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NCT00945958 Clinical Trial

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

Ocular Hypertension Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00945958
Other study ID # CLR_09_13
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 2010
Est. completion date June 2012

Study information
Verified date May 2016
Source Sun Pharma Advanced Research Company Limited
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 161
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
United States SPARC study site High Point North Carolina

Sponsors (1)
Lead Sponsor Collaborator
Sun Pharma Advanced Research Company Limited

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Subjects With AEs Subjects with treatment emergent adverse events 24 weeks
Secondary 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 24 weeks
See also
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