Clinical trial NCT01223378: Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Glaucoma or Ocular Hypertension
Official title: A Randomized, Multicenter, Single-Masked, Parallel-Group Dose Finding Study Comparing the Safety and Efficacy of BOL-303259-X to Latanoprost in Subjects With Open Angle Glaucoma or Ocular Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Intraocular Pressure
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2010-10-19
Enrollment: 413
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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 appropriate dose with regard to efficacy, and ocular and systemic safety.


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.

Primary outcomes:
measure: Change in Mean Diurnal IOP at Visit 6 (Day 28)
timeFrame: Baseline and Visit 6 (Day 28)
Secondary outcomes:
measure: Change in Mean Diurnal IOP at Visits 4,5, and 7
timeFrame: Baseline and Visit 4 (Day 7), Visit 5 (day 14), and Visit 7 (Day 29)
measure: IOP </=18mm Hg
timeFrame: Visit 4 (Day 7), Visit 5 (day 14), Visit 6 (Day 28) and Visit 7 (Day 29)
measure: Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visit 6 (Day 28)
timeFrame: baseline and Visit 6 (Day 28)
measure: Change in IOP at Specified Time Points (8 AM, 12 PM, 4 PM) at Visits 4, 5, and 7 (Days 7, 14, and 29)
timeFrame: baseline and Visits 4, 5 and 7 (Days 7, 14, and 29)
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Bausch & Lomb, Inc
state: New York
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Rabia Ozden, MD
role: STUDY_DIRECTOR
References:
citation: Weinreb RN, Ong T, Scassellati Sforzolini B, Vittitow JL, Singh K, Kaufman PL; VOYAGER study group. A randomised, controlled comparison of latanoprostene bunod and latanoprost 0.005% in the treatment of ocular hypertension and open angle glaucoma: the VOYAGER study. Br J Ophthalmol. 2015 Jun;99(6):738-45. doi: 10.1136/bjophthalmol-2014-305908. Epub 2014 Dec 8.