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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01298700
First Posted: February 18, 2011
Last Update Posted: December 12, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Allergan
  Purpose
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.

Condition Intervention Phase
Glaucoma Ocular Hypertension Drug: bimatoprost 0.01% ophthalmic solution Drug: bimatoprost 0.03% ophthalmic solution Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 2-year, Multicenter, Double-masked, Randomized, Parallel Study of the Safety of LUMIGAN® 0.1 mg/mL Compared With LUMIGAN® 0.3 mg/mL in Patients With Glaucoma or Ocular Hypertension

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events [ Time Frame: Month 24 ]

Secondary Outcome Measures:
  • Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events excluding "Conjunctival Hyperemia" [ Time Frame: Month 24 ]

Enrollment: 807
Study Start Date: April 2011
Study Completion Date: December 2016
Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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 0.01% ophthalmic solution
One drop of bimatoprost 0.01% ophthalmic solution instilled to each eye, once daily in the evening for 2 years.
Other Names:
  • LUMIGAN® 0.01%
  • LUMIGAN 0.1 mg/ml
Active Comparator: 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.
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.
Other Names:
  • LUMIGAN® 0.03%
  • LUMIGAN 0.3 mg/ml

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Ocular hypertension or glaucoma in each eye
  • Requires intraocular pressure (IOP)-lowering therapy in both eyes
  • Best corrected visual acuity of 20/100 or better in each eye

Exclusion Criteria:

  • Ocular seasonal allergies within 2 years
  • Required chronic use of ocular medications during the study (intermittent use of artificial tears is allowed)
  • Ocular surgery or laser within 3 months
  • Anticipated wearing of contact lenses during the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01298700


  Show 49 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Kristopher Hansen Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01298700     History of Changes
Other Study ID Numbers: 192024-054
First Submitted: February 16, 2011
First Posted: February 18, 2011
Last Update Posted: December 12, 2016
Last Verified: December 2016

Additional relevant MeSH terms:
Hypertension
Glaucoma
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Bimatoprost
Antihypertensive Agents