A Study to Compare the Safety and Efficacy of A New Eye Drop Formulation With OPTIVE™ in Subjects With Dry Eye Disease

Allergan

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: Carboxymethylcellulose Based Eye Drop Formulation A; Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT01664949

2012-002238-35 (EudraCT Number)

11002X-001

Details and patient eligibility

About

This study will evaluate the safety and efficacy of a carboxymethylcellulose based eye drop formulation compared with carboxymethylcellulose based preservative-free lubricant eye drops (OPTIVE™) in subjects with dry eye disease.

Enrollment: 460 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Have used artificial tears for dry eye

Exclusion criteria

• Start date of over the counter, herbal, prescription or nutritional supplements that may affect dry eye or vision within 3 months prior to study start or an anticipated change in dosage during the study
• History of eye surgery or trauma in the 6 months prior to study start
• Current use or use within 2 weeks of study start, of topical eye medications.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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460 participants in 2 patient groups

Carboxymethylcellulose Based Eye Drop Formulation A

Experimental group

Description:

Carboxymethylcellulose Based Eye Drop Formulation A 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Treatment:

Drug: Carboxymethylcellulose Based Eye Drop Formulation A

OPTIVE™

Active Comparator group

Description:

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (OPTIVE™) 1-2 drops in each eye as needed at least 2 times daily for 90 days.

Treatment:

Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops