Conditions: Dry Eye Syndromes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 242
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Carboxymethylcellulose Based Eye Drop intervention 2: Carboxymethylcellulose Sodium 0.5%
Intervention descriptions: intervention 1: Carboxymethylcellulose based eye drop (OM3 Tear) administered as 1-2 drops in each eye, as needed, at least 2 times daily for 90 days. intervention 2: 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.

Protocol document: