A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.

Allergan

Status and phase: Completed; Phase 3

Conditions: Dry Eye Syndromes

Treatments: Drug: Carboxymethylcellulose Based Eye Drop; Drug: Carboxymethylcellulose Sodium 0.5%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02553772

11182X-001

Details and patient eligibility

About

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

Enrollment: 242 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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242 participants in 2 patient groups

OM3 Tear

Experimental group

Description:

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.

Treatment:

Drug: Carboxymethylcellulose Based Eye Drop

REFRESH OPTIVE® ADVANCED

Active Comparator group

Description:

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.

Treatment:

Drug: Carboxymethylcellulose Sodium 0.5%