Effect of FID 114675A on Lens Wettability

Alcon

Status: Completed

Conditions: Contact Lens Wettability

Treatments: Device: Blister pack solution; Device: Soft contact lens; Device: FID 114675A multi-purpose disinfecting solution (MPDS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01342107

C-10-024

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Double Blind

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66 participants in 2 patient groups

FID 114675A

Experimental group

Description:

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.

Treatment:

Device: FID 114675A multi-purpose disinfecting solution (MPDS)

Device: Soft contact lens

Blister Pack

Active Comparator group

Description:

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.

Treatment:

Device: Soft contact lens

Device: Blister pack solution