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A 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: NCT02636946
Recruitment Status : Active, not recruiting
First Posted : December 22, 2015
Last Update Posted : July 7, 2020
Sponsor:
Information provided by (Responsible Party):
Allergan

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 144 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 : February 24, 2016
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : February 28, 2021

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 three Bimatoprost SR Dose A administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR Dose A administrations at Day 4 and Week 16 (Stage 2).

Contralateral Eye: SLT administered on Day 1 followed by up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

Drug: Bimatoprost SR
Up to three Bimatoprost SR Dose A administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR Dose A administrations at Day 4 and Week 16 (Stage 2).

Drug: Sham Bimatoprost SR
Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

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 three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

Contralateral Eye: Sham SLT administered on Day 1 followed by up to three Bimatoprost SR Dose A administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR Dose A administrations at Day 4 and Week 16 (Stage 2).

Drug: Bimatoprost SR
Up to three Bimatoprost SR Dose A administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Bimatoprost SR Dose A administrations at Day 4 and Week 16 (Stage 2).

Drug: Sham Bimatoprost SR
Up to three Sham Bimatoprost SR administrations at Day 4, Weeks 16 and 32 (Stage 1) or two Sham Bimatoprost SR administrations at Day 4 and Week 16 (Stage 2).

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

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, Week 52 ]
  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

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

Exclusion Criteria:

  • Eye surgery (including cataract surgery) and or eye laser surgery within the past 6 months.
  • Enrollment in other studies using Bimatoprost SR.

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): NCT02636946


Locations
Show Show 58 study locations
Sponsors and Collaborators
Allergan
Investigators
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Study Director: Margot Goodkin Allergan
Additional Information:
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Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02636946    
Other Study ID Numbers: 192024-095
2015-003631-34 ( EudraCT Number )
First Posted: December 22, 2015    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: July 2020

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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