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

NCT00987727 | Completed Phase 4 Results

• 1 other identifier: MAF-AGN-OPH-DE-011
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, Day 35

Secondary Outcomes (1)

• Change From Baseline in Ocular Surface Disease Index (OSDI) Questionnaire Score at Day 35

  Baseline, Day 35

Study Arms (2)

1

EXPERIMENTAL

carboxymethylcellulose 0.5% and glycerin 0.9% (OPTIVE® MD)

Drug: carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD)

2

ACTIVE COMPARATOR

sodium hyaluronate 0.18% (VISMED® Multi)

Drug: sodium hyaluronate 0.18% (VISMED® Multi)

Interventions

carboxymethylcellulose 0.5% , glycerin 0.9% (OPTIVE® MD) DRUG

One drop in each eye three to six times daily, as needed

Also known as: OPTIVE® MD

1

sodium hyaluronate 0.18% (VISMED® Multi) DRUG

One drop in each eye three to six times daily, as needed

Also known as: VISMED® Multi

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Having moderate to severe symptoms suggestive of dry eye

You may not qualify if:

• 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.

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Paris, France

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Keratoconjunctivitis Sicca

Interventions

Carboxymethylcellulose Sodium; Glycerol; Hyaluronic Acid

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases

Intervention Hierarchy (Ancestors)

Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates; Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Glycosaminoglycans

Results Point of Contact

• Title: Vice President Medical Affairs
• Organization: Allergan, Inc

clinicaltrials@allergan.com

714-246-4500

Study Officials

• Medical Director

  Allergan

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 29, 2009
• First Posted: October 1, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2010
• Study Completion: September 1, 2010
• Last Updated: September 21, 2011
• Results First Posted: September 21, 2011

Record last verified: 2011-08

Locations

FR (1)