Efficacy and Safety of SPARC0912 and Reference0912 in Open Angle Glaucoma or Ocular Hypertension

Study Overview
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Brief Summary
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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.

Conditions
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Open Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
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* Drug: SPARC0912
* Drug: Reference0912


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPARC0912<br>Test drug | Drug: SPARC0912<br>* Eye drops, once daily, 12 weeks<br>|
| Experimental: Reference0912<br>Reference drug | Drug: Reference0912<br>* Eye drops, once daily, 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma latanoprost