ocular medication.
- Subjects with any grade 2 or greater finding during the slit lamp examination. Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
- Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
- Subjects who are allergic to any component in the study care products.
Data sourced from ClinicalTrials.gov (NCT01309867). 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.