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

Phase 3

Completed

• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Interventions: Drug: SPARC0913

• Registration Number: NCT00945958
• Lead Sponsor: Sun Pharma Advanced Research Company Limited

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2009-07-23
• Study First Submitted QC: 2009-07-23
• Study First Posted: 2009-07-24
• Study Start: 2010-11
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2015-12-28
• Results First Submitted QC: 2016-04-01
• Status Verified: 2016-05
• Results First Posted: 2016-05-05
• Last Update Submitted: 2021-03-06
• Last Update Posted: 2021-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SPARC0913	SPARC0913	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With AEs	24 weeks	Subjects with treatment emergent adverse events

Secondary Outcome Measures

Name	Time	Method
Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)	24 weeks	From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured

Trial Locations

Locations (1)

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