An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
An Open-Label Extension of a Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
1 other identifier
interventional
258
0 countries
N/A
Brief Summary
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2016
Shorter than P25 for phase_3
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 24, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedStudy Start
First participant enrolled
July 29, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2017
CompletedResults Posted
Study results publicly available
December 14, 2018
CompletedNovember 19, 2021
November 1, 2021
1 year
July 24, 2016
November 14, 2018
November 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Adverse Events
Number of subjects reporting any AEs
40 weeks
Study Arms (1)
OTX-101 0.09%
EXPERIMENTAL0.09% cyclosporine nanomicellar solution
Interventions
Eligibility Criteria
You may qualify if:
- Completion of Study OTX-101-2016-001
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Sheppard J, Bergmann M, Schechter BA, Luchs J, Ogundele A, Karpecki P. Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca. Clin Ophthalmol. 2021 Jan 12;15:129-140. doi: 10.2147/OPTH.S279364. eCollection 2021.
PMID: 33469259DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- SPARC
- Organization
- Sun Pharma Advanced Research Company Limited
Publication Agreements
- PI is Sponsor Employee
- No
- 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 24, 2016
First Posted
July 27, 2016
Study Start
July 29, 2016
Primary Completion
August 15, 2017
Study Completion
August 15, 2017
Last Updated
November 19, 2021
Results First Posted
December 14, 2018
Record last verified: 2021-11