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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 : October 8, 2021
Sponsor:
Information provided by (Responsible Party):
Allergan

Tracking Information
First Submitted Date  ICMJE February 11, 2019
First Posted Date  ICMJE February 22, 2019
Last Update Posted Date October 8, 2021
Actual Study Start Date  ICMJE February 28, 2019
Estimated Primary Completion Date January 30, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 1, 2021)
  • Retreatment or rescue administered for IOP [ Time Frame: Up to 48 months ]
    Treatment modality determined by investigator.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • Retreatment or rescue administered for IOP [ Time Frame: Up to 30 months ]
    Treatment modality determined by investigator
  • 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
Official Title  ICMJE A Phase 3b Study to Evaluate the Duration of Effect of Bimatoprost SR in Participants With Open-Angle Glaucoma or Ocular Hypertension
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Open-Angle Glaucoma
  • Ocular Hypertension
Intervention  ICMJE Drug: Bimatoprost (SR)

Study Eye: Cycles 1 - 3 administrations through the PRN treatment period.

Fellow Eye: Standard of care or Bimatoprost SR.

Study Arms  ICMJE
  • 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.

    Intervention: Drug: 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.

    Intervention: Drug: Bimatoprost (SR)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 5, 2021)
490
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2019)
300
Estimated Study Completion Date  ICMJE January 30, 2025
Estimated Primary Completion Date January 30, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com
Listed Location Countries  ICMJE Argentina,   Australia,   Bulgaria,   Czechia,   Denmark,   Germany,   Hungary,   Ireland,   Italy,   New Zealand,   Poland,   Russian Federation,   South Africa,   Sweden,   United Kingdom,   United States
Removed Location Countries France
 
Administrative Information
NCT Number  ICMJE NCT03850782
Other Study ID Numbers  ICMJE 1698-301-007
2018-002574-52 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ALLERGAN INC. Allergan
PRS Account Allergan
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP