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Long-Term Safety of Bimatoprost Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension

NCT01298700 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2018-09-17

Study results available
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Summary

This study will evaluate the long-term safety of bimatoprost 0.01% ophthalmic solution compared with bimatoprost 0.03% ophthalmic solution in patients with glaucoma or ocular hypertension.

Conditions

Interventions

DRUG

bimatoprost 0.01% ophthalmic solution

One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

DRUG

bimatoprost 0.03% ophthalmic solution

One drop of bimatoprost 0.03% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Kristopher Hansen · Allergan

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2016-12-06
Completion
2016-12-06

Countries

  • Belgium
  • Czechia
  • France
  • Germany
  • Hungary
  • Israel
  • Italy
  • Poland
  • Spain
  • United Kingdom

Study Locations

More Related Trials

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 NCT01298700 on ClinicalTrials.gov