Conditions: Dry Eye Syndromes
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 79
Healthy volunteers: no

Brief summary:
A study to evaluate the tolerability and acceptability of an investigational eye drop formulation in patients with Dry Eye Disease.

Detailed description:

Arms:
arm 1: 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks. arm 2: 1 to 2 drops of Systane® Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks. arm 3: 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks followed 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks. arm 4: 1 to 2 drops of New Eye Drop Formulation (carboxymethylcellulose sodium based eye drops) in each eye as needed at least 2 times daily for 2 weeks followed by 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye as needed at least 2 times daily for 2 weeks.

Interventions: intervention 1: Carboxymethylcellulose Sodium Based Eye Drops intervention 2: Systane® Gel Drops intervention 3: Genteal® Lubricant Gel Drops
Intervention descriptions: intervention 1: 1 to 2 drops of Carboxymethylcellulose Sodium Based Eye Drops \[New Eye Drop Formula\] in each eye. intervention 2: 1 to 2 drops of Systane® Gel Drops in each eye. intervention 3: 1 to 2 drops of Genteal® Lubricant Gel Drops in each eye.

Protocol document: