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Trial record 2 of 12 for:    Allergan | Asheville, North Carolina, U.S.

Long-term Safety and Efficacy Extension Trial of Bimatoprost SR

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: NCT03891446
Recruitment Status : Recruiting
First Posted : March 27, 2019
Last Update Posted : February 24, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

Brief Summary:
This study will evaluate the long-term safety and efficacy of Bimatoprost SR in patients with open-angle glaucoma or ocular hypertension who completed 1 of the 4 Phase 3 Bimatoprost SR studies (192024-091, -092, -093, or -095) and received Bimatoprost SR.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Extension Trial to Evaluate the Long-term Safety and Efficacy of Bimatoprost SR in Patients With Open Angle Glaucoma or Ocular Hypertension
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : January 21, 2024
Estimated Study Completion Date : January 21, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: Bimatoprost SR 10mcg; Lead-in study 192024-093

Study eye: Eye that received Bimatoprost SR in the lead-in study. Patients from Stage 2 of lead-in studies 093/095 are eligible to receive up to 2 additional Bimatoprost SR administrations of the same dose in the study eye through completion of Month 12 visit

Fellow eye: Eye that did not receive Bimatoprost SR in the lead-in study. Fellow eye will receive only standard of care for intraocular pressure (IOP) lowering, based on the investigator's judgment.

Drug: Bimatoprost SR

Patients from Stage 2 of lead-in studies 093/095 are eligible to receive up to 2 additional Bimatoprost SR administrations of the same dose in the study eye through completion of Month 12 visit.

Patients from lead-in studies 091/092 will not receive additional Bimatoprost SR administrations in the study eye.

Fellow eye of all patients will receive only standard of care based on the investigator's judgment


Experimental: Bimatoprost SR 15mcg; Lead-in studies 192024-093/-095

Study eye: Eye that received Bimatoprost SR in the lead-in study. Patients from Stage 2 of lead-in studies 093/095 are eligible to receive up to 2 additional Bimatoprost SR administrations of the same dose in the study eye through completion of Month 12 visit

Fellow eye: Eye that did not receive Bimatoprost SR in the lead-in study. Fellow eye will receive only standard of care for intraocular pressure (IOP) lowering, based on the investigator's judgment.

Drug: Bimatoprost SR

Patients from Stage 2 of lead-in studies 093/095 are eligible to receive up to 2 additional Bimatoprost SR administrations of the same dose in the study eye through completion of Month 12 visit.

Patients from lead-in studies 091/092 will not receive additional Bimatoprost SR administrations in the study eye.

Fellow eye of all patients will receive only standard of care based on the investigator's judgment


Experimental: Bimatoprost SR 10mcg; Lead-in studies 192024-091/-092

Study eye: Eye that received Bimatoprost SR in the lead-in study. Patients from lead-in studies 091/092 will not receive additional Bimatoprost SR administrations in the study eye

Fellow eye: Eye that did not receive Bimatoprost SR in the lead-in study. Fellow eye will receive only standard of care for intraocular pressure (IOP) lowering, based on the investigator's judgment.

Drug: Bimatoprost SR

Patients from Stage 2 of lead-in studies 093/095 are eligible to receive up to 2 additional Bimatoprost SR administrations of the same dose in the study eye through completion of Month 12 visit.

Patients from lead-in studies 091/092 will not receive additional Bimatoprost SR administrations in the study eye.

Fellow eye of all patients will receive only standard of care based on the investigator's judgment


Experimental: Bimatoprost SR 15mcg; Lead-in studies 192024-091/-092

Study eye: Eye that received Bimatoprost SR in the lead-in study. Patients from lead-in studies 091/092 will not receive additional Bimatoprost SR administrations in the study eye

Fellow eye: Eye that did not receive Bimatoprost SR in the lead-in study. Fellow eye will receive only standard of care for intraocular pressure (IOP) lowering, based on the investigator's judgment.

Drug: Bimatoprost SR

Patients from Stage 2 of lead-in studies 093/095 are eligible to receive up to 2 additional Bimatoprost SR administrations of the same dose in the study eye through completion of Month 12 visit.

Patients from lead-in studies 091/092 will not receive additional Bimatoprost SR administrations in the study eye.

Fellow eye of all patients will receive only standard of care based on the investigator's judgment





Primary Outcome Measures :
  1. Duration of effect of Bimatoprost SR [ Time Frame: Approximately 24 months ]
    Retreatment or rescue administered for IOP lowering, determined by the investigator

  2. Number of patients experiencing a treatment emergent adverse event. [ Time Frame: Approximately 24 months ]
    The number of patients who experienced one or more TEAE during the 24 month treatment period.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

- Patients who completed 1 of the 4 Bimatoprost SR Phase 3 studies (192024-091, -092, -093, or -095) and received Bimatoprost SR

Exclusion Criteria:

  • Female patients who are pregnant, nursing, or planning a pregnancy, or who are of childbearing potential and not using a reliable means of contraception during the study
  • Concurrent or anticipated enrollment in another investigational drug or device study during the present study
  • Any condition which would preclude the patient's ability to comply with study requirements, including completion of the study
  • Patients who were randomized to receive timolol eye drops in the study eye (control group) during the Phase 3 Bimatoprost Studies 192024-091 and -092

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): NCT03891446


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

Locations
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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: NCT03891446    
Other Study ID Numbers: 1698-302-007
2018-003597-26 ( EudraCT Number )
First Posted: March 27, 2019    Key Record Dates
Last Update Posted: February 24, 2020
Last Verified: February 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