Corneal and Conjunctival Sensitivity and Staining Study

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to compare subjective symptoms and ocular health in a group of individuals who are currently wearing soft contact lenses on a daily wear basis, after a short period of no lens wear and during the time course when using differing care regimens.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Waterloo
• Collaborator: Alcon Research
• Treatments: Pharmaceutical Solutions

Criteria

Inclusion Criteria:

An eligible participant is one who:

• Is between 17-45 years old and has full legal capacity to volunteer.

• Has read and signed an information consent letter, after having the opportunity to ask questions and receive acceptable answers.

• Is willing and able to follow instructions and maintain the appointment schedule.

• Does not experience any dryness related symptoms during lens wear (i.e. at least 12 hours of comfortable wearing time)

• Is correctable to a visual acuity of 6/7.5 (20/25) or better (each eye) with their habitual vision correction.

• Has normal binocular vision (no strabismus, no amblyopia).

• Has clear corneas and no active ocular disease.

• Has had an ocular examination in the last two years. Has a distance contact lens prescription between +0.50D to +6.00 DS and -0.50D and -12.00 DS.

• Has astigmatism less than or equal to -1.00DC.

• Agrees to wear the study lenses on a daily wear basis.

• Has a pair of glasses with updated prescription and agrees to wear them during the period no lens wear (7-10 days) as required by the study.

Exclusion Criteria:

A person is ineligible if he/she:

• 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 a 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.

• Has a known clinically significant sensitivity to the contact lens care solutions used in the study.

• Has ocular or systemic allergies that could adversely affect contact lens wear.

• Currently wears lenses on a continuous or extended wear basis.

• 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 judgment, makes contact lens wear inadvisable.

• Is a rigid lens wearer.

• Has corneal staining graded as 2 (macropunctate) or greater in any corneal region in either eye, sum of corneal staining type (severity) of greater than or equal to 4 across the entire cornea in either eye, or any corneal staining covering greater than or equal to 20% in any corneal region in either eye.