Status:
COMPLETED
Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension
Lead Sponsor:
Bausch & Lomb Incorporated
Conditions:
Intraocular Pressure
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The objective of this clinical investigation is to determine the most effective drug concentration(s) of BOL-303259-X in the reduction of IOP in order to support further clinical development of an app...
Eligibility Criteria
Inclusion
- Subjects must have a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OH) in one or both eyes.
- IOP requirements at Visit 3, A mean/median IOP ≥ 26 mmHg at a minimum of 1 time point, ≥ 24 mmHg at a minimum of 1 time point, and ≥ 22 mmHg at 1 time point in the same eye, and Mean/median IOP ≤ 32 mmHg in both eyes at all 3 measurement time points.
- Subjects with best-corrected visual acuity (BCVA), using Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent \~20/100) or better in either eye.
Exclusion
- Subjects with a known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
- Subjects with known contraindications to nitric oxide (NO) treatment.
- Subjects whose central corneal thickness was greater than 600um in either eye.
- Subjects with any condition that prevented reliable applanation tonometry in either eye.
- Subjects with advanced glaucoma and subjects with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
- Subjects with previous or active corneal disease.
- Subjects with a history of severe dry eye.
- Subjects with monophthalmia.
- Subjects with optic disc hemorrhage.
- Subjects with a history of central retinal vein and artery occlusion.
- Subjects with a history of macular edema.
- Subjects with any intraocular infection, inflammation, or laser surgery within the previous 6 months from Visit 1 (Screening).
- Subjects who had incisional ocular surgery or severe trauma within the previous 6 months from Visit 1 (Screening).
- Subjects with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and subjects with angle closure, congenital and secondary glaucoma, and subjects with history of angle closure in either eye.
- Subjects with a diagnosis of a clinically significant or progressive retinal disease in either eye.
- Subjects who were expected to require treatment with ocular or systemic corticosteroids.
- Subjects who were in need of any other topical or systemic treatment of OAG or OHT.
- Subjects with an anticipated need to initiate or modify medication (systemic or topical) that was known to affect IOP during the study period.
Key Trial Info
Start Date :
December 13 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 22 2012
Estimated Enrollment :
413 Patients enrolled
Trial Details
Trial ID
NCT01223378
Start Date
December 13 2010
End Date
June 22 2012
Last Update
July 24 2018
Active Locations (1)
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1
Bausch & Lomb, Inc
Rochester, New York, United States, 14609