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

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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:
Information provided by:
Allergan

Study Description
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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.

Condition or disease Intervention/treatment 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 82 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
Study Start Date : November 2009
Actual Primary Completion Date : July 2010
Actual Study Completion Date : September 2010

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Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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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): NCT00987727


Locations
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France
Paris, France
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Medical Director Allergan
More Information
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Responsible Party: Vice President Medical Affairs, Allergan, Inc.
ClinicalTrials.gov Identifier: NCT00987727    
Other Study ID Numbers: MAF-AGN-OPH-DE-011
First Posted: October 1, 2009    Key Record Dates
Results First Posted: September 21, 2011
Last Update Posted: September 21, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Carboxymethylcellulose Sodium
 Hyaluronic Acid
Glycerol
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents
Laxatives
Gastrointestinal Agents
Cryoprotective Agents