Clinical trial NCT01912768: Safety and Efficacy Evaluation of a New Contact Lens Disinfecting Solution in Soft Contact Lens Wearers
Official title: Clinical Evaluation of the Safety and Efficacy of FID 120947A Compared to a Marketed Lens Care Solution
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Astigmatism
Hyperopia
Refractive Error
Keywords: contact lenses
contact lens solution
soft contact lenses
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-07-31
Enrollment: 362
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

Eligibility criteria: 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.

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.

Primary outcomes:
measure: Percentage of Subjects With Visibly Clean Lenses
timeFrame: Day 7, Day 30, Day 60, Day 90
measure: Percentage of Subjects With Crystalline Deposits by Type
timeFrame: Day 7, Day 30, Day 60, Day 90
measure: Percentage of Subjects With Film Deposits by Type
timeFrame: Day 7, Day 30, Day 60, Day 90
measure: Average Residual Lens Lysozyme
timeFrame: Day 30/Early Exit
measure: Percentage of Subjects With Change From Baseline in Contact Lens-Corrected Distance Visual Acuity (CLCDVA) by Line Change
timeFrame: Baseline (Day 0), Day 7, Day 30, Day 60, Day 90
measure: Average Lens Wear Time
timeFrame: Day 7, Day 30, Day 60, Day 90
measure: Number of Unscheduled Lens Replacements by Reason
timeFrame: Up to Day 90
measure: Likert Item - "When I Use This Solution, my Lenses Are Comfortable All Day."
timeFrame: Day 7, Day 30, Day 60, Day 90
measure: Likert Item - "When I Use This Solution, at the End of the Lens Wearing Day my Vision is Clear."
timeFrame: Day 7, Day 30, Day 60, Day 90
measure: Likert Item - "When I Use This Solution, I Like the Way This Product Feels During Handling."
timeFrame: Day 7, Day 30, Day 60, Day 90
measure: Crystalline Deposit Area Covered
timeFrame: Day 7, Day 30, Day 60, Day 90
measure: Film Deposit Area Covered
timeFrame: Day 7, Day 30, Day 60, Day 90
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Monica Studzinski, Lead CSM
role: STUDY_DIRECTOR
References: