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Phase 3 N=161 Treatment

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

Open Angle Glaucoma · Ocular Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT00945958 ↗
Enrolled (actual)
161
Serious AEs
3.1%
Results posted
May 2016
Primary outcome: Primary: Number of Subjects With AEs — 140 participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
SPARC0913 (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Sun Pharma Advanced Research Company Limited
Primary completion
Jun 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Number of Subjects With AEs		 140 —
SECONDARY
Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)		 2.83 —

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00945958). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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