Comparing the Safety and Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Last updated: October 25, 2018
Sponsor: Bausch & Lomb Incorporated
Overall Status: Completed

Phase

3

Condition

Ocular Hypertension

Glaucoma

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT01749930
770
  • Ages > 18
  • All Genders

Study Summary

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 3 months.

Eligibility Criteria

Inclusion

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 ofDiabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalentof approximately 20/100) or better in either eye.

Exclusion

Exclusion Criteria:

  • Participants with known hypersensitivity or contraindications to latanoprost, NOtreatment, timolol maleate, other beta-adrenergic receptor antagonists or any of theingredients 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 greaterthan 0.8 or a history of split fixation, or a field loss threatening fixation ineither 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 arteryocclusion 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 toShaffer's anterior chamber angle grading system) and participants with angleclosure,congenital, and secondary glaucoma, and participants with history of angleclosure in either eye.

  • Participants with a diagnosis of a clinically significant or progressive retinaldisease in either eye.

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

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

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

Study Design

Total Participants: 420
Study Start date:
January 01, 2013
Estimated Completion Date:
May 31, 2015

Connect with a study center

  • Bausch & Lomb Inc.

    Rochester, New York 14609
    United States

    Site Not Available

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