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

Primary Purpose

Open Angle Glaucoma, Ocular Hypertension

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
SPARC0913
Sponsored by
Sun Pharma Advanced Research Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring Glaucoma, Ocular hypertension

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • SPARC study site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

SPARC0913

Arm Description

Outcomes

Primary Outcome Measures

Number of Subjects With AEs
Subjects with treatment emergent adverse events

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2009
Last Updated
March 6, 2021
Sponsor
Sun Pharma Advanced Research Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT00945958
Brief Title
Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharma Advanced Research Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma, Ocular Hypertension
Keywords
Glaucoma, Ocular hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
161 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SPARC0913
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SPARC0913
Intervention Description
One drop of SPARC0913 in affected eye once daily for 24 weeks
Primary Outcome Measure Information:
Title
Number of Subjects With AEs
Description
Subjects with treatment emergent adverse events
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)
Description
From the start of study (baseline visit) through week 24 (Visit 7, end of evaluations visit), the change in IOP was measured
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
SPARC study site
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27262
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35898518
Citation
Shen Lee B, Malhotra R, Sall K, Mitchell B, Peace J. Open-Label Extension Study Comparing Latanoprost 0.005% Without vs With Benzalkonium Chloride in Open-Angle Glaucoma or Ocular Hypertension. Clin Ophthalmol. 2022 Jul 19;16:2285-2293. doi: 10.2147/OPTH.S367756. eCollection 2022.
Results Reference
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Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension

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