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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01707381
Other study ID # 803
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
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
Health authority
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).

Study Design


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
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