Clinical Performance of a Silicone Hydrogel Lens With Use of FID 114675A

Not Applicable

Completed

• Conditions: Contact Lens Fit; Myopia
• Interventions: Device: FID 114675A multi-purpose disinfecting solution (MPDS); Device: renu fresh Multi-Purpose Solution (MPS); Device: Galyfilcon A contact lenses (Acuvue Advance)

• Registration Number: NCT01240135
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is to evaluate the clinical performance of a silicone hydrogel contact lens when used with an investigational multi-purpose disinfecting solution (MPDS).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-11-10
• Study First Submitted QC: 2010-11-10
• Study First Posted: 2010-11-15
• Primary Completion: 2011-02
• Study Completion: 2011-02
• Status Verified: 2012-06
• Results First Submitted: 2012-06-08
• Results First Submitted QC: 2012-06-08
• Last Update Submitted: 2012-06-08
• Results First Posted: 2012-07-12
• Last Update Posted: 2012-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

Inclusion Criteria

• 18 years of age or older.
• History of at least 5 days successful daily wear (minimum 8 hours per day) of spherical, single power Acuvue® Advance® SiH contact lenses prior to Visit 1.
• Wear contact lenses a minimum of 8 hours per day prior to Visit 1.
• Vision correctable to 20/30 (Snellen) or better in each eye at distance with study lenses at Visit 1.
• Other protocol-defined inclusion criteria may apply.

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Exclusion Criteria

• 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 to care for lenses at least 7 days prior to Visit 1. Pre-study use of rewetting drops is acceptable.
• History of intolerance or known sensitivity to any component of the treatments.
• Use of over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1.
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
renu fresh / FID 114675A	FID 114675A multi-purpose disinfecting solution (MPDS)	Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
renu fresh / FID 114675A	Galyfilcon A contact lenses (Acuvue Advance)	Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
renu fresh / FID 114675A	renu fresh Multi-Purpose Solution (MPS)	Renu fresh used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after FID 114675A used for contact lens care for an additional 14 days.
FID 114576A / renu fresh	FID 114675A multi-purpose disinfecting solution (MPDS)	FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
FID 114576A / renu fresh	renu fresh Multi-Purpose Solution (MPS)	FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.
FID 114576A / renu fresh	Galyfilcon A contact lenses (Acuvue Advance)	FID 114675A used for contact lens care per protocol-specified instructions for 14 days, followed by a minimum 1-day washout period, after which renu fresh used for contact lens care for an additional 14 days.

Primary Outcome Measures

Name	Time	Method
Lens Fit	Day 14 of lens wear	As assessed by the investigator using a composite score based on three lens fit measures: static, push-up, and centration. Static and pushup were assessed on a 5-point scale, where -2=reduced movement unacceptable, -1=reduced movement acceptable, 0=optimal movement, 1=excessive movement acceptable, 2=excessive movement unacceptable. Centration was assessed on a 3-point scale, where 0=optimal lens centration, 1=acceptable decentration, 2=unacceptable decentration. A subject with an assessment of optimal or acceptable for each measure was considered acceptable on all measurements.

Secondary Outcome Measures

Name	Time	Method
Mean Change From Baseline for Circumlimbal Conjunctival Staining Sum Score	Day 14 of lens wear	The bulbar conjunctiva was assessed by the investigator at baseline and Day 14 utilizing a slit-lamp and ophthalmic dye. Staining coverage was scored separately in each of four regions (nasal, temporal, inferior, and superior) using a 5-point photographic reference scale, where 0=0.00% coverage and 4=10% or greater coverage. The scores for the four regions were summed, with a sum score range of 0-16.