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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00691197
First Posted: June 5, 2008
Last Update Posted: July 22, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Allergan
  Purpose
Testing the Safety and Acceptability of Using a Rewetting Drop with Contact Lenses

Condition Intervention Phase
Ametropia Device: Carboxymethylcellulose sodium and Glycerin Device: Carboxymethylcellulose sodium Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety and Acceptability of Using a Rewetting Drop With Contact Lens Wear

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: 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:
  • Corneal Staining [ Time Frame: 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


Enrollment: 246
Study Start Date: March 2008
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Carboxymethylcellulose sodium and Glycerin
Carboxymethylcellulose sodium and Glycerin based rewetting drop
Device: Carboxymethylcellulose sodium and Glycerin
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Other Name: Optive™
Active Comparator: Carboxymethylcellulose sodium
Carboxymethylcellulose sodium based rewetting drop
Device: Carboxymethylcellulose sodium
Eye drops used at least 4 times per day, 1-2 drops in each eye while wearing contact lenses.
Other Name: Refresh Contacts®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adapted contact lens wearer

Exclusion Criteria:

  • Monovision lens wearer, ocular or systemic disease, pregnant or planning to become pregnant
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00691197


Locations
United States, California
San Diego, California, United States
Sponsors and Collaborators
Allergan
Investigators
Study Chair: Medical Director Allergan
  More Information

Responsible Party: Therapeutic Area Head, Allergan
ClinicalTrials.gov Identifier: NCT00691197     History of Changes
Other Study ID Numbers: AG9689-002
First Submitted: March 4, 2008
First Posted: June 5, 2008
Results First Submitted: November 6, 2009
Results First Posted: December 10, 2009
Last Update Posted: July 22, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases
Glycerol
Carboxymethylcellulose Sodium
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Laxatives
Gastrointestinal Agents