A Dispensing Clinical Trial of a Study Test Silicone Hydrogel Lens Against Control Lens Over 1 Week

Coopervision, Inc.1 site in 1 country41 target enrollmentJuly 2015

ConditionsMyopia

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Myopia
Sponsor: Coopervision, Inc.
Enrollment: 41
Locations: 1
Primary Endpoint: Comfort
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a 1-week dispensing, double-masked, randomized, bilateral study comparing the test lens against the control lens.

Detailed Description

The order of lens wear (test lens first, control lens second or control lens first, test lens second) will be selected according to a randomization table. Both test and control lenses will be used in a daily wear modality for 1 week. It is anticipated that this study will involve following visits: Baseline (screening and dispense of 1st study pair of lenses, visit combined), 1-week visit (follow-up of the 1st study pair of lenses and dispense the 2nd study pair of lenses) and 2-week visit (1 week follow-up of the 2nd study pair of lenses).

Registry

clinicaltrials.gov

Start Date

July 2015

End Date

September 2015

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Coopervision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

•A person will be excluded from the study if he/she:
•Is participating in any concurrent clinical or research study
•Has any known active\* ocular disease and/or infection
•Has a systemic condition that in the opinion of the investigator may affect a study outcome variable\*\*
•Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
•Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
•Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit).
•Is aphakic
•Has undergone corneal refractive surgery.
•For the purposes of this study, active\* ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active. Participants will be excluded with significant slit lamp findings (e.g. infiltrates or other slit lamp findings Grade 3 or above: corneal edema, tarsal abnormalities, and conjunctival injection) or active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology)

Outcomes

Primary Outcomes

Comfort

Time Frame: Baseline and 1 week

Subjective ratings scale (0-100) assessed: 0=Cannot be worn, causes pain, 20=Frequently irritating, 40=Occasionally irritating, 60=Occasionally noticable but not irritating, 80=Rarely noticeable, 100=Cannot be felt ever. Time points for comfort: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.

Dryness

Time Frame: Baseline and 1 week

Subjective ratings scale (0-100): 0=Cannot be worn, extremely dry, 20=Frequently Irritating, 40=Occasionally irritating, 60=Occasionally noticeable but not irritating, 80=Rarely noticeable, 100=No dryness experienced at any time. Time points for dryness: lens dispense at baseline, lens insertion at 1 week, and overall at 1 week.