Back to resultsAn Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Primary Purpose
Keratoconjunctivitis Sicca
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
OTX-101 0.09%
Sponsored by
About this trial
This is an interventional treatment trial for Keratoconjunctivitis Sicca
Eligibility Criteria
Inclusion Criteria:
- Completion of Study OTX-101-2016-001
Exclusion Criteria:
-
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OTX-101 0.09%
Arm Description
0.09% cyclosporine nanomicellar solution
Outcomes
Primary Outcome Measures
Adverse Events
Number of subjects reporting any AEs
Secondary Outcome Measures
Full Information
NCT ID
NCT02845674
First Posted
July 24, 2016
Last Updated
November 18, 2021
Sponsor
Sun Pharmaceutical Industries Limited
1. Study Identification
Unique Protocol Identification Number
NCT02845674
Brief Title
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
July 29, 2016 (Actual)
Primary Completion Date
August 15, 2017 (Actual)
Study Completion Date
August 15, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001 (NCT02688556)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Keratoconjunctivitis Sicca
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
258 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OTX-101 0.09%
Arm Type
Experimental
Arm Description
0.09% cyclosporine nanomicellar solution
Intervention Type
Drug
Intervention Name(s)
OTX-101 0.09%
Other Intervention Name(s)
Seciera
Intervention Description
0.09% cyclosporine nanomicellar solution
Primary Outcome Measure Information:
Title
Adverse Events
Description
Number of subjects reporting any AEs
Time Frame
40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Completion of Study OTX-101-2016-001
Exclusion Criteria:
-
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33469259
Citation
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.
Results Reference
derived
Learn more about this trial
An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
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