Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SPARC0912 Test drug |
Drug: SPARC0912
Eye drops, once daily, 12 weeks
|
| Experimental: Reference0912 Reference drug |
Drug: Reference0912
Eye drops, once daily, 12 weeks
|
Outcome Measures
Primary Outcome Measures
- Change in Intraocular Pressure From Baseline to Week 12 [12 weeks]
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)
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Men and women aged ≥ 18 years.
-
Diagnosis of ocular hypertension (OHT) or primary open angle glaucoma (POAG).
-
Unmedicated IOP ≥ 22 mmHg in one or both eyes.
-
Given informed consent.
-
Women of child bearing potential practicing an acceptable method of birth control with a negative urine pregnancy test.
Exclusion Criteria:
-
Known lack of ocular hypotensive response to topical ophthalmic, prostaglandin analogs (in the opinion of the investigator).
-
Intraocular conventional surgery or laser surgery within the past six months.
-
Refractive surgery in study eye (e.g., radial keratotomy, PRK, LASIK, etc.) within the past 3 months.
-
Angle closure glaucoma or a history of acute angle closure treated with a peripheral iridotomy.
-
Ocular trauma within the past 3 months.
-
Progressive retinal or optic nerve disease apart from glaucoma.
-
Concurrent infectious/non infectious conjunctivitis, keratitis, or uveitis in either eye.
-
Any abnormality preventing stable applanation tonometry.
-
Use of contact lens for the duration of the study.
-
Any opacity or subject uncooperativeness that restricts adequate examination of the ocular fundus or anterior chamber.
-
Clinically significant ocular disease (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca) which might interfere with the study, including glaucomatous damage so severe that washout of ocular hypotensive medications is not judged safe.
-
Clinically significant systemic disease which might interfere with the study.
-
History of non-compliance to medical regimens or unwilling to comply with the study protocol.
-
Participation in another clinical study within the last thirty (30) days.
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_12
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | SPARC0912 | Reference0912 |
|---|---|---|
| Arm/Group Description | SPARC0912 administered once daily for 12 weeks | Reference0912 administered once daily for 12 weeks |
| Period Title: Overall Study | ||
| STARTED | 289 | 289 |
| COMPLETED | 276 | 274 |
| NOT COMPLETED | 13 | 15 |
Baseline Characteristics
| Arm/Group Title | SPARC0912 | Reference0912 | Total |
|---|---|---|---|
| Arm/Group Description | SPARC0912 administered once daily for 12 weeks | Reference0912 administered once daily for 12 weeks | Total of all reporting groups |
| Overall Participants | 289 | 289 | 578 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
63.1
(9.59)
|
63.8
(11.08)
|
63.4
(10.36)
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
186
64.4%
|
188
65.1%
|
374
64.7%
|
| Male |
103
35.6%
|
101
34.9%
|
204
35.3%
|
Outcome Measures
| Title | Change in Intraocular Pressure From Baseline to Week 12 |
|---|---|
| Description | 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) |
| Time Frame | 12 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Intent to treat population without LOCF |
| Arm/Group Title | SPARC0912 | Reference0912 |
|---|---|---|
| Arm/Group Description | The change from baseline in intraocular pressure was calculated. A positive change from baseline suggested a reduction from baseline in intraocular pressure. Change from baseline was analyzed using an analysis of covariance methodology, a two-sided 95% CI for the difference between treatment groups in estimated mean change from baseline (i.e., LS means derived from the ANCOVA model) was computed for each time point at each visit (a total of 12 time points at 4 visits i.e. 3 time points at each visit). | |
| Measure Participants | 275 | 276 |
| Least Squares Mean (Standard Error) [mm Hg] |
6.12
(0.23)
|
6.91
(0.23)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | SPARC0912 |
|---|---|---|
| Comments | ||
| Type of Statistical Test | Non-Inferiority or Equivalence (legacy) | |
| Comments | Analysis of covariance included treatment, site, and intraocular pressure group as a covariate. Two-sided 95% confidence interval for the difference between treatment groups in estimated mean change from baseline lease square means was computed for each time point. Non-inferiority of SPARC drug relative to Reference was established if: 95% confidence interval included 0, the upper limit of the 95% CI was <1.5, and upper limit of 95% CI was <1 at most (at least 7 of 12) time point. | |
| Statistical Test of Hypothesis | p-Value | <0.01 |
| Comments | ||
| Method | ANCOVA | |
| Comments | ||
Adverse Events
| Time Frame | ||||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | SPARC0912 | Reference0912 | ||
| Arm/Group Description | SPARC's formulation administered once daily for 12 weeks | Reference formulation administered once daily for 12 weeks | ||
All Cause Mortality |
||||
| SPARC0912 | Reference0912 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| SPARC0912 | Reference0912 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/289 (1%) | 5/289 (1.7%) | ||
| Eye disorders | ||||
| Macular edema | 0/289 (0%) | 0 | 1/289 (0.3%) | 1 |
| Gastrointestinal disorders | ||||
| Abdominal pain | 0/289 (0%) | 0 | 1/289 (0.3%) | 1 |
| General disorders | ||||
| Colitis | 0/289 (0%) | 0 | 1/289 (0.3%) | 1 |
| Chest pain | 1/289 (0.3%) | 1 | 0/289 (0%) | 0 |
| Investigations | ||||
| Elevated blood pressure | 1/289 (0.3%) | 1 | 0/289 (0%) | 0 |
| Musculoskeletal and connective tissue disorders | ||||
| Rotator cuff syndrome | 0/289 (0%) | 0 | 1/289 (0.3%) | 1 |
| Back pain | 1/289 (0.3%) | 1 | 0/289 (0%) | 0 |
| Renal and urinary disorders | ||||
| Renal failure | 0/289 (0%) | 0 | 1/289 (0.3%) | 1 |
Other (Not Including Serious) Adverse Events |
||||
| SPARC0912 | Reference0912 | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 3/289 (1%) | 4/289 (1.4%) | ||
| Gastrointestinal disorders | ||||
| abdominal pain, colitis | 0/289 (0%) | 2/289 (0.7%) | ||
| General disorders | ||||
| Chest pain | 1/289 (0.3%) | 0/289 (0%) | ||
| Investigations | ||||
| Blood pressure increased | 1/289 (0.3%) | 0/289 (0%) | ||
| Musculoskeletal and connective tissue disorders | ||||
| Back pain, Rotator cuff syndrome | 1/289 (0.3%) | 1/289 (0.3%) | ||
| Renal and urinary disorders | ||||
| Renal failure | 0/289 (0%) | 1/289 (0.3%) | ||
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 | Sun Pharma Advanced Research Company |
| Phone | |
| shravanti.bhowmik@sparcmail.com |
- CLR_09_12