Phase 2
Completed N=413
Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension
Intraocular Pressure
Source: ClinicalTrials.gov NCT01223378 ↗
Enrolled (actual)
413
Serious AEs
0.7%
Results posted
Jul 2018
Primary outcomePrimary: Change in Mean Diurnal IOP at Visit 6 (Day 28) — -7.829; -8.295; -8.952; -8.894 mm Hg
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 appropriate dose with regard to efficacy, and ocular and systemic safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Mean Diurnal IOP at Visit 6 (Day 28) |
-7.829; -8.295; -8.952; -8.894; -7.800 | — |
| SECONDARY Change in Mean Diurnal IOP at Visits 4,5, and 7 |
-6.850; -7.707; -8.230; -8.456; -7.325; -7.607 | — |
| SECONDARY IOP </=18mm Hg |
30; 37; 47; 46; 29; 34 | — |
| SECONDARY Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28) |
-8.42; -8.91; -9.46; -9.61; -8.76; -7.82 | — |
| SECONDARY Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29) |
-7.203; -8.396; -8.667; -8.869; -8.125; -6.665 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT01223378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.