Evaluation of Safety of SPARC0913 in Open Angle Glaucoma or Ocular Hypertension
1 other identifier
interventional
161
1 country
1
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 angle glaucoma or ocular hypertension is planned. Subjects will receive study medication for a period of 24-weeks.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 23, 2009
CompletedFirst Posted
Study publicly available on registry
July 24, 2009
CompletedStudy Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2012
CompletedResults Posted
Study results publicly available
May 5, 2016
CompletedMarch 9, 2021
May 1, 2016
1.6 years
July 23, 2009
December 28, 2015
March 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Subjects With AEs
Subjects with treatment emergent adverse events
24 weeks
Secondary Outcomes (1)
Mean Change in IOP From Baseline to Visit 7 (End of Evaluations Visit)
24 weeks
Study Arms (1)
SPARC0913
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
SPARC study site
High Point, North Carolina, 27262, United States
Related Publications (1)
Shen Lee B, Malhotra R, Sall K, Mitchell B, Peace J. Open-Label Extension Study Comparing Latanoprost 0.005% Without vs With Benzalkonium Chloride in Open-Angle Glaucoma or Ocular Hypertension. Clin Ophthalmol. 2022 Jul 19;16:2285-2293. doi: 10.2147/OPTH.S367756. eCollection 2022.
PMID: 35898518DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Shravanti Bhowmik
- Organization
- SPARC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 23, 2009
First Posted
July 24, 2009
Study Start
November 1, 2010
Primary Completion
June 1, 2012
Study Completion
June 1, 2012
Last Updated
March 9, 2021
Results First Posted
May 5, 2016
Record last verified: 2016-05