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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
  Purpose
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001

Condition Intervention Phase
Keratoconjunctivitis Sicca Drug: OTX-101 0.09% Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Further study details as provided by Ocular Technologies SARL:

Primary Outcome Measures:
  • adverse events [ Time Frame: 40 weeks ]

Enrollment: 165
Actual Study Start Date: July 29, 2016
Study Completion Date: August 15, 2017
Primary Completion Date: August 15, 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OTX-101 0.09%
0.09% cyclosporine nanomicellar solution
Drug: OTX-101 0.09%
0.09% cyclosporine nanomicellar solution
Other Name: Seciera

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Completion of Study OTX-101-2016-001

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02845674


Sponsors and Collaborators
Ocular Technologies SARL
Investigators
Study Director: Tomasz Sablinski, MD, PhD CT Development America, Inc.
  More Information

Responsible Party: Ocular Technologies SARL
ClinicalTrials.gov Identifier: NCT02845674     History of Changes
Other Study ID Numbers: OTX-101-2016-002
First Submitted: July 24, 2016
First Posted: July 27, 2016
Last Update Posted: September 19, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases