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Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients 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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02507687
Recruitment Status : Active, not recruiting
First Posted : July 24, 2015
Last Update Posted : November 4, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study will evaluate the intraocular pressure-lowering effect and safety of Bimatoprost SR compared with selective laser trabeculoplasty in patients with open-angle glaucoma or ocular hypertension who are not adequately managed with topical IOP-lowering medication.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Ocular Hypertension Drug: Bimatoprost SR Drug: Sham Bimatoprost SR Procedure: Selective Laser Trabeculoplasty Procedure: Sham Selective Laser Trabeculoplasty Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 215 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension
Actual Study Start Date : August 27, 2015
Actual Primary Completion Date : November 24, 2021
Estimated Study Completion Date : May 24, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma
Drug Information available for: Bimatoprost

Arm Intervention/treatment
Experimental: Bimatoprost Sustained-Release (SR)
Assigned Primary Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
Drug: Bimatoprost SR
Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

Drug: Sham Bimatoprost SR
Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

Procedure: Selective Laser Trabeculoplasty
Selective Laser Trabeculoplasty administered on Day 1.

Procedure: Sham Selective Laser Trabeculoplasty
Sham Selective Laser Trabeculoplasty administered on Day 1.

Active Comparator: Selective Laser Trabeculoplasty (SLT)
Assigned Primary Eye: SLT administered on Day 1 followed by up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16). Contralateral Eye: Sham Selective Laser Trabeculoplasty (SLT) administered on Day 1 followed by up to two Bimatoprost SR Administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).
Drug: Bimatoprost SR
Up to two Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

Drug: Sham Bimatoprost SR
Up to two Sham Bimatoprost SR administrations (Cycle 1 at Day 4 and Cycle 2 at Week 16 or at the time of the second administration for patients who receive it later than Week 16).

Procedure: Selective Laser Trabeculoplasty
Selective Laser Trabeculoplasty administered on Day 1.

Procedure: Sham Selective Laser Trabeculoplasty
Sham Selective Laser Trabeculoplasty administered on Day 1.




Primary Outcome Measures :
  1. Change from Baseline in IOP at Week 4 [ Time Frame: Baseline, Week 4 ]
  2. Change from Baseline in IOP at Week 12 [ Time Frame: Baseline, Week 12 ]
  3. Change from Baseline in Intraocular Pressure (IOP) at Week 24 [ Time Frame: Baseline, Week 24 ]

Secondary Outcome Measures :
  1. IOP change from baseline at Week 8 [ Time Frame: Baseline, Week 8 ]
  2. IOP change from baseline at Week 15 [ Time Frame: Baseline, Week 15 ]
  3. IOP change from baseline at Week 20 [ Time Frame: Baseline, Week 20 ]
  4. Time to initial use of nonstudy IOP-lowering treatment as determined by the investigator [ Time Frame: Baseline, Month 24 ]
  5. Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 4 [ Time Frame: Baseline, Week 4 ]
  6. Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 12 [ Time Frame: Baseline, Week 12 ]
  7. Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 24 [ Time Frame: Baseline, Week 24 ]
  8. Percentage of SLT eyes achieving ≥ 20% reduction at Week 4 [ Time Frame: Baseline, Week 4 ]
  9. Percentage of SLT eyes achieving ≥ 20% reduction at Week 12 [ Time Frame: Baseline, Week 12 ]
  10. Percentage of SLT eyes achieving ≥ 20% reduction at Week 24 [ Time Frame: Baseline, Week 24 ]


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:

Inclusion Criteria:

  • Diagnosis of either Open-Angle Glaucoma or Ocular Hypertension in each eye that require IOP lowering treatment.

Exclusion Criteria:

Exclusion Criteria:

  • Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
  • Previous use of commercially available Bimatoprost SR; c oncurrent enrollment in another Allergan Bimatoprost SR study; or previous enrollment in which an implant was received.

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): NCT02507687


Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02507687    
Other Study ID Numbers: 192024-093
2015-002131-18 ( EudraCT Number )
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: November 4, 2022
Last Verified: November 2022
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, analyses plans, 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 visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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