Efficacy and Safety Study for Ecabet Ophthalmic Solution for Treating Dry Eye Syndrome

• Sponsor: Bausch & Lomb Incorporated (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00370747
• Collaborator: (none)
• Enrollment: 162
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 18.1

Study Details

Study Description

Brief Summary

The purpose of this study is to determine whether ecabet ophthalmic solution is an effective treatment for dry eye syndrome

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndromes	Drug: Ecabet; Drug: Ecabet; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome
• Study Start Date: Sep 1, 2006
• Actual Primary Completion Date: Jun 1, 2007
• Actual Study Completion Date: Jun 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ecabet Ophthalmic solution in the Study eye four times daily for 90 days.	Drug: Ecabet; ophthalmic solution 2.83%; Drug: Ecabet; ophthalmic solution 3.70%
Placebo Comparator: Placebo Ophthalmic solution in the Study eye four times daily for 90 days.	Drug: Placebo

Outcome Measures

Primary Outcome Measures

1. Ocular signs and Symptoms [90 days]

   ocular signs, including corneal and conjunctival staining, tear film breakup time and blink rate, and ocular symptoms, including burning or stinging, itchiness or scratchiness, grittiness or sandiness, foreign body sensation, haziness or blurriness, photophobia, photopsia, and eye discomfort

Secondary Outcome Measures

1. Ocular Surface Disease Index (OSDI) [90 days]

   Questionaire

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Male/female at least 18 years of age

• Agree to avoid disallowed medications

• Have a diagnosis of dry eye

Exclusion Criteria:

• Have chronic systemic inflammation

• Have active seasonal ocular allergies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Irvine	California	United States	92618

Sponsors and Collaborators

• Bausch & Lomb Incorporated

Investigators

• Study Director: Ralph Bianca, PhD, ISTA Pharmaceuticals, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bausch & Lomb Incorporated
• ClinicalTrials.gov Identifier: NCT00370747
• Other Study ID Numbers: ISTA-ECBT-CS02
• First Posted: Sep 1, 2006
• Last Update Posted: Mar 15, 2013
• Last Verified: Mar 1, 2013

• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Syndrome; Ecabet

Study Results

No Results Posted as of Mar 15, 2013