BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension
- Conditions
- Ocular HypertensionOpen Angle Glaucoma
- Interventions
- Registration Number
- NCT01707381
- Lead Sponsor
- Bausch & Lomb Incorporated
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description BOL-303259-X BOL-303259-X BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks. Timolol Maleate Timolol maleate Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.
- Primary Outcome Measures
Name Time Method 24 Hour IOP after 4 weeks of treatment Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment
- Secondary Outcome Measures
Name Time Method 24-hour Ocular Perfusion Pressure after 4 weeks of treatment Sitting Ocular Perfusion Pressure = 95/140 x mean arterial blood pressure - IOP; Supine Ocular Perfusion Pressure = 115/130 x mean arterial blood pressure - IOP; the nocturnal time frame encompassed measures taken at 10pm, 12am, 2am and 4 am; whereas the diurnal time frame encompassed measures taken at 6am, 8am, 10am, 12pm, 2pm, 4pm, 6pm, and 8pm.
IOP Area Under the Curve Over 24 Hours after 4 weeks of treatment The Area Under the Curve(AUC) is the weighted average of IOP over all 24-hour IOP assessment times (2pm, 4pm, 6pm, 8pm, 10pm, 12am, 2am, 4am, 6am, 8am, 10am, 12pm). The AUC was calculated using the trapezoidal rule.
Trial Locations
- Locations (1)
University of California San Diego
🇺🇸La Jolla, California, United States