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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Timolol | Active Comparator | Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Response Rate - IOP Reduction ≥ 25% |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Vittitow | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bausch & Lomb Inc. | Rochester | New York | 14609 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26875002 | Result | 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. | |
| 29194198 | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | BOL-303259-X | BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye(s). 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). 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) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Timolol | Drug | Timolol will be administered BID once in the morning and once in the evening for 3 months (Visit 6) |
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| BOL-303259-X | Drug | 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) |
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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). |
| FG001 | Timolol | Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye(s). 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) |
| COMPLETED |
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| NOT COMPLETED |
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Intent-to-treat population. Of the 420 subjects randomized, 418 instilled at least one dose of study medication and were included in the safety population, whereas one subject did not have any post-baseline efficacy reading, hence 417 subjects were included in the Intent-to-treat population
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| ID | Title | Description |
|---|---|---|
| BG000 | BOL-303259-X | BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months (Visit 6) into the study eye during the efficacy phase, and for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase |
| BG001 | Timolol | Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months (Visit 6) into study eye. thereafter these subjects were switched to receive topical ocular BOL-303259-X QD in the evening for an additional 9 months from Visit 6 through Visit 9 (1 year) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Intent-to-treat population with LOCF | Posted | Least Squares Mean | Standard Deviation | mm Hg | 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3) |
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| 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 | Intent-to-treat population with LOCF | Posted | Count of Participants | Participants | 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3). |
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| Secondary | Response Rate - IOP Reduction ≥ 25% | Percentage of participants with IOP reduction ≥ 25% consistently at all 9 time points in the first 3 months | Intent-to-treat with LOCF | Posted | Count of Participants | Participants | 8 AM, 12 PM, and 4 PM at Visit 4(Week 2), Visit 5 (Week 6), and Visit 6 (Month 3). |
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| Other Pre-specified | 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. | Safety population (analyzed as treated). Of the 420 subjects randomized, 418 instilled at least one dose of study medication and were included in the safety population; one subject randomized to BOL-303259-X received timolol in the efficacy phase and was therefore analyzed as part of the timolol treatment group. | Posted | Count of Participants | Participants | 12 months |
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1 year
Safety Population (analyzed as treated). Of 420 subjects randomized, 418 instilled >/=1 dose and were included in the Safety Population; 1 subject randomized to BOL-303259-X received timolol and was therefore analyzed as part of the timolol group in the efficacy phase of the study. All subjects were converted to BOL-303259-X during the safety extension phase and AEs reported during that phase are presented below as a third arm
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | BOL-303259-X | BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) administered for 3 months into the study eye during the efficacy phase. | 3 | 283 | 11 | 283 | ||
| EG001 | Timolol | Timolol maleate ophthalmic solution, 0.5%, administered BID for 3 months into study eye during the efficacy phase. | 2 | 135 | 3 | 135 | ||
| EG002 | BOL-303259-X Safety Extension Phase | Following completion of the efficacy phase, all subjects were converted to BOL-303259-X ophthalmic solution QD (PM) and vehicle QD (AM) for an additional 9 months from Visit 6 through Visit 9 (1 year) during the open label safety extension phase | 8 | 385 | 5 | 385 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| torn rotator cuff | Musculoskeletal and connective tissue disorders | MedDRA v13.0 | Systematic Assessment |
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| Chest pain | Respiratory, thoracic and mediastinal disorders | MedDRA v13.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA v13.0 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
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| Spider bite | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
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| Ankle fracture | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
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| Recurrence of breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v13.0 | Systematic Assessment |
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| Allergic angioedema due to Motrin | Immune system disorders | MedDRA v13.0 | Systematic Assessment |
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| Leg disco-ordination | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
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| Aphasia | Nervous system disorders | MedDRA v13.0 | Systematic Assessment |
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| Food allergy | Immune system disorders | MedDRA v13.0 | Systematic Assessment |
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| Hydronephrosis | Renal and urinary disorders | MedDRA v13.0 | Systematic Assessment |
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| Right upper lobe lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v13.0 | Systematic Assessment |
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| Fracture of right femoral neck | Injury, poisoning and procedural complications | MedDRA v13.0 | Systematic Assessment |
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| Dislocation of intraocular lens | General disorders | MedDRA v13.0 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eye irritation | Eye disorders | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| H. DeCory, Director Medical Affairs | Bausch + Lomb, a division of Valeant Pharmaceuticals | 585 732-3284 | heleen_H_decory@bausch.com |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| C568859 | BOL 303259-X |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D020005 | Propanols |
| D000588 | Amines |
| D013830 | Thiadiazoles |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009025 | Morpholines |
| D010078 | Oxazines |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| 12 pm week 2 |
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| 4 pm week 2 |
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| 8 am week 6 |
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| 12 pm week 6 |
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| 4 pm week 6 |
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| 8 am Month 3 |
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| 12 pm Month 3 |
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| 4 pm Month 3 |
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