Status:
COMPLETED
Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
Lead Sponsor:
Sun Pharma Advanced Research Company Limited
Conditions:
Open Angle Glaucoma
Ocular Hypertension
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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...
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-infe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
161 Patients enrolled
Trial Details
Trial ID
NCT00945958
Start Date
November 1 2010
End Date
June 1 2012
Last Update
March 9 2021
Active Locations (1)
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1
SPARC study site
High Point, North Carolina, United States, 27262