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OpenTrials
Completed

NCT Number: NCT00945958

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

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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Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

SPARC study site

High Point, North Carolina, 27262, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SPARC0913

Drug

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

Primary outcomes

  1. Number of Subjects With AEs

    Time frame: 24 weeks

    Subjects with treatment emergent adverse events

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Sun Pharma Advanced Research Company Limited

Industry

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 24, 2009
Registry last updated
Mar 9, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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