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

March 6, 2021 updated by: Sun Pharma Advanced Research Company Limited
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

161

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • SPARC study site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: SPARC0913
Drug: SPARC0913
One drop of SPARC0913 in affected eye once daily for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With AEs
Time Frame: 24 weeks
Subjects with treatment emergent adverse events
24 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Pharma Advanced Research Company Limited

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

June 1, 2012

Study Registration Dates

First Submitted

July 23, 2009

First Submitted That Met QC Criteria

July 23, 2009

First Posted (ESTIMATE)

July 24, 2009

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 6, 2021

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLR_09_13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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