Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms

NCT00938704 | Completed Phase 4 Results

• 1 other identifier: MA-OPT-09-002
• Study Type: interventional
• Target: 71
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of two non-preserved artificial tears, (carboxymethylcellulose 0.5%, + glycerin 0.9% vs. sodium hyaluronate 0.18%) eye drops for the treatment of the signs and symptoms of dry eye disease.

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2

  Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement.

  Baseline, Week 2

Secondary Outcomes (4)

• Change From Baseline in Tear Breakup Time (TBUT) at Week 2

  Baseline, Week 2

• Change From Baseline in Corneal Staining at Week 2

  Baseline, Week 2

• Change From Baseline in Conjunctival Staining (Temporal) at Week 2

  Baseline, Week 2

• Change From Baseline in Conjunctival Staining (Nasal) at Week 2

  Baseline, Week 2

Study Arms (2)

1

ACTIVE COMPARATOR

carboxymethylcellulose 0.5%, glycerin 0.9%

Drug: carboxymethylcellulose 0.5% +glycerin 0.9%

2

ACTIVE COMPARATOR

sodium hyaluronate 0.18%

Drug: sodium hyaluronate 0.18%

Interventions

carboxymethylcellulose 0.5% +glycerin 0.9% DRUG

To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.

Also known as: Optive™ Sensitive

1

sodium hyaluronate 0.18% DRUG

To open, twist and pull tab to remove. Instill study medication as needed, but at least one drop 3 times a day as instructed in the protocol and then discard the container.

Also known as: Vismed®

2

Eligibility Criteria

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

You may qualify if:

• Current use of an artificial tear product at least 2 times per day (e.g. for relief of dry eye symptoms of dryness).
• Be likely to complete the entire course of study and to comply with appropriate instructions

You may not qualify if:

• Have undergone refractive surgery (e.g., cataract surgery, PRK, LASIK, or any surgery involving a limbal or corneal incision) within the last 12 months.
• Have uncontrolled systemic disease
• Are currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
• Have anticipated contact lens wear during the study
• Have an active ocular infection

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Unknown Facility

Ulm, Germany

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates

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: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2009
• First Posted: July 14, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 31, 2011
• Results First Posted: October 31, 2011

Record last verified: 2011-09

Locations

DE (1)