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

Ocular Hypertension Clinical Trial

— LUNAR  

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: NCT01749930
• Other study ID #: 770
• Status: Completed
• Phase: Phase 3
• Start date: January 2013
• Est. completion date: May 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 3 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: May 2015
• Est. primary completion date: May 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
BOL-303259-X will be administered QD in the evening and its vehicle administered QD in the morning
• Timolol
Timolol will be administered BID once in the morning and once in the evening.
• BOL-303259-X
All participants will receive a topical ocular BOL-303259-X QD in the evening from 3 months (Visit 6) through 6 months (Visit7).

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)

Medeiros FA, Martin KR, Peace J, Scassellati Sforzolini B, Vittitow JL, Weinreb RN. Comparison of Latanoprostene Bunod 0.024% and Timolol Maleate 0.5% in Open-Angle Glaucoma or Ocular Hypertension: The LUNAR Study. Am J Ophthalmol. 2016 Aug;168:250-259. d — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Ocular and Systemic Adverse Events	Following assessments through 3 months (Visit 6), all participants, irrespective of previous randomization, converted to a single open label safety arm receiving BOL-303259-X QD in the evening for an additional 3 months through Visit 7. Adverse events were recorded throughout the comparative efficacy phase and open label extension phase.	6 months
Primary	Mean IOP	Mean intraocular pressure (IOP) in the 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	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	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)