Comparison of a New Abbott Medical Optics (AMO) Multi-Purpose Solution (MPS) to Existing Contact Lens Regimens

Abbott

Status: Completed

Conditions: Normal Contact Lens Wearers

Treatments: Device: Clear Care; Device: Multi-purpose disinfecting solution; Device: Opti-Free RepleniSH

Study type: Interventional

Funder types: Industry

Identifiers

NCT01294917

COBR-305-9608

Details and patient eligibility

About

Crossover clinical evaluation three contact lens care regimens used for one month with Acuvue Oasys lenses.

Full description

This is a three-arm crossover clinical evaluation of 40 subjects who will use each of three contact lens care regimens for one month with Acuvue Oasys lenses. The subjects will be randomized on the order of solutions used: Investigational MPS, ClearCare, and Opti-Free RepleniSH MPS.

Enrollment: 40 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 and signed an information consent letter;
• Is willing and able to follow instructions and maintain the appointment schedule;
• Has had an ocular examination in the last two years;
• Is a current soft lens wearer using either two-week or monthly replacement lenses;
• Is correctable to a visual acuity of 6/7.5 (20/25) or better (both eyes) with their habitual vision correction (either spectacles or contact lenses);
• Has normal binocular vision (no strabismus, no amblyopia);
• Has clear corneas and no active ocular disease;
• Has a distance contact lens prescription between +8.00 diopters (D) to -12.00 D and a successful fit with the study lenses;
• Has astigmatism less than or equal to -1.00 D;
• Agrees to wear the study lenses on a daily wear basis.

Exclusion criteria

• Has any active ocular disease;
• Has any clinically significant lid, conjunctival, or corneal abnormalities that may affect a study outcome variable;
• Has undergone corneal refractive surgery;
• Has a systemic condition that may affect a study outcome variable;
• 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 clinical or research study that may affect a study outcome variable;
• Currently wears daily disposable lenses or extended wear lenses.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 3 patient groups

Investigational MPS

Experimental group

Description:

AMO Investigational MPS.

Treatment:

Device: Multi-purpose disinfecting solution

Clear Care

Active Comparator group

Description:

Peroxide-based lens care regimen.

Treatment:

Device: Clear Care

Opti-Free RepleniSH

Active Comparator group

Description:

Multi-purpose disinfecting solution (Alcon).

Treatment:

Device: Opti-Free RepleniSH