Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension

Sun Pharma Advanced Research (SPARC)

Status and phase: Completed; Phase 3

Conditions: Open Angle Glaucoma; Ocular Hypertension

Treatments: Drug: SPARC0913

Study type: Interventional

Funder types: Industry

Identifiers

NCT00945958

CLR_09_13

Details and patient eligibility

About

The purpose of this study is to evaluate the long-term safety of SPARC0913. A multicenter, open label, non-randomized, uncontrolled, single group assignment, safety study of subjects with primary open angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.

Full description

This is a multicenter, open label, non-randomized, single-arm, extension safety study to evaluate the long-term safety of SPARC0913. Subjects who completed the prior evaluator-masked clinical non-inferiority Study participated in the current study.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women aged ≥18 years
• Willing to participate and giving written informed consent
• Willing to commit to study medication-dosing, study visits and follow-up visits to complete evaluation
• Eligible to receive Latanoprost once a daily as monotherapy for treatment of glaucoma

Exclusion criteria

• History of allergic hypersensitivity or poor tolerance to latanoprost
• History of Substance abuse or addiction (alcohol drugs) in the past 3 years
• History of chronic use of concomitant medications in neurologic or psychiatric illness that would affect assessment of safety and effectiveness of the study medication
• Any abnormality preventing IOP measurement

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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161 participants in 1 patient group

SPARC0913

Experimental group

Treatment:

Drug: SPARC0913