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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00691197
First received: March 4, 2008
Last updated: November 6, 2009
Last verified: November 2009
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Eye Wear
U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Best Corrected Visual Acuity [ Time Frame: Change from Baseline at Day 90 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Corneal Staining [ Time Frame: Day 90 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00691197

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

No publications provided

Responsible Party: Therapeutic Area Head, Allergan
ClinicalTrials.gov Identifier: NCT00691197     History of Changes
Other Study ID Numbers: AG9689-002
Study First Received: March 4, 2008
Results First Received: November 6, 2009
Last Updated: November 6, 2009
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on June 18, 2013