Trial Search Results

Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate 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 currently not accepting patients for this trial.

Lead Sponsor:

Bausch & Lomb Incorporated

Stanford Investigator(s):

Intervention(s):

  • Drug: BOL-303259-X
  • Drug: Timolol
  • Drug: BOL-303259-X

Phase:

Phase 3

Eligibility


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.

Exclusion Criteria:

   - Participants with known hypersensitivity or contraindications to latanoprost, NO
   treatment, timolol maleate, other beta-adrenergic receptor antagonists or any of the
   ingredients in the study drugs.

   - Participants with a central corneal thickness greater than 600 μm in either eye.

   - Participants with advanced glaucoma and participants with a cup/disc ratio greater
   than 0.8 or a history of split fixation, or a field loss threatening fixation in
   either eye.

   - Participants who do not have an intact posterior capsule in either eye .

   - Participants with aphakia in either eye.

   - Participants with previous or active corneal disease in either eye.

   - Participants with current or a history of severe dry eye in either eye.

   - Participants with current or a history of optic disc hemorrhage in either eye.

   - Participants with current or a history of central/branch retinal vein or artery
   occlusion in either eye.

   - Participants with current or a history of macular edema in either eye.

   - Participants with very narrow angles (3 quadrants with less than Grade 2 according to
   Shaffer's anterior chamber angle grading system) and Participants with angle
   closure,congenital, and secondary glaucoma, and participants with history of angle
   closure in either eye.

   - Participants with a diagnosis of a clinically significant or progressive retinal
   disease in either eye.

   - Participants with any intraocular infection or inflammation in either eye within 3
   months(90 days) prior to Visit 1 (Screening).

   - Participants with a history of ocular laser surgery in either eye within the 3
   months(90 days) prior to Visit 1 (Screening).

   - Participants with a history of incisional ocular surgery or severe trauma in either
   eye within 3 months (90 days) prior to Visit 1 (Screening).

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Zayna Shaheen
650 497-9205
Not Recruiting