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
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension), Ocular |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Ophthalmology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 11/23/2018 |
| Start Date: | January 2013 |
| End Date: | May 2015 |
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 3 months.
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.
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).
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