NCT01163643

Study to Assess the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

A Randomized, Double-Masked, Parallel-Group, Vehicle Controlled, Multicenter, Exploratory Study Assessing the Safety and Efficacy of BOL-303242-X Ophthalmic Suspension in Dry Eye Syndrome

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 356 (actual)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Dry Eye Syndrome

Interventions

Type	Name	Description
DRUG	0.3% BOL-303242-X ophthalmic suspension	0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.
DRUG	2% BOL-303242-X ophthalmic suspension	2% BOL-303242-X ophthalmic suspension BID for 12 weeks.
DRUG	Placebo Comparator: Vehicle	Placebo Comparator: Vehicle BID for 12 weeks.
DRUG	1% BOL-303242-X ophthalmic suspension	1% BOL-303242-X ophthalmic suspension BID for 12 weeks.
DRUG	2% BOL-303242-X ophthalmic suspension AM	2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.
DRUG	2% BOL-303242-X ophthalmic suspension PM	Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.

Timeline

• Start date: 2010-07-01
• Primary completion: 2011-06-01
• Completion: 2011-07-01
• First posted: 2010-07-16
• Last updated: 2020-09-25
• Results posted: 2020-09-03

Locations

1 site across 1 country: United States