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Evaluation of the Duration of Effect of Bimatoprost SR in Participants 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: NCT03850782
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : June 5, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study evaluates the duration of intraocular pressure (IOP)-lowering effect and safety of as needed administrations of Bimatoprost sustained release (SR) in participants with open-angle glaucoma (OAG) or ocular hypertension (OHT) who are not adequately managed with topical IOP-lowering medication for reasons other than medication efficacy.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Actual Study Start Date : February 28, 2019
Estimated Primary Completion Date : July 17, 2023
Estimated Study Completion Date : July 17, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: Bimatoprost SR - Dose A

Study Eye: Participants will receive 1 - 3 Cycles of Bimatoprost SR administrations of Dose A

Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.

Drug: Bimatoprost (SR)

Study Eye: Cycles 1 - 3 administrations through the Month 18 visit.

Fellow Eye: Standard of care or Bimatoprost SR


Experimental: Bimatoprost SR - Dose B

Study Eye: Participants received 1-3 Cycles of Bimatoprost SR administrations of Dose B

Fellow Eye: The eye that does not receive Bimatoprost SR treatment will receive standard of care or up to one administration of Bimatoprost SR.

Drug: Bimatoprost (SR)

Study Eye: Cycles 1 - 3 administrations through the Month 18 visit.

Fellow Eye: Standard of care or Bimatoprost SR





Primary Outcome Measures :
  1. Retreatment or rescue administered for IOP [ Time Frame: Up to 30 months ]
    Treatment modality determined by investigator

  2. Number of patients experiencing a treatment emergent adverse event. [ Time Frame: Baseline up to 30 months ]
    The number of patients who experienced one or more TEAE during the 30 month treatment period.



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 Diagnosis of either open angle glaucoma (OAG) (i.e., primary OAG, pseudoexfoliation glaucoma, pigmentary glaucoma) or ocular hypertension requiring intraocular pressure-lowering treatment

Exclusion Criteria:

  • Concurrent or anticipated enrollment in another investigational drug or device study or participation in such a study within 2 months prior to enrolling in this study
  • Previous administration with Bimatoprost SR in the study eye

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): NCT03850782


Contacts
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Contact: Clinical Trials Registry Team 1-877-277-8566 IR-CTRegistration@allergan.com

Locations
Show Show 98 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Saumya Nagar Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT03850782    
Other Study ID Numbers: 1698-301-007
2018-002574-52 ( EudraCT Number )
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: June 5, 2020
Last Verified: June 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
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 noncommercial 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