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

This study has been completed.
Sponsor:
Information provided by:
Allergan
ClinicalTrials.gov Identifier:
NCT00987727
First received: September 29, 2009
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Dry Eye Syndromes
Keratoconjunctivitis Sicca
 Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
Drug: sodium hyaluronate 0.18% (VISMED® Multi)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Allergan:

Primary Outcome Measures:
  • Change From Baseline in Global Ocular Staining Score at Day 35 [ Time Frame: Baseline, Day 35 ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35 [ Time Frame: Baseline, Day 35 ] [ Designated as safety issue: No ]
    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.


Enrollment: 82
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
 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
Active Comparator: 2
sodium hyaluronate 0.18% (VISMED® Multi)
 Drug: sodium hyaluronate 0.18% (VISMED® Multi)
One drop in each eye three to six times daily, as needed
Other Name: VISMED® Multi

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00987727

Locations
France
Paris, France
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

No publications provided

Responsible Party: Vice President Medical Affairs, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00987727     History of Changes
Other Study ID Numbers: MAF-AGN-OPH-DE-011
Study First Received: September 29, 2009
Results First Received: August 17, 2011
Last Updated: August 17, 2011
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Dry Eye Syndromes
Keratoconjunctivitis Sicca
Keratoconjunctivitis
Lacrimal Apparatus Diseases
Eye Diseases
Conjunctivitis
Conjunctival Diseases
Keratitis
Corneal Diseases
Carboxymethylcellulose Sodium
Glycerol
 Hyaluronic Acid
Laxatives
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Cryoprotective Agents
Protective Agents
Physiological Effects of Drugs
Adjuvants, Immunologic
Immunologic Factors

ClinicalTrials.gov processed this record on May 16, 2013