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

NCT ID: NCT00947661

Last Updated: 2021-03-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 578 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-07-31
• Study Completion Date: 2012-05-31

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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

SPARC0912

Test drug

Group Type: EXPERIMENTAL

SPARC0912

Intervention Type: DRUG

Eye drops, once daily, 12 weeks

Reference0912

Reference drug

Group Type: EXPERIMENTAL

Reference0912

Intervention Type: DRUG

Eye drops, once daily, 12 weeks

Interventions

SPARC0912

Eye drops, once daily, 12 weeks

Intervention Type: DRUG

Reference0912

Eye drops, once daily, 12 weeks

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Pharma Advanced Research Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

SPARC study site

High Point, North Carolina, United States

Countries

United States

Other Identifiers

CLR_09_12

Identifier Type: -

Identifier Source: org_study_id