Back to resultsSafety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
Primary Purpose
Dry Eye Syndromes, Keratoconjunctivitis Sicca
Status
Completed
Phase
Phase 4
Locations
France
Study Type
Interventional
Intervention
carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
sodium hyaluronate 0.18% (VISMED® Multi)
Sponsored by
About this trial
This is an interventional treatment trial for Dry Eye Syndromes
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
sodium hyaluronate 0.18% (VISMED® Multi)
Outcomes
Primary Outcome Measures
Change From Baseline in Global Ocular Staining Score at 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
Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at 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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00987727
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Allergan
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes, Keratoconjunctivitis Sicca
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
Arm Title
2
Arm Type
Active Comparator
Arm Description
sodium hyaluronate 0.18% (VISMED® Multi)
Intervention Type
Drug
Intervention Name(s)
carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)
Other Intervention Name(s)
OPTIVE® MD
Intervention Description
One drop in each eye three to six times daily, as needed
Intervention Type
Drug
Intervention Name(s)
sodium hyaluronate 0.18% (VISMED® Multi)
Other Intervention Name(s)
VISMED® Multi
Intervention Description
One drop in each eye three to six times daily, as needed
Primary Outcome Measure Information:
Title
Change From Baseline in Global Ocular Staining Score at Day 35
Description
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).
Time Frame
Baseline, Day 35
Secondary Outcome Measure Information:
Title
Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35
Description
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.
Time Frame
Baseline, Day 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
City
Paris
Country
France
12. IPD Sharing Statement
Learn more about this trial
Safety and Efficacy of Carboxymethylcellulose for Ocular Surface Integrity in Symptomatic Dry Eye
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