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
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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 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 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
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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 |
- 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).
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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
France | |
Paris, France |
Study Director: | Medical Director | Allergan |
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 |
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 |