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

Comparison of a New AMO MPS to Existing Contact Lens Regimens

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

Study Overview

• Status: Completed
• Conditions: Normal Contact Lens Wearers
• Intervention / Treatment: Device: Multi-purpose disinfecting solution; Device: Clear Care; Device: Opti-Free RepleniSH

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Waterloo, Ontario, Canada, N2L 3G1
      • Centre for Contact Lens Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Investigational MPS; AMO Investigational MPS.	Device: Multi-purpose disinfecting solution; For the cleaning, rinsing, and storage of soft contact lenses.
Active Comparator: Clear Care; Peroxide-based lens care regimen.	Device: Clear Care; Peroxide-based regimen for cleaning and disinfecting soft contact lenses.
Active Comparator: Opti-Free RepleniSH; Multi-purpose disinfecting solution (Alcon).	Device: Opti-Free RepleniSH; Multi-purpose disinfecting solution for the cleaning, rinsing and storing of soft contact lenses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Staining	Corneal staining will be assessed with sodium fluorescein dye on the ocular surface. The cornea is split into 5 sections, each section is evaluated by staining type, depth, and extent is graded on a 0 to 100 scale with higher scores indicating more staining. The possible total range for the total score per eye is 0 to 50,000 (100x100x100=10,000 per section) with values higher than 1200 being clinically relevant.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Lens Wearing Comfort	This will be assessed by a questionnaire on patient-perceived lens comfort and any symptoms of discomfort on a 0 to 100 scale.	4 weeks
Dryness	This will be assessed by the tear break-up time on the lens surface, measured in seconds.	4 weeks

Collaborators and Investigators

• Sponsor: Abbott Medical Optics
• Investigators: Principal Investigator: Craig Woods, MOptom, University of Waterloo

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: February 10, 2011
• First Submitted That Met QC Criteria: February 10, 2011
• First Posted (Estimate): February 14, 2011

Study Record Updates

• Last Update Posted (Actual): March 6, 2017
• Last Update Submitted That Met QC Criteria: January 20, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: COBR-305-9608