Ocular Hypertension, Open Angle Glaucoma
Conditions
Keywords
glaucoma latanoprost
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.
Interventions
DRUGSPARC0912
Eye drops, once daily, 12 weeks
DRUGReference0912
Eye drops, once daily, 12 weeks
Sponsors
Sun Pharma Advanced Research Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SPARC0912 SPARC0912 administered once daily for 12 weeks | 289 |
| Reference0912 Reference0912 administered once daily for 12 weeks | 289 |
| Total | 578 |
Baseline characteristics
| Characteristic | SPARC0912 | Reference0912 | Total |
|---|---|---|---|
| Age, Continuous | 63.1 years STANDARD_DEVIATION 9.59 | 63.8 years STANDARD_DEVIATION 11.08 | 63.4 years STANDARD_DEVIATION 10.36 |
| Sex: Female, Male Female | 186 Participants | 188 Participants | 374 Participants |
| Sex: Female, Male Male | 103 Participants | 101 Participants | 204 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 289 | 4 / 289 |
| serious Total, serious adverse events | 3 / 289 | 5 / 289 |
Outcome results
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)
Time frame: 12 weeks
Population: Intent to treat population without LOCF
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| SPARC0912 | Change in Intraocular Pressure From Baseline to Week 12 | 6.12 mm Hg | Standard Error 0.23 |
| Reference0912 | Change in Intraocular Pressure From Baseline to Week 12 | 6.91 mm Hg | Standard Error 0.23 |
p-value: <0.01ANCOVA