Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension

NCT07168902
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Phase
Phase 2
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Recruitment status
Completed
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Participants
252
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Lead sponsor
Bausch & Lomb Incorporated
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Start date
2025-10-24
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Number of sites
14
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Summary
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults with Primary Open Angle Glaucoma or Ocular Hypertension
clinicaltrials.gov
Short title
Phase 2 Study of BL1107 Eye Drops vs. Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension
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Official title
A Phase 2 Evaluation of the Safety, Ocular Tolerability, and Efficacy of Topical Ophthalmic BL1107 Versus Timolol in Adults With Primary Open Angle Glaucoma or Ocular Hypertension
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Completed
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-05-18
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First posted
2025-09-11
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Registry last updated
2026-07-22
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Primary completion date
2026-05-18
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Start date
2025-10-24
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Actual participants
252
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Participants
252
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Participant count basis
Actual
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Protocol amendments
1
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Number of sites
14
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Bausch & Lomb Incorporated
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07168902
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ClinicalTrials.gov ID
NCT07168902
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Change from baseline in visual field mean deviation in the study eye at Day 28/Exit.

    Timeframe: Assessed at Day 28

  1. Proportion of participants achieving ≥15-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit.

    Timeframe: Assessed at Day 28

  2. Proportion of participants achieving ≥10-letter improvement in low-luminance best-corrected visual acuity (LL-BCVA) in the study eye at Day 28/Exit.

    Timeframe: Assessed at Day 28

  3. Hour-matched change from Baseline in intraocular pressure (IOP) in the study eye at Day 28/Exit.

    Timeframe: Assessed at Day 28

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • Ocular hypertension or primary open-angle glaucoma in each eye

  • History of orthostatic hypotension
  • Any active ocular disease
  • Anticipated wearing of contact lenses during study
  • Contraindication to pupil dilation
Sources for eligibility
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  • Global Research Management, Inc.Glendale, United States
  • Eye Research FoundationNewport Beach, United States
  • California Eye Specialist Medical Group, LLCPasadena, United States
  • Eye Associates of Fort MyersFort Myers, United States
  • Levenson Eye AssociatesJacksonville, United States
  • Central Florida Eye AssociatesLakeland, United States
  • Lee Shettle Eye and HearingLargo, United States
  • Clayton Eye Clinical Research, LLCMorrow, United States
  • Coastal Research Associates, LLCRoswell, United States
  • Heart of America Eye CareShawnee Mission, United States
  • Andover Eye AssociatesAndover, United States
  • Scott & Christie and Associates, PCCranberry Township, United States
  • Total Eye Care, P.A.Memphis, United States
  • Houston Eye AssociatesHouston, United States
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)

Targets (2)