N/A
N=28
Clinical Evaluation of Opti-Free III (FID 109182) Compared to Opti-Free Plus® in Japan
Corneal Staining
Bottom Line
View on ClinicalTrials.gov: NCT02251561 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcome: Primary: Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein — 92.6; 22.2 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- FID 109182 (Device); Opti-Free Plus (Device); Senofilcon A contact lens (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Alcon Research
- Primary completion
- May 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Participants Scoring ≥ 2 for Corneal Staining Density With Fluorescein |
92.6; 22.2 | — |
| SECONDARY Proportion of Participants Scoring ≥ 2 for Corneal Staining Area With Fluorescein |
92.6; 44.4 | — |
Summary
The purpose of this study is to compare an investigational contact lens care product (FID 109182) to a commercially available contact lens product (Opti-Free Plus®) for corneal staining when used with Acuvue® Oasys® contact lenses. The contact lenses will be pre-soaked in the products for 24-48 hours prior to a 2-hour contralateral wear period.
Eligibility Criteria
Inclusion Criteria
- Soft contact lenses habitual wearer, both eyes.
- Voluntarily sign Informed Consent.
- Other protocol-defined inclusion criteria may apply.
Exclusion Criteria
- Unable to tolerate the ingredients in Opti-Free® and similar contact lens care products.
- Potential use of eye drops during the study, including over-the-counter products, except for artificial tear eye drops.
- Eye infection, blepharitis, iris inflammation, or severe eye inflammation.
- Corneal staining greater than Grade 1 at baseline.
- Pregnant, lactating, or intend to become pregnant during study period.
- Other protocol-defined exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT02251561). 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.