A Multicenter, Double-masked, Randomized Study to Compare the Safety and Efficacy of the OM3 Tear Formulation With REFRESH OPTIVE® ADVANCED Unit Dose for 3 Months in Patients With Dry Eye Disease

Allergan13 sites in 2 countries242 target enrollmentJanuary 6, 2016

ConditionsDry Eye Syndromes

InterventionsCarboxymethylcellulose Based Eye Drop Carboxymethylcellulose Sodium 0.5%

DrugsCarboxymethylcellulose Based Eye Drop Carboxymethylcellulose Sodium 0.5%

Overview

Phase: Phase 3
Intervention: Carboxymethylcellulose Based Eye Drop
Conditions: Dry Eye Syndromes
Sponsor: Allergan
Enrollment: 242
Locations: 13
Primary Endpoint: Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study will evaluate the safety and efficacy of a new eye drop formulation in patients with dry eye disease.

Registry

clinicaltrials.gov

Start Date

January 6, 2016

End Date

September 9, 2016

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Allergan

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Used artificial tears for dry eye
•Visual acuity of at least 20/32 (while wearing glasses, if necessary).

Exclusion Criteria

•Use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study
•Herpes keratitis in the last 6 months
•Cataract surgery, laser-assisted in situ keratomileusis \[LASIK\], or photorefractive keratectomy, within the last 6 months

Arms & Interventions

OM3 Tear

Carboxymethylcellulose based eye drop \[Omega-3 (OM3) Tear\] administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Intervention: Carboxymethylcellulose Based Eye Drop

REFRESH OPTIVE® ADVANCED

Carboxymethylcellulose sodium 0.5% (REFRESH OPTIVE® ADVANCED) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days.

Intervention: Carboxymethylcellulose Sodium 0.5%

Outcomes

Primary Outcomes

Change From Baseline in the Ocular Surface Disease Index© (OSDI©) Score

Time Frame: Baseline, Day 90

The OSDI© consists of 12 questions the patient is asked measuring the presence of ocular symptoms. Each of the 12 questions was assessed using a 5-point scale where 0=none of the time and 4=all of the time. The score is converted to a 0 to 100-point score where 0 is no symptoms and 100 is most symptoms. A negative change from Baseline indicates improvement.