Safety and Efficacy of a New Ophthalmic Formulation of Bimatoprost in Patients With Open Angle Glaucoma and Ocular Hypertension
This study is currently recruiting participants.
Verified April 2013 by Allergan
Sponsor:
Allergan
Information provided by (Responsible Party):
Allergan
ClinicalTrials.gov Identifier:
NCT01157364
First received: July 2, 2010
Last updated: April 3, 2013
Last verified: April 2013
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
- Stage 2: Change from Baseline in IOP [ Time Frame: Baseline, 24 Months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Stage 2: IOP [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- Time to Escape Medication/Procedure [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 160 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | March 2016 |
| Estimated Primary Completion Date: | March 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. 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.
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. 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.
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. 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.
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. 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.
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. 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.
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. 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.
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01157364
Contacts
| Contact: Allergan Inc. | clinicaltrials@allergan.com |
Locations
| United States, New York | |
| Recruiting | |
| Rochester, New York, United States | |
| Australia, New South Wales | |
| Terminated | |
| Sydney, New South Wales, Australia | |
| Australia | |
| Recruiting | |
| Fitzroy, Australia | |
| Belgium | |
| Recruiting | |
| Oogheelkunde, Belgium | |
| Canada | |
| Recruiting | |
| Vaughan, Canada | |
| Germany | |
| Recruiting | |
| Karlsruhe, Germany | |
| Israel | |
| Recruiting | |
| Tel Aviv, Israel | |
| Spain | |
| Recruiting | |
| Valencia, Spain | |
Sponsors and Collaborators
Allergan
Investigators
| Study Director: | Medical Director | Allergan |
More Information
Additional Information:
No publications provided
| Responsible Party: | Allergan |
| ClinicalTrials.gov Identifier: | NCT01157364 History of Changes |
| Other Study ID Numbers: | 192024-041D, 2011-005091-42 |
| Study First Received: | July 2, 2010 |
| Last Updated: | April 3, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Glaucoma Glaucoma, Open-Angle Hypertension Ocular Hypertension Eye Diseases Vascular Diseases Cardiovascular Diseases Timolol Latanoprost Bimatoprost Cloprostenol Adrenergic beta-Antagonists Adrenergic Antagonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Anti-Arrhythmia Agents Cardiovascular Agents Therapeutic Uses Antihypertensive Agents Luteolytic Agents Contraceptive Agents, Female Contraceptive Agents Reproductive Control Agents |
ClinicalTrials.gov processed this record on May 23, 2013