Conditions: Dry Eye Syndrome
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 356
Healthy volunteers: no

Brief summary:
The objective of this study is to identify the concentration and daily dosing frequency of BOL-303242-X ophthalmic suspension in treating dry eye syndrome over a 12 week dosing period.

Detailed description:

Arms:
arm 1: 0.3% BOL-303242-X ophthalmic suspension arm 2: 2% BOL-303242-X ophthalmic suspension arm 3: Vehicle twice daily (BID) arm 4: 1% BOL-303242-X ophthalmic suspension arm 5: 2% BOL-303242-X ophthalmic suspension in the morning (AM) and vehicle in the afternoon (PM) arm 6: Vehicle in the AM and 2% BOL-303242-X ophthalmic suspension in the PM.

Interventions: intervention 1: 0.3% BOL-303242-X ophthalmic suspension intervention 2: 2% BOL-303242-X ophthalmic suspension intervention 3: Placebo Comparator: Vehicle intervention 4: 1% BOL-303242-X ophthalmic suspension intervention 5: 2% BOL-303242-X ophthalmic suspension AM intervention 6: 2% BOL-303242-X ophthalmic suspension PM
Intervention descriptions: intervention 1: 0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks. intervention 2: 2% BOL-303242-X ophthalmic suspension BID for 12 weeks. intervention 3: Placebo Comparator: Vehicle BID for 12 weeks. intervention 4: 1% BOL-303242-X ophthalmic suspension BID for 12 weeks. intervention 5: 2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks. intervention 6: Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.

Protocol document: