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24-hour Intraocular Pressure (IOP) Control With the Bimatoprost/Timolol Fixed Combination

NCT00486486 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2014-05-12

No results posted yet for this study

Summary

The objective of this crossover, randomized, placebo controlled, double-masked study is to compare the short-term (12 weeks) mean 24-hour IOP control and safety of the new fixed combination (bimatoprost/timolol, BTFC) given PM with placebo once in the morning, versus BTFC given AM with placebo once in the evening versus bimatoprost given in the evening in patients with exfoliative glaucoma (XFG).

Conditions

Interventions

DRUG

Drug: bimatoprost/timolol fixed combination AM

3-month chronic dosing in the morning

DRUG

Bimatoprost/timolol fixed combination dosed PM

Evening dosing of bimatoprost/timolol fixed combination for a period of 3 months

Sponsors & Collaborators

  • Aristotle University Of Thessaloniki

    lead OTHER

Principal Investigators

  • Anastasios Konstas, MD, PhD · Head of the Glaucoma Unit

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
39 Years
Max Age
81 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2008-05-31
Completion
2008-07-31

Countries

  • Greece

Study Locations

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Entities

Diseases

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 NCT00486486 on ClinicalTrials.gov