Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Detailed Description
This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SPARC0913
|
Drug: SPARC0913
One drop of SPARC0913 in affected eye once daily for 24 weeks
|
Outcome Measures
Primary Outcome Measures
- Number of Subjects With AEs [24 weeks]
Subjects with treatment emergent adverse events
Secondary Outcome Measures
- Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit) [24 weeks]
From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women aged ≥18 years
-
Willing to participate and giving written informed consent
-
Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation
-
Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma
Exclusion Criteria:
-
History of allergic hypersensitivity or poor tolerance to latanoprost
-
History of Substance abuse or addiction (alcohol drugs) in the past 3 years
-
History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication
-
Any abnormality preventing IOP measurement
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SPARC study site | High Point | North Carolina | United States | 27262 |
Sponsors and Collaborators
- Sun Pharma Advanced Research Company Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLR_09_13
Study Results
Participant Flow
| Recruitment Details | This study was an extension study of previous study conducted by SPARC (CLR_09_12). This was open-label, single group assignment long-term safety study. A total of 161 subjects were enrolled in this study. From the start of the study through Week 24 (Visit 7), safety endpoints (TEAEs and change introocular pressure) were evaluated |
|---|---|
| Pre-assignment Detail | Subjects received their first dose of the study drug at Visit 1 (Baseline Visit). A total of 149 subjects completed Study Visit 7 (End-of-Evaluations), which met FDA's recommendation of providing safety data for at least 100 subjects for at least 6 months. |
| Arm/Group Title | SPARC0913 |
|---|---|
| Arm/Group Description | |
| Period Title: Overall Study | |
| STARTED | 161 |
| COMPLETED | 149 |
| NOT COMPLETED | 12 |
Baseline Characteristics
| Arm/Group Title | SPARC0913 |
|---|---|
| Arm/Group Description | Inhaled dose of SPARC0913. Each single dose was administered as 1, 2, 4 and 8 puffs from the inhaler. |
| Overall Participants | 161 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
62.5
(9.4)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
56
34.8%
|
| Male |
105
65.2%
|
Outcome Measures
| Title | Number of Subjects With AEs |
|---|---|
| Description | Subjects with treatment emergent adverse events |
| Time Frame | 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | SPARC |
|---|---|
| Arm/Group Description | The number and percentage of subjects reporting a TEAE were tabulated by system organ classification and preferred terms. |
| Measure Participants | 161 |
| Number [participants] |
140
87%
|
| Title | Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit) |
|---|---|
| Description | From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured |
| Time Frame | 24 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| From the start of the study through Week 24 (Visit 7, End of Evaluations), the change in IOP is evaluated |
| Arm/Group Title | SPARC0913 |
|---|---|
| Arm/Group Description | SPARC0913: One drop of SPARC0913 in affected eye once daily for 24 weeks |
| Measure Participants | 161 |
| Mean (Standard Deviation) [mm Hg] |
2.83
(4.20)
|
Adverse Events
| Time Frame | 24 weeks | |
|---|---|---|
| Adverse Event Reporting Description | Of the 161 enrolled subjects in the study, 149 subjects received at least 24 weeks of SPARC's latanoprost treatment (completed the End-of-Evaluations i.e. Week 24), which met FDA's recommendation of providing safety data for at least 100 subjects. | |
| Arm/Group Title | SPARC0913 | |
| Arm/Group Description | From the start of the study through Week 24 (Visit 7, End of Evaluations) adverse events were evaluated | |
All Cause Mortality |
||
| SPARC0913 | ||
| Affected / at Risk (%) | # Events | |
| Total | / (NaN) | |
Serious Adverse Events |
||
| SPARC0913 | ||
| Affected / at Risk (%) | # Events | |
| Total | 5/161 (3.1%) | |
| Infections and infestations | ||
| Epididymitis orchitis | 1/161 (0.6%) | 1 |
| Nervous system disorders | ||
| Acute tension headache | 1/161 (0.6%) | 1 |
| Carotid stenosis | 1/161 (0.6%) | 1 |
| Syncopal episode | 1/161 (0.6%) | 1 |
| Vascular disorders | ||
| Peripheral vascular disease | 1/161 (0.6%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| SPARC0913 | ||
| Affected / at Risk (%) | # Events | |
| Total | 140/161 (87%) | |
| Eye disorders | ||
| Eye pain, ocular hyperemia, growh of eyelashes | 140/161 (87%) | 319 |
| Gastrointestinal disorders | ||
| Nausea | 0/161 (0%) | 0 |
| General disorders | ||
| Edema peripheral | 2/161 (1.2%) | 2 |
| Infections and infestations | ||
| Influenza, Sinusitis, Conjunctivitis viral, Tooth infection | 12/161 (7.5%) | 15 |
| Metabolism and nutrition disorders | ||
| Any PT | 2/161 (1.2%) | 5 |
| Musculoskeletal and connective tissue disorders | ||
| Osteoporosis | 3/161 (1.9%) | 3 |
| Nervous system disorders | ||
| Dizziness,Visual field defect | 6/161 (3.7%) | 7 |
| Psychiatric disorders | ||
| any PT | 1/161 (0.6%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Madarosis | 1/161 (0.6%) | 2 |
| Vascular disorders | ||
| Hypertension | 1/161 (0.6%) | 1 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Dr Shravanti Bhowmik |
|---|---|
| Organization | SPARC |
| Phone | |
| shravanti.bhowmik@sparcmail.com |
- CLR_09_13