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Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01157364
First Posted: July 7, 2010
Last Update Posted: October 24, 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 safety and efficacy of new ophthalmic formulations of bimatoprost in patients with open angle glaucoma and ocular hypertension. At least 3 formulations will be evaluated based on internal data review of each cohort. The study will be conducted in 2 stages. Stage 1 is open-label and Stage 2 is masked.

Condition Intervention Phase
Open-Angle Glaucoma Ocular Hypertension Drug: bimatoprost ophthalmic formulation A Drug: bimatoprost ophthalmic formulation B Drug: bimatoprost ophthalmic formulation C Drug: bimatoprost ophthalmic formulation D Drug: bimatoprost ophthalmic formulation E Drug: bimatoprost ophthalmic formulation F Drug: Sham Drug: timolol 0.5% Drug: bimatoprost ophthalmic solution 0.03% Drug: latanoprost 0.005% Drug: timolol vehicle (placebo) Phase 1 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Allergan:

Primary Outcome Measures:
  • Stage 1: Change from Baseline in Intraocular Pressure (IOP) [ Time Frame: Baseline, 24 Months ]
  • Stage 2: Change from Baseline in IOP [ Time Frame: Baseline, 24 Months ]

Secondary Outcome Measures:
  • Stage 2: IOP [ Time Frame: 24 Months ]
  • Time to Escape Treatment [ Time Frame: 24 Months ]
  • Time to Second Injection [ Time Frame: 24 Months ]

Enrollment: 109
Study Start Date: August 2010
Study Completion Date: July 2016
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Stage 1: bimatoprost formulation A, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic formulation A administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Drug: bimatoprost ophthalmic formulation A
Single dose of bimatoprost ophthalmic formulation A administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Drug: bimatoprost ophthalmic solution 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Other Name: LUMIGAN®
Stage 1: bimatoprost formulation B, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic formulation B administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Drug: bimatoprost ophthalmic formulation B
Single dose of bimatoprost ophthalmic formulation B administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Drug: bimatoprost ophthalmic solution 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Other Name: LUMIGAN®
Stage 1: bimatoprost formulation C, bimatoprost 0.03%
Single dose of bimatoprost ophthalmic formulation C administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Drug: bimatoprost ophthalmic formulation C
Single dose of bimatoprost ophthalmic formulation C administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Drug: bimatoprost ophthalmic solution 0.03%
One drop bimatoprost ophthalmic solution 0.03% (LUMIGAN®) administered in the non-study eye once daily every evening for up to 24 months.
Other Name: LUMIGAN®
Stage 2: bimatoprost formulation D, latanoprost 0.005%
Single dose of bimatoprost ophthalmic formulation D administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop latanoprost 0.005% (Xalatan®) administered once daily every evening in the non-study eye for up to 24 months. One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle (for masking purposes) administered in the non-study eye once daily in the morning for up to 24 months.
Drug: bimatoprost ophthalmic formulation D
Single dose of bimatoprost ophthalmic formulation D administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Drug: latanoprost 0.005%
One drop latanoprost 0.005% (Xalatan®) administered in the non-study eye once daily in the evening or in the non-study eye and study eye once daily in the evening for up to 24 months.
Other Name: Xalatan®
Drug: timolol vehicle (placebo)
One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle administered in the non-study eye once daily in the morning, or 1 drop of timolol vehicle administered once in the morning in both eyes for up to 24 months. Timolol vehicle is administered for masking purposes.
Stage 2: bimatoprost formulation E, latanoprost 0.005%
Single dose of bimatoprost ophthalmic formulation E administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop latanoprost 0.005% (Xalatan®) administered once daily every evening in the non-study eye for up to 24 months. One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle (for masking purposes) administered in the non-study eye once daily in the morning for up to 24 months.
Drug: bimatoprost ophthalmic formulation E
Single dose of bimatoprost ophthalmic formulation E administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Drug: latanoprost 0.005%
One drop latanoprost 0.005% (Xalatan®) administered in the non-study eye once daily in the evening or in the non-study eye and study eye once daily in the evening for up to 24 months.
Other Name: Xalatan®
Drug: timolol vehicle (placebo)
One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle administered in the non-study eye once daily in the morning, or 1 drop of timolol vehicle administered once in the morning in both eyes for up to 24 months. Timolol vehicle is administered for masking purposes.
Stage 2: bimatoprost formulation F, latanoprost 0.005%
Single dose of bimatoprost ophthalmic formulation F administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable). One drop latanoprost 0.005% (Xalatan®) administered once daily every evening in the non-study eye for up to 24 months. One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle (for masking purposes) administered in the non-study eye once daily in the morning for up to 24 months.
Drug: bimatoprost ophthalmic formulation F
Single dose of bimatoprost ophthalmic formulation F administered in the study eye on Day 1, and once between 90 days and 12 months after the first dose (if applicable).
Drug: latanoprost 0.005%
One drop latanoprost 0.005% (Xalatan®) administered in the non-study eye once daily in the evening or in the non-study eye and study eye once daily in the evening for up to 24 months.
Other Name: Xalatan®
Drug: timolol vehicle (placebo)
One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle administered in the non-study eye once daily in the morning, or 1 drop of timolol vehicle administered once in the morning in both eyes for up to 24 months. Timolol vehicle is administered for masking purposes.
Stage 2: Sham, latanoprost 0.005%
Sham administration in the study eye on Day 1. One drop of latanoprost 0.005% (Xalatan®) administered once daily in the evening in the study eye and non-study eye for up to 24 months. One drop of timolol vehicle (for masking purposes) administered once in the morning in both eyes for up to 24 months.
Drug: Sham
Sham administration in the study eye on Day 1.
Drug: latanoprost 0.005%
One drop latanoprost 0.005% (Xalatan®) administered in the non-study eye once daily in the evening or in the non-study eye and study eye once daily in the evening for up to 24 months.
Other Name: Xalatan®
Drug: timolol vehicle (placebo)
One drop of timolol vehicle administered in the study eye in the morning and evening, and 1 drop of timolol vehicle administered in the non-study eye once daily in the morning, or 1 drop of timolol vehicle administered once in the morning in both eyes for up to 24 months. Timolol vehicle is administered for masking purposes.
Stage 2: Sham, timolol 0.5%
Sham administration in the study eye on Day 1. Two drops of timolol 0.5% (Timoptic®) administered in the study and non-study eyes once in the morning and once in the evening daily for up to 24 months.
Drug: Sham
Sham administration in the study eye on Day 1.
Drug: timolol 0.5%
Two drops timolol 0.5% (Timoptic®) administered in the study and non-study eyes once in the morning and once in the evening daily for up to 24 months.
Other Name: Timoptic®

  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:

  • Diagnosis of open angle glaucoma or ocular hypertension

Exclusion Criteria:

  • Uncontrolled medical conditions
  • 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): NCT01157364


  Show 57 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Medical Director Allergan
  More Information

Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT01157364     History of Changes
Other Study ID Numbers: 192024-041D
2011-005091-42 ( EudraCT Number )
First Submitted: July 2, 2010
First Posted: July 7, 2010
Last Update Posted: October 24, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Pharmaceutical Solutions
Ophthalmic Solutions
Timolol
Latanoprost
Bimatoprost
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Arrhythmia Agents
Antihypertensive Agents