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Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT03850782
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : August 26, 2021
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 : 490 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 : January 29, 2025

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 48 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 48 visit.

Fellow Eye: Standard of care or Bimatoprost SR





Primary Outcome Measures :
  1. Retreatment or rescue administered for IOP [ Time Frame: Up to 36 months ]
    Treatment modality determined by investigator.

  2. Number of patients experiencing a treatment emergent adverse event [ Time Frame: Baseline up to 48 months ]
    The number of patients who experienced one or more TEAE during the 48 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: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
Allergan
Investigators
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Study Director: ALLERGAN INC. Allergan
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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: August 26, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: For details on when studies are available for sharing, please refer to the link below
Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
URL: https://vivli.org/ourmember/abbvie/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: 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