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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Allergan
Sponsor:
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01298700
First received: February 16, 2011
Last updated: February 5, 2014
Last verified: February 2014
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Percentage of Patients Reporting One or More Treatment-Related Ocular Surface Adverse Events excluding "Conjunctival Hyperemia" [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 784
Study Start Date: April 2011
Estimated Study Completion Date: December 2016
Estimated 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01298700

Contacts
Contact: Allergan Inc. clinicaltrials@allergan.com

Locations
Belgium
Recruiting
Leuven, Belgium
Czech Republic
Recruiting
Brno, Czech Republic
France
Recruiting
Lyon, France
Germany
Recruiting
Mainz, Rhineland-Palatinate, Germany
Hungary
Recruiting
Szeged, Hungary
Israel
Recruiting
Petach Tikva, Israel
Italy
Recruiting
Milano, Italy
Poland
Withdrawn
Gdańsk, Poland
Recruiting
Szczecin, Poland
Spain
Recruiting
Torrevieja, Alicante, Spain
United Kingdom
Recruiting
Norwich, United Kingdom
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Additional Information:
No publications provided

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01298700     History of Changes
Other Study ID Numbers: 192024-054
Study First Received: February 16, 2011
Last Updated: February 5, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Glaucoma
Hypertension
Ocular Hypertension
Eye Diseases
Vascular Diseases
Cardiovascular Diseases
Bimatoprost
Cloprostenol
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Luteolytic Agents
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 26, 2014