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

Phase 4

Completed

• Conditions: Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Interventions: Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD); Drug: sodium hyaluronate 0.18% (VISMED® Multi)

• Registration Number: NCT00987727
• Lead Sponsor: Allergan

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 available

Study Timeline

• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-30
• Study First Posted: 2009-10-01
• Study Start: 2009-11
• Primary Completion: 2010-07
• Study Completion: 2010-09
• Status Verified: 2011-08
• Results First Submitted: 2011-08-17
• Results First Submitted QC: 2011-08-17
• Last Update Submitted: 2011-08-17
• Results First Posted: 2011-09-21
• Last Update Posted: 2011-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)	carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)
2	sodium hyaluronate 0.18% (VISMED® Multi)	sodium hyaluronate 0.18% (VISMED® Multi)

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Global Ocular Staining Score at Day 35	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

Name	Time	Method
Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35	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.