BOL-303259-X With Timolol 0.5% in Subjects With Open-Angle Glaucoma or Ocular Hypertension

Ocular Hypertension Clinical Trial

— Constellation  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01707381
• Other study ID #: 803
• Status: Completed
• Phase: Phase 2
• Start date: November 2012
• Est. completion date: February 2014

Study information

• Verified date: August 2018
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: February 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 90 Years

Eligibility

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).

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Drug:
• BOL-303259-X
Topical ophthalmic solution
• Timolol maleate
Topical ophthalmic solution

Locations

Country	Name	City	State
United States	University of California San Diego	La Jolla	California

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24 Hour IOP	Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment	after 4 weeks of treatment
Secondary	24-hour Ocular Perfusion Pressure	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.	after 4 weeks of treatment
Secondary	IOP Area Under the Curve Over 24 Hours	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.	after 4 weeks of treatment