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This clinical investigation is being performed to compare the effect of BOL-303259-X dosed once daily (QD) with timolol maleate 0.5% dosed twice daily (BID) in reducing intraocular pressure (IOP) measured over a 24-hour period in subjects with open-angle glaucoma (OAG) or ocular hypertension (OHT).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Timolol Maleate | Active Comparator | Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. |
|
| BOL-303259-X | Experimental | BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BOL-303259-X | Drug | Topical ophthalmic solution |
| |
| Timolol maleate |
| Measure | Description | Time Frame |
|---|---|---|
| 24 Hour IOP | Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment | after 4 weeks of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 24-hour Ocular Perfusion Pressure | Sitting Ocular Perfusion Pressure = 95/140 x mean arterial blood pressure - IOP; Supine Ocular Perfusion Pressure = 115/130 x mean arterial blood pressure - IOP; the nocturnal time frame encompassed measures taken at 10pm, 12am, 2am and 4 am; whereas the diurnal time frame encompassed measures taken at 6am, 8am, 10am, 12pm, 2pm, 4pm, 6pm, and 8pm. | after 4 weeks of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Quintus Ngumah, OD, PhD | Bausch & Lomb Incorporated | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | La Jolla | California | 92093 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27457257 | Result | Liu JHK, Slight JR, Vittitow JL, Scassellati Sforzolini B, Weinreb RN. Efficacy of Latanoprostene Bunod 0.024% Compared With Timolol 0.5% in Lowering Intraocular Pressure Over 24 Hours. Am J Ophthalmol. 2016 Sep;169:249-257. doi: 10.1016/j.ajo.2016.04.019. Epub 2016 Jul 22. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Timolol Maleate Cross Over to BOL-303259X | Participants first recieved timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. Thereafter they received BOL-303259X once in the evening for 4 weeks. |
| FG001 | BOL-303259-X Crossover to Timolol Maleate | Participants first received BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks. Thereafter, they received timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
| |||||||||||||
| Period 2 |
|
ITT Population: All randomized subjects who received at least one dose of study drug, had a baseline and at least one postbaseline intraocular assessment.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | Participants who were randomized to receive either latanoprostene ophthalmic solution 0.024% or timolol maleate 0.5% |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | 24 Hour IOP | Supine intraocular pressure (IOP) measured in the study eye following 4 weeks of treatment | Intent to Treat (ITT) Population:All randomized subjects who received at least one dose of study drug, had a baseline and at least one postbaseline intraocular assessment. | Posted | Least Squares Mean | Standard Deviation | mm Hg | after 4 weeks of treatment |
|
Four weeks for each intervention
Safety population included all participants who received at least one dose of intervention
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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 | Timolol Maleate | Timolol maleate ophthalmic solution 0.5% administered 1 drop BID once in morning and once in the evening for 4 weeks. Timolol maleate: Topical ophthalmic solution |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Punctate keratitis | Eye disorders | MedDRA (13.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Heleen DeCory, Ph.D. | Bausch + Lomb | (585) 338-8161 | Heleen.DeCory@bausch.com |
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| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005128 | Eye Diseases |
| D005901 | Glaucoma |
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| ID | Term |
|---|---|
| C568859 | BOL 303259-X |
| D013999 | Timolol |
| ID | Term |
|---|---|
| D011412 | Propanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Drug |
Topical ophthalmic solution |
|
| IOP Area Under the Curve Over 24 Hours | The Area Under the Curve(AUC) is the weighted average of IOP over all 24-hour IOP assessment times (2pm, 4pm, 6pm, 8pm, 10pm, 12am, 2am, 4am, 6am, 8am, 10am, 12pm). The AUC was calculated using the trapezoidal rule. | after 4 weeks of treatment |
| NOT COMPLETED |
|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Treatment-Naive | Count of Participants | Participants |
|
|
|
|
| Secondary | 24-hour Ocular Perfusion Pressure | Sitting Ocular Perfusion Pressure = 95/140 x mean arterial blood pressure - IOP; Supine Ocular Perfusion Pressure = 115/130 x mean arterial blood pressure - IOP; the nocturnal time frame encompassed measures taken at 10pm, 12am, 2am and 4 am; whereas the diurnal time frame encompassed measures taken at 6am, 8am, 10am, 12pm, 2pm, 4pm, 6pm, and 8pm. | Intent to Treat (ITT): All randomized subjects who received at least one dose of study drug, had a baseline, and at least one post baseline intraocular assessment. | Posted | Mean | Standard Deviation | mm Hg | after 4 weeks of treatment |
|
|
|
|
| Secondary | IOP Area Under the Curve Over 24 Hours | The Area Under the Curve(AUC) is the weighted average of IOP over all 24-hour IOP assessment times (2pm, 4pm, 6pm, 8pm, 10pm, 12am, 2am, 4am, 6am, 8am, 10am, 12pm). The AUC was calculated using the trapezoidal rule. | ITT population | Posted | Least Squares Mean | Standard Deviation | mm Hg | after 4 weeks of treatment |
|
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 4 |
| 23 |
| EG001 | BOL-303259-X | BOL-303259-X topical ophthalmic solution administered 1 drop QD in the evening for 4 weeks. BOL-303259-X: Topical ophthalmic solution | 0 | 23 | 0 | 23 | 1 | 23 |
| Instillation site erythema | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Instillation site irritations | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dizziness | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Dyspnoea | Cardiac disorders | MedDRA (13.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (13.0) | Systematic Assessment |
|
| hyperhidrosis | General disorders | MedDRA (13.0) | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
| Heart rate decreased | Investigations | MedDRA (13.0) | Systematic Assessment |
|
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| 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 |
| OPP (Diurnal sitting) |
|