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Comparison of Bimatoprost SR to Selective Laser Trabeculoplasty in Patients With Open-Angle Glaucoma or Ocular Hypertension

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ClinicalTrials.gov Identifier: NCT02507687
Recruitment Status : Recruiting
First Posted : July 24, 2015
Last Update Posted : December 18, 2018
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 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
Estimated Primary Completion Date : December 28, 2019
Estimated Study Completion Date : December 28, 2020

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 B 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 B 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 B 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 B 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 time-weighted average through Week 24 [ Time Frame: Baseline, Week 24 ]
  2. IOP change from baseline at Week 8 [ Time Frame: Baseline, Week 8 ]
  3. IOP change from baseline at Week 15 [ Time Frame: Baseline, Week 15 ]
  4. IOP change from baseline at Week 20 [ Time Frame: Baseline, Week 20 ]
  5. IOP at each visit [ Time Frame: 24 Weeks ]
  6. Time to onset of effect (time to first achieving [ Time Frame: Baseline, Week 52 ]
  7. Time to initial use of nonstudy IOP-lowering treatment as determined by the investigator [ Time Frame: Baseline, Week 52 ]
  8. Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 4 [ Time Frame: Baseline, Week 4 ]
  9. Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 12 [ Time Frame: Baseline, Week 12 ]
  10. Percentage of Bimatoprost SR eyes achieving ≥ 20% reduction at Week 24 [ Time Frame: Baseline, Week 24 ]
  11. Percentage of SLT eyes achieving ≥ 20% reduction at Week 4 [ Time Frame: Baseline, Week 4 ]
  12. Percentage of SLT eyes achieving ≥ 20% reduction at Week 12 [ Time Frame: Baseline, Week 12 ]
  13. Percentage of SLT eyes achieving ≥ 20% reduction at Week 24 [ Time Frame: Baseline, Week 24 ]


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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): NCT02507687


Contacts
Contact: Clinical Trials Registry Team 1-800-347-4500 IR-CTRegistration@allergan.com

  Show 84 Study Locations
Sponsors and Collaborators
Allergan
Investigators
Study Director: Marina Bejanian Allergan

Additional Information:
Responsible Party: Allergan
ClinicalTrials.gov Identifier: NCT02507687     History of Changes
Other Study ID Numbers: 192024-093
2015-002131-18 ( EudraCT Number )
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: December 18, 2018
Last Verified: December 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Hypertension
Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Vascular Diseases
Cardiovascular Diseases
Eye Diseases
Bimatoprost
Antihypertensive Agents