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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: December 6, 2016

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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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 Measures

  • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Allergan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kristopher Hansen, Study Director, Allergan

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