Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension

NCT01749904 | Completed Phase 3 Results

• 1 other identifier: 769
• Study Type: interventional
• Target: 420
• Locations: 1 country
• Sites: 1

Brief Summary

In participants with a diagnosis of open angle glaucoma (OAG) or ocular hypertension (OHT), the primary objective is to demonstrate that the mean IOP reduction after 3 months of treatment with BOL-303259-X once daily (QD) is non-inferior to timolol maleate 0.5% twice daily (BID). The secondary objective is to demonstrate the superiority of BOL-303259-X QD to timolol maleate 0.5% BID. This assessment will be performed if the non-inferiority of BOL-303259-X QD to timolol maleate 0.5% BID is determined. An open label safety phase will be conducted at the end of Visit 6 (3 months) where all participants will receive BOL-303259-X QD for an additional 9 months.

Conditions

Open-Angle Glaucoma; Ocular Hypertension

Keywords

Intraocular pressure

Outcome Measures

Primary Outcomes (1)

• Mean IOP

  Mean intraocular pressure (IOP) in study eye measured at the specified time points: 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).

  8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3)

Secondary Outcomes (2)

• Response Rate - IOP ≤ 18 mm Hg

  8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).

• Response Rate - IOP Reduction ≥ 25%

  8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).

Other Outcomes (1)

• Number of Participants With Ocular and Systemic Adverse Events

  12 months

Study Arms (2)

BOL-303259-X

EXPERIMENTAL

BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s).

Drug: BOL-303259-X

Timolol

ACTIVE COMPARATOR

Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s).

Drug: Timolol; Drug: BOL-303259-X

Interventions

BOL-303259-X DRUG

Topical ocular BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning for 3 months (visit 6).

BOL-303259-X

Timolol DRUG

Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)

Timolol

Eligibility Criteria

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

You may qualify if:

• Participants must have a diagnosis of OAG (including pigmentary or pseudoexfoliative) or OHT in 1 or both eyes.
• Participants must meet the following IOP requirements at Visit 3
• mean/median IOP ≥ 24 mmHg at a minimum of 2 time points in the same eye
• IOP ≤ 36 mmHg at all 3 measurement time points in both eyes.
• Participants with a best-corrected visual acuity (BCVA), using the Early Treatment of Diabetic Retinopathy Study (ETDRS) protocol, of +0.7 logMAR units (Snellen equivalent of approximately 20/100) or better in either eye.

You may not qualify if:

• Participants with known hypersensitivity or contraindications to latanoprost, NO treatment, timolol maleate, other beta-adrenergic receptor antagonists or any of the ingredients in the study drugs.
• Participants with a central corneal thickness greater than 600 μm in either eye.
• Participants with advanced glaucoma and participants with a cup/disc ratio greater than 0.8 or a history of split fixation, or a field loss threatening fixation in either eye.
• Participants who do not have an intact posterior capsule in either eye .
• Participants with aphakia in either eye.
• Participants with previous or active corneal disease in either eye.
• Participants with current or a history of severe dry eye in either eye.
• Participants with current or a history of optic disc hemorrhage in either eye.
• Participants with current or a history of central/branch retinal vein or artery occlusion in either eye.
• Participants with current or a history of macular edema in either eye.
• Participants with very narrow angles (3 quadrants with less than Grade 2 according to Shaffer's anterior chamber angle grading system) and Participants with angle closure,congenital, and secondary glaucoma, and participants with history of angle closure in either eye.
• Participants with a diagnosis of a clinically significant or progressive retinal disease in either eye.
• Participants with any intraocular infection or inflammation in either eye within 3 months(90 days) prior to Visit 1 (Screening).
• Participants with a history of ocular laser surgery in either eye within the 3 months(90 days) prior to Visit 1 (Screening).
• Participants with a history of incisional ocular surgery or severe trauma in either eye within 3 months (90 days) prior to Visit 1 (Screening).

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Inc.

Rochester, New York, 14609, United States

Location

Related Publications (2)

• Weinreb RN, Scassellati Sforzolini B, Vittitow J, Liebmann J. Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The APOLLO Study. Ophthalmology. 2016 May;123(5):965-73. doi: 10.1016/j.ophtha.2016.01.019. Epub 2016 Feb 11.

  PMID: 26875002 RESULT

• Weinreb RN, Liebmann JM, Martin KR, Kaufman PL, Vittitow JL. Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings. J Glaucoma. 2018 Jan;27(1):7-15. doi: 10.1097/IJG.0000000000000831.

  PMID: 29194198 RESULT

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Interventions

BOL 303259-X; Timolol

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

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: H. DeCory, Director Medical Affairs
• Organization: Bausch + Lomb, a division of Valeant Pharmaceuticals

heleen_H_decory@bausch.com

585 732-3284

Study Officials

• Jason Vittitow

  Bausch & Lomb Incorporated

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2012
• First Posted: December 17, 2012
• Study Start: January 31, 2013
• Primary Completion: June 2, 2015
• Study Completion: September 30, 2015
• Last Updated: November 7, 2018
• Results First Posted: November 7, 2018

Record last verified: 2018-08

Locations

US (1)