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An Open-Label Extension of a Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

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ClinicalTrials.gov Identifier: NCT02845674
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : September 19, 2017
Sponsor:
Information provided by (Responsible Party):
Ocular Technologies SARL

Brief Summary:
This is a safety extension enrolling subjects participating in Study OTX-101-2016-001

Condition or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: OTX-101 0.09% Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 165 participants
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
Actual Study Start Date : July 29, 2016
Actual Primary Completion Date : August 15, 2017
Actual Study Completion Date : August 15, 2017

Arm Intervention/treatment
Experimental: OTX-101 0.09%
0.09% cyclosporine nanomicellar solution
Drug: OTX-101 0.09%
0.09% cyclosporine nanomicellar solution
Other Name: Seciera




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


Information from the National Library of Medicine

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

Inclusion Criteria:

  • Completion of Study OTX-101-2016-001

Exclusion Criteria:


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.

Responsible Party: Ocular Technologies SARL
ClinicalTrials.gov Identifier: NCT02845674     History of Changes
Other Study ID Numbers: OTX-101-2016-002
First Posted: July 27, 2016    Key Record Dates
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