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

NCT01707381 | Completed Phase 2 Results

• 1 other identifier: 803
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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).

Conditions

Ocular Hypertension; Open Angle Glaucoma

Outcome Measures

Primary Outcomes (1)

• 24 Hour IOP

  Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment

  after 4 weeks of treatment

Secondary Outcomes (2)

• 24-hour Ocular Perfusion Pressure

  after 4 weeks of treatment

• IOP Area Under the Curve Over 24 Hours

  after 4 weeks of treatment

Study Arms (2)

Timolol Maleate

ACTIVE COMPARATOR

Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks.

Drug: Timolol maleate

BOL-303259-X

EXPERIMENTAL

BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks.

Drug: BOL-303259-X

Interventions

BOL-303259-X DRUG

Topical ophthalmic solution

BOL-303259-X

Timolol maleate DRUG

Topical ophthalmic solution

Timolol Maleate

Eligibility Criteria

• Age: 40 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

University of California San Diego

La Jolla, California, 92093, United States

Location

Related 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. Epub 2016 Jul 22.

  PMID: 27457257 RESULT

MeSH Terms

Conditions

Ocular Hypertension; Glaucoma, Open-Angle

Interventions

BOL 303259-X; Timolol

Condition Hierarchy (Ancestors)

Eye Diseases; Glaucoma

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Thiadiazoles; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Morpholines; Oxazines

Results Point of Contact

• Title: Heleen DeCory, Ph.D.
• Organization: Bausch + Lomb

Heleen.DeCory@bausch.com

(585) 338-8161

Study Officials

• Quintus Ngumah, OD, PhD

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2012
• First Posted: October 16, 2012
• Study Start: November 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: September 4, 2018
• Results First Posted: September 4, 2018

Record last verified: 2018-08

Locations

US (1)