Evaluation of Disinfecting Solutions and Protein Remover With a Silicone Hydrogel Lens

University of Waterloo

Status: Completed

Conditions: Ametropia

Treatments: Drug: Alcon Opti-Free® RepleniSH®; Drug: B&L ReNu MultiPlus™; Drug: Alcon Opti-Free® RepleniSH® with Supraclens®

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00754338

P/279/07/L

Details and patient eligibility

About

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format.

Full description

The purpose of this study is to determine if reduced lens deposits and increased comfort can be achieved by using Multipurpose disinfecting solutions (MPDS) in a no-rub format but in conjunction with an intensive cleaner, rather than using MPDS in a rub format by observing changes within the cornea and collecting subjective ratings.

Enrollment: 76 patients

Sex: All

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Is at least 17 years of age and has full legal capacity to volunteer.
• Has read, understood and signed an information consent letter.
• Is willing and able to follow instructions and maintain the appointment schedule.
• Is correctable to a visual acuity of 6/9 or better (in each eye) with their habitual vision correction.
• Has clear corneas and no active ocular disease.
• Has had an ocular examination in the last two years.
• Is a current soft lens wearer, replacing their lenses every two weeks to one month.
• Has a distance contact lens prescription between +6.00D to -10.00 DS and can be successfully fit with the study lens.
• Has astigmatism less than or equal to -1.00 DC.

Exclusion criteria

• Has any signs or symptoms of dry eye.
• Has any clinically significant blepharitis.
• Has undergone corneal refractive surgery.
• Is aphakic.
• Has any active ocular disease.
• Has any systemic disease affecting ocular health.
• Is using any systemic or topical medications that may affect ocular health.
• Has known sensitivity to the diagnostic pharmaceuticals to be used in the study.
• Is pregnant or lactating.
• Is participating in any other type of clinical or research study.
• Currently wears daily disposable lenses.
• Currently wears lenses on an extended wear basis.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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76 participants in 4 patient groups

Phase1 - Arm 1

Active Comparator group

Treatment:

Drug: Alcon Opti-Free® RepleniSH®

Drug: Alcon Opti-Free® RepleniSH® with Supraclens®

Phase1 - Arm 2

Active Comparator group

Treatment:

Drug: Alcon Opti-Free® RepleniSH®

Drug: Alcon Opti-Free® RepleniSH® with Supraclens®

Phase 2 - Arm 1

Active Comparator group

Treatment:

Drug: Alcon Opti-Free® RepleniSH® with Supraclens®

Drug: B&L ReNu MultiPlus™

Phase 2 - Arm 2

Active Comparator group

Treatment:

Drug: Alcon Opti-Free® RepleniSH® with Supraclens®

Drug: B&L ReNu MultiPlus™