N/A
Completed N=40
Visual Performance Investigation of Two Toric Soft Contact Lenses
Source: ClinicalTrials.gov NCT01858701 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcomePrimary: Mean Ocular Coma Score at 5mm Pupil at Day 30 — 0.16; 0.24 micrometers
Summary
The purpose of this study is to compare the amount of coma as measured by aberrometry induced by two silicone hydrogel toric lenses in astigmatic participants.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ocular Coma Score at 5mm Pupil at Day 30 |
0.16; 0.24 | — |
Eligibility Criteria
Inclusion Criteria
- Sign informed consent;
- Wears toric soft contact lenses;
- Can be successfully fit with study lenses within the power ranges available;
- Has cylinder of ≥ -0.75 diopter in both eyes;
- Has correctable vision of at least 0.1 (logMAR) or better in each eye at distance with both study lenses;
- Willing and able to wear study lenses on a daily wear basis for at least 5 days a week, minimum 8 hours per day, and attend all study visits;
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Any ocular condition that would contraindicate contact lens wear;
- Use of medications for which contact lens wear could be contraindicated;
- Monocular (only 1 eye with functional vision) or fit with 1 lens;
- History of herpetic keratitis, ocular surgery, or irregular cornea;
- Known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Requires presbyopic correction;
- Use of rewetting/lubricating eye-drops more than twice a day;
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT01858701). 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.