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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00945958
Recruitment Status : Completed
First Posted : July 24, 2009
Results First Posted : May 5, 2016
Last Update Posted : March 9, 2021
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Advanced Research Company Limited

Study Description
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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.

Condition or disease Intervention/treatment Phase
Open Angle Glaucoma Ocular Hypertension Drug: SPARC0913 Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 161 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : November 2010
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: SPARC0913 Drug: SPARC0913
One drop of SPARC0913 in affected eye once daily for 24 weeks


Outcome Measures
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Primary Outcome Measures :
  1. Number of Subjects With AEs [ Time Frame: 24 weeks ]
    Subjects with treatment emergent adverse events


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00945958


Locations
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United States, North Carolina
SPARC study site
High Point, North Carolina, United States, 27262
Sponsors and Collaborators
Sun Pharma Advanced Research Company Limited
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Sun Pharma Advanced Research Company Limited
ClinicalTrials.gov Identifier: NCT00945958    
Other Study ID Numbers: CLR_09_13
First Posted: July 24, 2009    Key Record Dates
Results First Posted: May 5, 2016
Last Update Posted: March 9, 2021
Last Verified: May 2016
Keywords provided by Sun Pharma Advanced Research Company Limited:
Glaucoma
Ocular hypertension
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Hypertension
 Vascular Diseases
Cardiovascular Diseases
Eye Diseases