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

Phase 3

Completed

• Conditions: Open Angle Glaucoma; Ocular Hypertension
• Interventions: Drug: SPARC0912; Drug: Reference0912

• Registration Number: NCT00947661
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-24
• Study First Posted: 2009-07-28
• Study Start: 2010-07
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Results First Submitted: 2015-12-14
• Results First Submitted QC: 2016-04-21
• Results First Posted: 2016-05-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-06
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 578

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SPARC0912	SPARC0912	Test drug
Reference0912	Reference0912	Reference drug

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

SPARC study site; 🇺🇸 High Point, North Carolina, United States