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Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension

NCT01223378 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 413

Last updated 2018-07-24

Study results available
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Summary

The objective of this clinical investigation is to determine the most effective drug concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical development of an appropriate dose with regard to efficacy, and ocular and systemic safety.

Conditions

  • Intraocular Pressure

Interventions

DRUG

BOL-303259-X

ophthalmic solution, various concentrations, once daily (QD) 28 days

DRUG

Latanoprost

0.005% ophthalmic solution, QD 28 days

Sponsors & Collaborators

  • Bausch & Lomb Incorporated

    lead INDUSTRY

Principal Investigators

  • Rabia Ozden, MD · Bausch & Lomb Incorporated

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-13
Primary Completion
2011-12-20
Completion
2012-06-22
FDA Drug
Yes

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 NCT01223378 on ClinicalTrials.gov