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

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.
 
ClinicalTrials.gov Identifier: NCT01298700
Recruitment Status : Completed
First Posted : February 18, 2011
Results First Posted : September 17, 2018
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief 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.

Condition or disease Intervention/treatment Phase
Glaucoma Ocular Hypertension Drug: bimatoprost 0.01% ophthalmic solution Drug: bimatoprost 0.03% ophthalmic solution Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 806 participants
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
Actual Study Start Date : May 31, 2011
Actual Primary Completion Date : December 6, 2016
Actual Study Completion Date : December 6, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: 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




Primary Outcome Measures :
  1. Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events [ Time Frame: 24 Months ]
    An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator are reported.


Secondary Outcome Measures :
  1. Percentage of Participants Reporting One or More Treatment-Related Ocular Surface Adverse Events Excluding "Conjunctival Hyperemia" [ Time Frame: 24 Months ]
    An adverse event (AE) was defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and that did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The percentage of participants with ocular (eye) surface AEs deemed related to treatment by the investigator excluding AEs with the preferred term Conjunctival hyperemia are reported.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


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Sponsors and Collaborators
Allergan
Investigators
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Study Director: Kristopher Hansen Allergan

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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01298700     History of Changes
Other Study ID Numbers: 192024-054
2010-023917-68 ( EudraCT Number )
First Posted: February 18, 2011    Key Record Dates
Results First Posted: September 17, 2018
Last Update Posted: September 17, 2018
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Bimatoprost
Ophthalmic Solutions
Pharmaceutical Solutions
Antihypertensive Agents