Effects of Contact Lens Care Regimens on the Corneal Epithelium

NCT00349882 | Completed Phase 4

• 1 other identifier: P/216/05/L
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the performance of two different contact lens care solutions, specifically their affects on the front surface of the eye.

Conditions

Myopia

Outcome Measures

Primary Outcomes (2)

• The primary outcome measure of this study is to investigate the effects of two

• different contact lens care solutions on the cornea.

Secondary Outcomes (2)

• The secondary outcome measure of this study is to compare the subjective and

• objective responses between two different contact lens care solutions.

Interventions

soft contact lens DEVICE

Marketed multipurpose disinfection regimen DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is at least 18 years old 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 6/6 or better (each eye), with their habitual visual correction.
• Has normal binocular vision (no strabismus, no amblyopia, and anisometropia less than or equal to 1.00 D).
• Has clear corneas and no active ocular disease.
• Has had an ocular examination in the last 2 years.
• Has not worn contact lenses before, or has worn contact lenses only for a trial period, with no trials occurring within the last six months.
• An ineligible contact lens wearer is one who:
• Responds positively to points 1 to 7 above.
• Has a distance contact lens prescription between -0.50D and -9.00 D.
• Has astigmatism less than or equal to -1.00D cyl.
• Currently wears silicone hydrogel contact lenses successfully.
• Agrees to wear the study lenses on a daily wear basis without the use of ocular or lens lubricants.

You may not qualify if:

• 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.
• An ineligible contact lens wearer is one who:
• Has known sensitivity to the contact lens care solutions used in the study.
• Has ocular or systemic allergies that could adversely affect contact lens wear.
• Has any ocular pathology or severe insufficiency of lacrimal secretion (dry eyes) that would affect the wearing of contact lenses.
• Has pinguecula/pterygium that in the investigator's judgement makes contact lens wear inadvisable.

Sponsors & Collaborators

• University of Waterloo: lead
• Alcon Research: collaborator

Study Sites (1)

Centre for Contact Lens Research, University of Waterloo

Waterloo, Ontario, N2L 3G1, Canada

Location

MeSH Terms

Conditions

Myopia

Interventions

Contact Lenses, Hydrophilic

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Contact Lenses; Lenses; Optical Devices; Equipment and Supplies

Study Officials

• Craig Woods, PhD

  University of Waterloo

  PRINCIPAL INVESTIGATOR

• Desmond Fonn, MOptom

  University of Waterloo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 10, 2006
• Study Start: June 1, 2005
• Last Updated: July 10, 2006

Record last verified: 2006-07

Locations

CA (1)