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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2012-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SPARC0913

Group Type EXPERIMENTAL

SPARC0913

Intervention Type DRUG

One drop of SPARC0913 in affected eye once daily for 24 weeks

Interventions

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SPARC0913

One drop of SPARC0913 in affected eye once daily for 24 weeks

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No