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

Ocular Hypertension Clinical Trial

— APOLLO  

Official title:

A Randomized, Multicenter, Double-Masked, Parallel-Group Study Comparing the Safety and 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: NCT01749904
• Other study ID #: 769
• Status: Completed
• Phase: Phase 3
• Start date: January 31, 2013
• Est. completion date: September 30, 2015

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: September 30, 2015
• Est. primary completion date: June 2, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

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

Intervention

Drug:
• BOL-303259-X
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).
• Timolol
Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6)
• BOL-303259-X
All participants will receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year)

Locations

Country	Name	City	State
United States	Bausch & Lomb Inc.	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View Citation

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.opht — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Ocular and Systemic Adverse Events	Following assessments through Visit 6 (Month 3), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase.	12 months
Primary	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	Response Rate - IOP = 18 mm Hg	Percentage of participants with IOP = 18 mm Hg consistently at all 9 time points in the first 3 months	8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).
Secondary	Response Rate - IOP Reduction = 25%	Percentage of participants with IOP reduction = 25% consistently at all 9 time points in the first 3 months	8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3).