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Trial record 1 of 2 for:    Seciera
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An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02845674
First Posted: July 27, 2016
Last Update Posted: September 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ocular Technologies SARL
July 24, 2016
July 27, 2016
September 19, 2017
July 29, 2016
August 15, 2017   (Final data collection date for primary outcome measure)
adverse events [ Time Frame: 40 weeks ]
Same as current
Complete list of historical versions of study NCT02845674 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001
Not Provided
Interventional
Phase 3
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Keratoconjunctivitis Sicca
Drug: OTX-101 0.09%
0.09% cyclosporine nanomicellar solution
Other Name: Seciera
Experimental: OTX-101 0.09%
0.09% cyclosporine nanomicellar solution
Intervention: Drug: OTX-101 0.09%
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
August 15, 2017
August 15, 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Completion of Study OTX-101-2016-001

Exclusion Criteria:

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT02845674
OTX-101-2016-002
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Undecided
Ocular Technologies SARL
Ocular Technologies SARL
Not Provided
Study Director: Tomasz Sablinski, MD, PhD CT Development America, Inc.
Ocular Technologies SARL
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP