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

Alcon

Status: Completed

Conditions: Myopia; Contact Lens Fit

Treatments: Device: Galyfilcon A contact lenses (Acuvue Advance); Device: FID 114675A multi-purpose disinfecting solution (MPDS); Device: renu fresh Multi-Purpose Solution (MPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01240135

C-10-030

Details and patient eligibility

About

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).

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Triple Blind

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89 participants in 2 patient groups

FID 114576A / renu fresh

Other group

Description:

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.

Treatment:

Device: renu fresh Multi-Purpose Solution (MPS)

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

Device: Galyfilcon A contact lenses (Acuvue Advance)

renu fresh / FID 114675A

Other group

Description:

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.

Treatment:

Device: renu fresh Multi-Purpose Solution (MPS)

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

Device: Galyfilcon A contact lenses (Acuvue Advance)