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

Dry Eye Syndromes Clinical Trial

Official title:

Efficacy and Safety of Ecabet Ophthalmic Solution for the Treatment of Dry Eye Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00370747
• Other study ID #: ISTA-ECBT-CS02
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2006
• Last updated: March 13, 2013
• Start date: September 2006
• Est. completion date: June 2007

Study information

• Verified date: March 2013
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: June 2007
• Est. primary completion date: June 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dry Eye Syndromes
• Keratoconjunctivitis Sicca
• Syndrome

Intervention

Drug:
• Ecabet
ophthalmic solution 2.83%
• Ecabet
ophthalmic solution 3.70%
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular signs and Symptoms	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	90 days	No
Secondary	Ocular Surface Disease Index (OSDI)	Questionaire	90 days	No