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

Phase 4

Completed

• Conditions: Dry Eye Syndromes
• Interventions: Drug: carboxymethylcellulose 0.5% +glycerin 0.9%; Drug: sodium hyaluronate 0.18%

• Registration Number: NCT00938704
• Lead Sponsor: Allergan

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Study First Submitted: 2009-07-10
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-14
• Status Verified: 2011-09
• Results First Submitted: 2011-09-22
• Results First Submitted QC: 2011-09-22
• Last Update Submitted: 2011-09-22
• Results First Posted: 2011-10-31
• Last Update Posted: 2011-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	carboxymethylcellulose 0.5% +glycerin 0.9%	carboxymethylcellulose 0.5%, glycerin 0.9%
2	sodium hyaluronate 0.18%	sodium hyaluronate 0.18%

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Tear Breakup Time (TBUT) at Week 2	Baseline, Week 2	Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement.
Change From Baseline in Corneal Staining at Week 2	Baseline, Week 2	Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Change From Baseline in Conjunctival Staining (Temporal) at Week 2	Baseline, Week 2	Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.
Change From Baseline in Conjunctival Staining (Nasal) at Week 2	Baseline, Week 2	Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement.