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

NCT01294917 | Completed Results

• 1 other identifier: COBR-305-9608
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Normal Contact Lens Wearers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Subjective Lens Wearing Comfort

  4 weeks

• Dryness

  4 weeks

Study Arms (3)

Investigational MPS

EXPERIMENTAL

AMO Investigational MPS.

Device: Multi-purpose disinfecting solution

Clear Care

ACTIVE COMPARATOR

Peroxide-based lens care regimen.

Device: Clear Care

Opti-Free RepleniSH

ACTIVE COMPARATOR

Multi-purpose disinfecting solution (Alcon).

Device: Opti-Free RepleniSH

Interventions

Multi-purpose disinfecting solution DEVICE

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

Investigational MPS

Clear Care DEVICE

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

Clear Care

Opti-Free RepleniSH DEVICE

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

Opti-Free RepleniSH

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Abbott Medical Optics: lead

Study Sites (1)

Centre for Contact Lens Research

Waterloo, Ontario, N2L 3G1, Canada

Location

Results Point of Contact

• Title: Clinical Scientist
• Organization: Centre for Contact Lens Research

marc.schulze@uwaterloo.ca

519-888-4567

Study Officials

• Craig Woods, MOptom

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2011
• First Posted: February 14, 2011
• Study Start: February 1, 2011
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: March 6, 2017
• Results First Posted: May 14, 2012

Record last verified: 2017-01

Locations

CA (1)