Effect of FID 114675A on Lens Wettability

Not Applicable

Completed

• Conditions: Contact Lens Wettability

• Registration Number: NCT01342107
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate lens wettability of contact lenses when used with an investigational multi-purpose disinfecting solution.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-01-07
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Study First Submitted QC: 2011-04-25
• Study First Posted: 2011-04-27
• Status Verified: 2012-03
• Results First Submitted: 2012-03-21
• Results First Submitted QC: 2012-03-21
• Last Update Submitted: 2012-03-21
• Results First Posted: 2012-04-13
• Last Update Posted: 2012-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• 18 years or age or older with normal eyes, other than correction for refractive error.
• At least 5 days successful daily wear (minimum 8 hours per day) of PureVision®, Acuvue® Oasys™, or Acuvue® 2 contact lenses prior to Visit 1
• Vision correctable to 20/30 (Snellen) or better in each eye at distance with lenses at Visit 1 (Day 0 - Baseline).
• Grade 0 or Grade 1 wettability in both eyes after at least 15 minutes of lens wear at Visit 1 (Day 0 - Baseline).
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria

• Any ocular or systemic medical condition that may, in the opinion of the investigator, preclude safe administration of the test articles or affect the results of the study.
• Need to wear contact lenses on an extended wear basis (i.e., overnight) during the study.
• Use of products other than a multi-purpose solution or hydrogen peroxide solution, including daily and enzyme cleaners and saline rinses, for lens care at least 7 days prior to Visit 1 (Day 0 - Baseline).
• Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1. Use of lens rewetting drops is acceptable.
• History or current ocular infections or ocular inflammatory events.
• Ocular surgery within the past year.
• Participation in any investigational study within the past 30 days.
• Other protocol-defined exclusion criteria may apply.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Lens Wettability	16 hours	As assessed by the investigator during slit-lamp exam and rated on a 0-4 scale, with 0 = a smooth uniformly reflecting wettable surface; 1 = a coarse hazy wettable surface which seems resolved momentarily with each blink and becomes exacerbated with staring; 2 = one stable dry (non-wetting) area of some magnitude; 3 = more than one stable dry (non-wetting) area of some magnitude; 4 = non-wettable lens surface of severe magnitude. Lenses with a Grade 0 or 1 were rated as wettable and reported as a percentage of total lenses evaluated.

Trial Locations

Locations (1)

Contact Alcon Call Center for Trial Locations; 🇺🇸 Fort Worth, Texas, United States