Clinical Trials Directory

A Randomized, Multicenter, Double-Masked, Parallel-Group Study Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension.

In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 9 months.

Stanford is not currently accepting new patients for this trial. You may want to check to see if other locations are recruiting.



  • drug : BOL-303259-X
  • drug : BOL-303259-X
  • drug : Timolol

Phase: Phase 3


Ages Eligible For Study:

18 Years - N/A

Inclusion Criteria

- Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes. - Participants must meet the following IOP requirements at Visit 3 - mean/median IOP ? 24 mmHg at a minimum of 2 time points in the same eye - IOP ? 36 mmHg at all 3 measurement time points in both eyes. - Participants with a best-corrected visual acuity (BCVA), using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent of approximately 20/100) or better in either eye.

External Links

Contact information

Primary Contact:

Zayna Shaheen 650 497-9205

Stanford University School of Medicine 300 Pasteur Drive Stanford, CA 94305

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