Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

• ClinicalTrials.gov Identifier: NCT00987727
• Recruitment Status: Completed
• First Posted: October 1, 2009
• Results First Posted: September 21, 2011
• Last Update Posted: September 21, 2011
• Sponsor: Allergan
• Information provided by: Allergan

Tracking Information

• First Submitted Date: September 29, 2009
• First Posted Date: October 1, 2009
• Results First Submitted Date: August 17, 2011
• Results First Posted Date: September 21, 2011
• Last Update Posted Date: September 21, 2011
• Study Start Date: November 2009
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 17, 2011)

Change From Baseline in Global Ocular Staining Score at Day 35 [ Time Frame: Baseline, Day 35 ]

Change from baseline in global ocular staining score (range from 0-15) at Day 35. The global ocular staining score is the sum of three different staining severities, each with a score of 0-5 on a 6-point scale, where 0 is no staining (best) and 5 is diffuse staining (worst).

• Original Primary Outcome Measures (submitted: September 30, 2009): Global Ocular Staining [ Time Frame: Day 35 ]

Current Secondary Outcome Measures (submitted: August 17, 2011)

Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 [ Time Frame: Baseline, Day 35 ]

Change from baseline in Ocular Surface Disease Index (OSDI) questionnaire score at Day 35. The OSDI questionnaire consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (where 0=none of the time and 4=all of the time). The score is converted to a 0-100 point score where 0 is no symptoms and 100 is most symptoms.

• Original Secondary Outcome Measures (submitted: September 30, 2009): OSDI score [ Time Frame: Day 35 ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
• Official Title: Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
• Brief Summary: This study will evaluate the safety and efficacy of OPTIVE® MD for ocular surface integrity in symptomatic dry eye condition in absence of obvious eye-lid inflammation.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment

Condition

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

• Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
  One drop in each eye three to six times daily, as needed
  Other Name: OPTIVE® MD
• Drug: sodium hyaluronate 0.18% (VISMED® Multi)
  One drop in each eye three to six times daily, as needed
  Other Name: VISMED® Multi

Study Arms

• Experimental: 1
  carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
  Intervention: Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
• Active Comparator: 2
  sodium hyaluronate 0.18% (VISMED® Multi)
  Intervention: Drug: sodium hyaluronate 0.18% (VISMED® Multi)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 17, 2011): 82
• Original Estimated Enrollment (submitted: September 30, 2009): 80
• Actual Study Completion Date: September 2010
• Actual Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Have been using artificial tears for at least 3 months prior to study inclusion
• Have been using preservative free artificial tears at least three times daily (TIB) for at least 2 weeks immediately prior to study inclusion
• Having moderate to severe symptoms suggestive of dry eye

Exclusion Criteria:

• Current enrollment in an investigational drug or device study or participation in such a study within 3 months prior to entry into this study
• Moderate to severe blepharitis
• History or active signs of ocular trauma, ocular infection, or ocular inflammation within the last 3 months
• History or active signs of ocular allergic disease or ocular herpes within the last year
• History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: France

Administrative Information

• NCT Number: NCT00987727
• Other Study ID Numbers: MAF-AGN-OPH-DE-011
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Vice President Medical Affairs, Allergan, Inc.
• Study Sponsor: Allergan
• Collaborators: Not Provided

Investigators

• Study Director: Medical Director; Allergan

• PRS Account: Allergan
• Verification Date: August 2011