CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 356 enrolled
Drug / intervention
0.3% BOL-303242-X ophthalmic suspension +5 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01163643
NCT01163643Phase 2Completed
CompareCT.gov

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

Bausch & Lomb Incorporated·interventional·Posted Jul 16, 2010·Updated Sep 25, 2020

In Brief

A Phase 2 clinical trial evaluating 0.3% BOL-303242-X ophthalmic suspension, 2% BOL-303242-X ophthalmic suspension, and 4 other interventions for Dry Eye Syndrome. Completed, enrolled 356 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDry Eye Syndrome
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJul 16, 2010
Enrollment StartJul 1, 2010
Primary CompletionJun 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 16.0 years ago

Interventions

0.3% BOL-303242-X ophthalmic suspensiondrug

0.3% BOL-303242-X ophthalmic suspension BID for 12 weeks.

2% BOL-303242-X ophthalmic suspensiondrug

2% BOL-303242-X ophthalmic suspension BID for 12 weeks.

Placebo Comparator: Vehicledrug

Placebo Comparator: Vehicle BID for 12 weeks.

1% BOL-303242-X ophthalmic suspensiondrug

1% BOL-303242-X ophthalmic suspension BID for 12 weeks.

2% BOL-303242-X ophthalmic suspension AMdrug

2% BOL-303242-X ophthalmic suspension once daily (QD) AM and vehicle QD in PM for 12 weeks.

2% BOL-303242-X ophthalmic suspension PMdrug

Vehicle QD AM and 2% BOL-303242-X ophthalmic suspension QD in PM for 12 weeks.