Conditions: Dry Eye Syndromes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 315
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 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. arm 2: 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. arm 3: 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. arm 4: 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.

Interventions: intervention 1: Carboxymethylcellulose Based Eye Drop Formulation A intervention 2: Carboxymethylcellulose Based Eye Drop Formulation B intervention 3: Carboxymethylcellulose Based Preservative-Free Lubricant Eye Drops intervention 4: Carboxymethylcellulose Based Lubricant Eye Drops
Intervention descriptions: intervention 1: 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. intervention 2: 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. intervention 3: 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. intervention 4: 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.

Protocol document: