Safety, Efficacy, and Acceptability Study of an Eye Drop Formulation in Subjects With Dry Eye Disease

Allergan

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01459588

10146X-001

Details and patient eligibility

About

This study will evaluate the safety, efficacy, and acceptability of an eye drop formulation in subjects with dry eye disease.

Enrollment: 315 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Dry eyes
• Current use of eye drops for dry eye at least twice daily, on average for at least 3 months

Exclusion criteria

• Cataract, laser-assisted in situ keratomileusis (LASIK), or photorefractive keratectomy (PRK) surgery in the last 12 months
• Need to wear contact lenses during the study, or has worn contact lenses in the last 6 months
• Active ocular allergy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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315 participants in 4 patient groups

Carboxymethylcellulose Based Eye Drop Formulation A

Experimental group

Description:

Carboxymethylcellulose Based Eye Drop Formulation A (Refresh Optive® Advanced Sensitive Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

Treatment:

Drug: Carboxymethylcellulose Based Eye Drop Formulation A

Carboxymethylcellulose Based Eye Drop Formulation B

Experimental group

Description:

Carboxymethylcellulose Based Eye Drop Formulation B (Refresh Optive® Advanced Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Treatment:

Drug: Carboxymethylcellulose Based Eye Drop Formulation B

Carboxymethylcellulose Preservative-Free Lubricant Eye Drops

Active Comparator group

Description:

Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops (Optive® Sensitive Preservative-Free Lubricant Eye Drops) 1-2 drops in each eye as needed at least 2 times daily for 30 days.

Treatment:

Drug: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops

Carboxymethylcellulose Based Lubricant Eye Drops

Active Comparator group

Description:

Carboxymethylcellulose Based Lubricant Eye Drops (Optive® Lubricant Eye Drops) 1-2 drops in each eye as needed, at least 2 times daily for 30 days.

Treatment:

Drug: Carboxymethylcellulose Based Lubricant Eye Drops