N/A
N=40
Visual Performance Investigation of Two Toric Soft Contact Lenses
Refractive Error · Astigmatism · Myopia · Hyperopia
Bottom Line
View on ClinicalTrials.gov: NCT01858701 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Mean Ocular Coma Score at 5mm Pupil at Day 30 — 0.16; 0.24 micrometers
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lotrafilcon B toric contact lens (Device); Comfilcon A toric contact lens (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- Oct 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Ocular Coma Score at 5mm Pupil at Day 30 |
0.16; 0.24 | — |
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.
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.