Phase 3
Completed N=420
Comparing Safety and Efficacy of BOL-303259-X With Timolol Maleate in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT01749904 ↗Enrolled (actual)
420
Serious AEs
1.6%
Results posted
Nov 2018
Primary outcomePrimary: Mean IOP — 18.61; 19.84; 18.00; 19.37 mm Hg — p=<0.01
◆ Published Evidence
Highly cited
127citations · ~13 / year
Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The APOLLO Study.
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.
Linked Publications (2)
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Latanoprostene Bunod 0.024% versus Timolol Maleate 0.5% in Subjects with Open-Angle Glaucoma or Ocular Hypertension: The APOLLO Study.
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Latanoprostene Bunod 0.024% in Subjects With Open-angle Glaucoma or Ocular Hypertension: Pooled Phase 3 Study Findings.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean IOP |
18.61; 19.84; 18.00; 19.37; 18.09; 19.20 | <0.01 sig |
| SECONDARY Response Rate - IOP ≤ 18 mm Hg |
65; 15 | 0.005 sig |
| SECONDARY Response Rate - IOP Reduction ≥ 25% |
99; 26 | 0.001 sig |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT01749904) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.