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

NCT ID: NCT01294917

Last Updated: 2017-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-02-28
• Study Completion Date: 2011-08-31

Brief Summary

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

Detailed 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.

Conditions

Normal Contact Lens Wearers

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Investigational MPS

AMO Investigational MPS.

Group Type: EXPERIMENTAL

Multi-purpose disinfecting solution

Intervention Type: DEVICE

For the cleaning, rinsing, and storage of soft contact lenses.

Clear Care

Peroxide-based lens care regimen.

Group Type: ACTIVE_COMPARATOR

Clear Care

Intervention Type: DEVICE

Peroxide-based regimen for cleaning and disinfecting soft contact lenses.

Opti-Free RepleniSH

Multi-purpose disinfecting solution (Alcon).

Group Type: ACTIVE_COMPARATOR

Opti-Free RepleniSH

Intervention Type: DEVICE

Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses.

Interventions

Multi-purpose disinfecting solution

For the cleaning, rinsing, and storage of soft contact lenses.

Intervention Type: DEVICE

Clear Care

Peroxide-based regimen for cleaning and disinfecting soft contact lenses.

Intervention Type: DEVICE

Opti-Free RepleniSH

Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Medical Optics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Craig Woods, MOptom

Role: PRINCIPAL_INVESTIGATOR

University of Waterloo

Locations

Centre for Contact Lens Research

Waterloo, Ontario, Canada

Countries

Canada

Other Identifiers

COBR-305-9608

Identifier Type: -

Identifier Source: org_study_id