Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers

Not Applicable

Completed

• Conditions: Refractive Error; Myopia; Astigmatism; Hyperopia
• Interventions: Device: renu fresh multi-purpose solution; Device: FID 120947A contact lens disinfecting solution; Device: Soft contact lenses

• Registration Number: NCT01912768
• Lead Sponsor: Alcon Research

Brief Summary

The purpose of this study is demonstrate substantial equivalence of an investigational contact lens disinfecting solution to a commercially available contact lens solution in silicone hydrogel and soft contact lens wearers.

Detailed Description

Subjects with normal eyes (other than correction for refractive error) successfully wearing soft contact lenses were randomized 2:1 to receive either the investigational or commercial contact lens solution for daily use throughout the study (90 days).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2013-07-29
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Study Start: 2013-12
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Results First Submitted: 2015-05-26
• Results First Submitted QC: 2015-05-26
• Status Verified: 2015-06
• Results First Posted: 2015-06-09
• Last Update Submitted: 2015-06-10
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 362

Inclusion Criteria

• Normal eyes (other than correction for visual acuity);
• Successful history of silicone hydrogel or soft contact lens wear in both eyes in one of the following brands: Soflens® 38, Proclear DW, Frequency 55, Acuvue® Oasys™, Air Optix Aqua, O2 OPTIX, Air Optix for Astigmatism, Air Optix Aqua Multifocal, Biofinity®, PureVision®, PureVision®2;
• Best spectacle corrected distance visual acuity greater than or equal to 20/25 in each eye;
• 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 investigational products or affect the results of this study;
• Need to wear contact lenses on an extended wear basis (ie, overnight) during the study;
• Use of a daily cleaner and/or an enzyme cleaner to care for lenses at least 7 days prior to Visit 1;
• History of intolerance or hypersensitivity to any component of the investigational products;
• Use of all over-the-counter (OTC) or prescribed topical ocular medications within 7 days prior to Visit 1;
• Moderate, severe, abnormal, or other ocular findings;
• Current or history of ocular infection, severe inflammation, or disease within 6 months prior to Visit 1;
• Any systemic disease at Visit 1 (including allergies, respiratory infections or colds) that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions;
• Use of systemic medications that may contribute to adverse ocular effects unless on a stable dosing regimen;
• Ocular surgery within the last 12 months;
• Other protocol-defined exclusion criteria may apply.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
renu fresh	renu fresh multi-purpose solution	Renu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days
FID 120947A	FID 120947A contact lens disinfecting solution	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
FID 120947A	Soft contact lenses	FID 120947A contact lens disinfecting solution used with soft contact lenses (study lenses) on a daily basis for 90 days
renu fresh	Soft contact lenses	Renu fresh multi-purpose solution used with soft contact lenses (study lenses) on a daily basis for 90 days

Primary Outcome Measures

Name	Time	Method
Percentage of Subjects With Film Deposits by Type	Day 7, Day 30, Day 60, Day 90	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change	Baseline (Day 0), Day 7, Day 30, Day 60, Day 90	Distance VA was assessed for each eye individually while reading a chart distant to the participant in dimmed room illumination. VA was measured using a Snellen chart, with 20/20 Snellen acuity considered normal distance-eyesight. A line increase indicates an improvement in VA. One eye (study eye) contributed to the analysis.
Average Lens Wear Time	Day 7, Day 30, Day 60, Day 90	Subject recorded a response to the question, "Averaging over the last 3 days, how many hours per day did you wear your contact lenses?" Lens wear time was measured in hours.
Number of Unscheduled Lens Replacements by Reason	Up to Day 90	A fresh pair of lenses was dispensed on Day 0, Day 30, and Day 60. Lenses replaced at other times were considered unscheduled. The counts in the table represent the total number of unscheduled lenses replaced by reason for any eye, any subject.
Percentage of Subjects With Visibly Clean Lenses	Day 7, Day 30, Day 60, Day 90	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. A lens was considered visibly clean if it had nondetectable films or deposits. One eye (study eye) contributed to the analysis.
Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."	Day 7, Day 30, Day 60, Day 90	Lens comfort was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Film Deposit Area Covered	Day 7, Day 30, Day 60, Day 90	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.
Percentage of Subjects With Crystalline Deposits by Type	Day 7, Day 30, Day 60, Day 90	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered: Type II = films or deposits visible only under special conditions, such as special illumination using an eyepiece of 7-10 times magnification, Type III = films or deposits readily visible on a dry lens under room lighting, with unaided eye, and Type IV = films or deposits obvious under room lighting, with unaided eye, when the lens is wet or dry. One eye (study eye) contributed to the analysis.
Average Residual Lens Lysozyme	Day 30/Early Exit	Worn study lenses were removed and analyzed by high performance liquid chromatography (HPLC) for residual lens lysozyme (protein). Values reported as lower than the limit of quantitation or none detected were imputed as 0.5 μg or 0 μg, respectively. A lower value indicates less lysozyme deposition. One eye (study eye) contributed to the analysis.
Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."	Day 7, Day 30, Day 60, Day 90	Clear vision was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."	Day 7, Day 30, Day 60, Day 90	Product handling was assessed by the subject as a single response on a 5-point Likert scale (Strongly Agree, Agree, Undecided, Disagree, Strongly Disagree) to best describe their lens wearing experience over the last 3 days. Responses were summarized by agreement category and presented as percentage of subjects.
Crystalline Deposit Area Covered	Day 7, Day 30, Day 60, Day 90	Worn study lenses were removed and evaluated for deposits. Deposits found on the lenses were defined using a 3-part classification system consisting of general visibility, the specific appearance and area covered. Values were reported as a percentage of lens area covered. One eye (study eye) contributed to the analysis.