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: June 26, 2015
Last verified: June 2015
  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:


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 ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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: June 26, 2015
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 21, 2016