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A single-blind , 12-week, parallel group clinical study is planned to evaluate the efficacy and safety of SPARC0912 and Reference0912. SPARC0912 is an experimental drug having similar active ingredient but containing a different preservative as that in Reference0912. Patients with open angle glaucoma or ocular hypertension will be enrolled and randomly assigned to receive either product. One drop will be instilled to the study eye nightly at 8:00 PM.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SPARC0912 | Experimental | Test drug |
|
| Reference0912 | Experimental | Reference drug |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SPARC0912 | Drug | Eye drops, once daily, 12 weeks |
| |
| Reference0912 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intraocular Pressure From Baseline to Week 12 | 95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12) | 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SPARC study site | High Point | North Carolina | 27262 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SPARC0912 | SPARC0912 administered once daily for 12 weeks |
| FG001 | Reference0912 | Reference0912 administered once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SPARC0912 | SPARC0912 administered once daily for 12 weeks |
| BG001 | Reference0912 | Reference0912 administered once daily for 12 weeks |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Change in Intraocular Pressure From Baseline to Week 12 | 95% CI for the difference between treatment groups in estimated mean change from baseline was computed for each a total of 12 time points (for the reduction in intraocular pressure from baseline to Week 12) | Intent to treat population without LOCF | Posted | Least Squares Mean | Standard Error | mm Hg | 12 weeks |
|
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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 | SPARC0912 | SPARC's formulation administered once daily for 12 weeks |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Macular edema | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| abdominal pain, colitis | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Shravanti Bhowmik | Sun Pharma Advanced Research Company | shravanti.bhowmik@sparcmail.com |
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| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| D009798 | Ocular Hypertension |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D005128 | Eye Diseases |
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| Drug |
Eye drops, once daily, 12 weeks |
|
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| OG001 | Reference0912 |
|
|
|
| 3 |
| 289 |
| 3 |
| 289 |
| EG001 | Reference0912 | Reference formulation administered once daily for 12 weeks | 5 | 289 | 4 | 289 |
| Renal failure | Renal and urinary disorders | Non-systematic Assessment |
|
| Colitis | General disorders | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | Non-systematic Assessment |
|
| Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment |
|
| Chest pain | General disorders | Non-systematic Assessment |
|
| Elevated blood pressure | Investigations | Non-systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Blood pressure increased | Investigations | Systematic Assessment |
|
| Back pain, Rotator cuff syndrome | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Renal failure | Renal and urinary disorders | Systematic Assessment |
|
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