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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 : May 7, 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 May 7, 2021
Actual Study Start Date  ICMJE February 28, 2019
Estimated Primary Completion Date July 17, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2021)
  • Retreatment or rescue administered for IOP [ Time Frame: Up to 36 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
  • Glaucoma, Open-Angle
  • Ocular Hypertension
Intervention  ICMJE Drug: Bimatoprost (SR)

Study Eye: Cycles 1 - 3 administrations through the Month 48 visit.

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 July 17, 2023
Estimated Primary Completion Date July 17, 2023   (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: Clinical Trials Registry Team 1-877-277-8566 IR-CTRegistration@allergan.com
Listed Location Countries  ICMJE Bulgaria,   Czechia,   Denmark,   France,   Germany,   Hungary,   Ireland,   Italy,   Poland,   South Africa,   Sweden,   United Kingdom,   United States
Removed Location Countries  
 
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
IPD Sharing Statement  ICMJE
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/
Responsible Party Allergan
Study Sponsor  ICMJE Allergan
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Saumya Nagar Allergan
PRS Account Allergan
Verification Date May 2021

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