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

NCT01163643 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 356

Last updated 2020-09-25

Study results available
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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

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.

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Tuyen Ong, MD · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2011-06-30
Completion
2011-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01163643 on ClinicalTrials.gov