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A Study Evaluating the 24-Hour Intraocular Pressure Lowering Effect of Bimatoprost SR in Patients With Open-Angle 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04285580
Recruitment Status : Recruiting
First Posted : February 26, 2020
Last Update Posted : August 7, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the 24-hour intraocular pressure lowering effect and safety after a single administration of Bimatoprost SR in patients with Open-Angle Glaucoma or Ocular Hypertension

Condition or disease Intervention/treatment Phase
Open-Angle Glaucoma Ocular Hypertension Drug: Bimatoprost SR Drug: LUMIGAN Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 35 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Evaluation of the 24-Hour Intraocular Pressure(IOP)-Lowering Effect of Bimatoprost Sustained-Release(SR) in Participants With Open-Angle Glaucoma(OAG) or Ocular Hypertension(OHT)
Actual Study Start Date : June 11, 2020
Estimated Primary Completion Date : March 12, 2021
Estimated Study Completion Date : December 11, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: Bimatoprost SR 10 μg
Participants will receive Bimatoprost SR 10 μg implant in the study eye on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
Drug: Bimatoprost SR
Consists of 1 Bimatoprost SR administration in the study eye.

LUMIGAN 0.01%
Participants will receive topical LUMIGAN 0.01% in the study eye once daily starting evening Dose on Day 1 and standard of care treatment in the fellow eye for the duration of the study.
Drug: LUMIGAN
Treatment with LUMIGAN 0.01% begins on Day 1. The drop will be instilled once daily in the evening to the study eye throughout the duration of the study.




Primary Outcome Measures :
  1. Change from Baseline in Time-Matched Intraocular Pressure (IOP) for Bimatoprost SR treated eyes [ Time Frame: 8 weeks ]
    IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.

  2. Number of patients experiencing one or more treatment emergent adverse events (TEAEs) [ Time Frame: Up to 12 months ]
    The number of patients who experienced one or more TEAEs


Secondary Outcome Measures :
  1. Change from Baseline in range of IOP for Bimatoprost SR-treated eyes [ Time Frame: 8 Weeks ]
    IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.



Information from the National Library of Medicine

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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:
  • Diagnosis of either OAG or OHT study eye, requiring IOP-lowering treatment
  • Participant is currently a nonsmoker and has not smoked any nicotine-containing products within the previous 6 months
  • Exclusion Criteria:
  • Current or anticipated enrollment in another investigational drug or device study
  • Females who are pregnant, nursing, or planning a pregnancy 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): NCT04285580


Contacts
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Contact: Clinical Trial Registry Team 877-277-8566 IR-CTRegistration@allergan.com

Locations
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United States, Alabama
Eye Center South Not yet recruiting
Dothan, Alabama, United States, 36301
United States, California
Eye Research Foundation Recruiting
Newport Beach, California, United States, 92663
United States, Pennsylvania
Scott & Christie and Associates Recruiting
Cranberry Township, Pennsylvania, United States, 16066
Contact: Study Coordinator    724-772-5420      
United States, Texas
Keystone Research LTD Recruiting
Austin, Texas, United States, 78731
Contact: Study Coordinator    512-451-4400      
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Marina Bejanian Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT04285580    
Other Study ID Numbers: 1698-304-007
First Posted: February 26, 2020    Key Record Dates
Last Update Posted: August 7, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
Supporting Materials: Study Protocol
Clinical Study Report (CSR)
Time Frame: After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
Access Criteria: To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
URL: http://www.allerganclinicaltrials.com/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents