Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear

Phase 2

Completed

• Conditions: Ametropia
• Interventions: Device: Carboxymethylcellulose sodium; Device: Carboxymethylcellulose sodium and Glycerin

• Registration Number: NCT00691197
• Lead Sponsor: Allergan

Brief Summary

Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2008-03-04
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-11-06
• Results First Submitted QC: 2009-11-06
• Results First Posted: 2009-12-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-26
• Last Update Posted: 2015-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 246

Inclusion Criteria

• Adapted contact lens wearer

Exclusion Criteria

• Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Carboxymethylcellulose sodium	Carboxymethylcellulose sodium	Carboxymethylcellulose sodium based rewetting drop
Carboxymethylcellulose sodium and Glycerin	Carboxymethylcellulose sodium and Glycerin	Carboxymethylcellulose sodium and Glycerin based rewetting drop

Primary Outcome Measures

Name	Time	Method
Best Corrected Visual Acuity	Change from Baseline at Day 90	Percentage of Subjects Tabulated by Changes in Line Number at Day 90 from Baseline; Visual Acuity measured by LogMar reported as Snellen equivalents. Better: an increase of 2 lines or more in at least one eye; No Change: a change less than +/- 2 lines in both eyes; Worse: a decrease of 2 lines or more in at least one eye.

Secondary Outcome Measures

Name	Time	Method
Corneal Staining	Day 90	Corneal staining of greater or equal to grade 2 at day 90. Grading scale: 0 = None Present; 1 = Trace Finding; 2 = Mild Finding; 3 = Moderate Finding; 4 = Severe Finding