Clinical trial NCT01707381: BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Official title: A Randomized, Single-Center, Open-Label, Crossover Study Comparing the Efficacy of BOL-303259-X Ophthalmic Solution With Timolol Maleate Ophthalmic Solution 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Hypertension
Open Angle Glaucoma
Lead sponsor: Bausch & Lomb Incorporated
Sponsor class: INDUSTRY
First posted: 2012-10-16
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).


Eligibility criteria: Inclusion Criteria:

* Subjects must have a diagnosis of OAG or OHT in 1 or both eyes.
* Subjects who are treatment-naïve must meet the following IOP requirements at Visit 1 (Screening), and pretreated subjects must meet the following IOP requirements at Visit 2 (Washout): Intraocular pressure ≥ 22 mmHg in at least 1 eye and ≤ 36 mmHg in both eyes.

Exclusion Criteria:

* Subjects who have been exposed to BOL-303259-X within 3 months prior to Visit 1 (Screening).
* Subjects with a history or presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the results of the study.
* Subjects with an irregular daily sleep schedule.
* Subjects who are unable to wear sleep monitoring device for 7 days prior to laboratory study.
* Subjects with an anticipated need to initiate or modify medication (systemic or topical) that is known to affect IOP.
* Subjects for whom concomitant use of medications may interact with the safety or efficacy of a nitric oxide.
* Subjects with known hypersensitivity or contraindications to latanoprost or any of the ingredients in the study drugs.
* Subjects who are expected to require treatment with ocular or systemic corticosteroids.
* Subjects who are in need of any other topical or systemic treatment of OAG or OHT.
* Subjects who are unable to discontinue contact lens use during and for 24 hours before the laboratory study.
* Subjects with a central corneal thickness greater than 600 μm in either eye.
* Subjects with any condition that prevents reliable applanationtonometry 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 active optic disc hemorrhage.
* Subjects with a history of central/branch retinal vein or artery occlusion.
* Subjects with a history of macular edema.
* Subjects with very narrow angles 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 with any intraocular infection or inflammation within 3 months prior to Visit 1 (Screening).
* Subjects with a history of ocular laser surgery within the 3 months prior to Visit 1 (Screening).
* Subjects with a history of incisional ocular surgery or severe trauma within 3 months prior to Visit 1 (Screening).

Primary outcomes:
measure: 24 Hour IOP
timeFrame: after 4 weeks of treatment
Secondary outcomes:
measure: 24-hour Ocular Perfusion Pressure
timeFrame: after 4 weeks of treatment
measure: IOP Area Under the Curve Over 24 Hours
timeFrame: after 4 weeks of treatment
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of California San Diego
state: California
Study officials:
affiliation: Bausch & Lomb Incorporated
name: Quintus Ngumah, OD, PhD
role: STUDY_DIRECTOR
References:
citation: Liu JHK, Slight JR, Vittitow JL, Scassellati Sforzolini B, Weinreb RN. Efficacy of Latanoprostene Bunod 0.024% Compared With Timolol 0.5% in Lowering Intraocular Pressure Over 24 Hours. Am J Ophthalmol. 2016 Sep;169:249-257. doi: 10.1016/j.ajo.2016.04.019. Epub 2016 Jul 22.