Effect of FID 114675A on Lens Wettability

Not Applicable

Completed

• Conditions: Contact Lens Wettability
• Interventions: Device: FID 114675A multi-purpose disinfecting solution (MPDS); Device: Blister pack solution; Device: Soft contact lens

• 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blister Pack	Blister pack solution	Contact lens removed directly from the blister pack randomly assigned to one eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours.
FID 114675A	FID 114675A multi-purpose disinfecting solution (MPDS)	Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to one eye, with contact lens removed directly from the blister pack assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours.
FID 114675A	Soft contact lens	Contact lens soaked overnight in an investigational multi-purpose disinfecting solution randomly assigned to one eye, with contact lens removed directly from the blister pack assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours.
Blister Pack	Soft contact lens	Contact lens removed directly from the blister pack randomly assigned to one eye, with contact lens soaked overnight in an investigational multi-purpose disinfecting solution assigned to the fellow eye for contralateral wear. Both products worn for one day, 16 hours.

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