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

Efficacy and Safety of Ecabet Ophthalmic Solution (2.83% and 3.70%) for Treatment of Dry Eye Syndrome

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00198536

Enrollment

159

Registered

2005-09-20

Start date

2005-04-30

Completion date

2005-12-31

Last updated

2013-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Syndromes

Brief summary

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

Interventions

DRUGEcabet 2.83%

DRUGEcabet 3.70%

DRUGVehicle

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Agree to avoid systemic & topical ophthalmic meds & disallowed meds * Have a best corrected visual acuity (BCVA) of 20/40 with pinhole or better in each eye * Diagnosis of moderate dry eye syndrome

Exclusion criteria

* Uncontrolled ocular or systemic disease that could interfere with study * Diagnosis of Sjogren's syndrome, lacrimal obstruction, reflex, lid-related or contact lens-related dry eye syndrome(DES); significant anterior blepharitis or meibomianitis * Contraindications or hypersensitivity to use of study meds or components * Wear contact lenses * Secondary dry eye to surgery * Eye surgery (including laser) within 6 months * Use of systemic or topical ophthalmic meds within 14 days * Punctal plugs in one or both eyes in place for \<45 days * Permanent occlusion of the lacrimal puncta

Design outcomes

Primary

Measure	Time frame	Description
Ocular discomfort	Day 91	Group mean change in ocular discomfort score from pre-Cataract extraction (CAE) to post-CAE
Tear Film Break-up Time (TFBUT)	Day 91	Group mean change in time to tear break-up from pre-CAE to post-CAE.
Blink Rate	Day 91	Group mean change in blinks/min from pre-CAE to post-CAE.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026