Phase 3
Completed N=161
Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
Source: ClinicalTrials.gov NCT00945958 ↗Enrolled (actual)
161
Serious AEs
3.1%
Results posted
May 2016
Primary outcomePrimary: Number of Subjects With AEs — 140 participants
◆ Published Evidence
Emerging
10citations · ~3 / year
Open-Label Extension Study Comparing Latanoprost 0.005% Without vs With Benzalkonium Chloride in Open-Angle Glaucoma or Ocular Hypertension.
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.
Linked Publications
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Open-Label Extension Study Comparing Latanoprost 0.005% Without vs With Benzalkonium Chloride in Open-Angle Glaucoma or Ocular Hypertension.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With AEs |
140 | — |
| SECONDARY Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit) |
2.83 | — |
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
Data sourced from ClinicalTrials.gov (NCT00945958) and the linked publication. 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. Informational only — not medical advice.