We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 2 of 2 for:    Seciera

Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca (Emerald)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02688556
First Posted: February 23, 2016
Last Update Posted: February 17, 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 randomized, double-masked, vehicle-controlled study of the safety and efficacy of OTX-101 (0.09% cyclosporine nanomicellar solution) in the treatment of keratoconjunctivitis sicca to be conducted at approximately 50 sites.

Condition Intervention Phase
Keratoconjunctivitis Sicca Drug: cyclosporine Drug: vehicle of OTX-101 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Double-Masked, Vehicle-Controlled Study of the Safety and Efficacy of OTX-101 in the Treatment of Keratoconjunctivitis Sicca

Resource links provided by NLM:


Further study details as provided by Ocular Technologies SARL:

Primary Outcome Measures:
  • Tear Production [ Time Frame: 12 weeks ]
    Proportion of subjects with a clinically meaningful increase from baseline in Schirmer's test at 12 weeks


Secondary Outcome Measures:
  • Conjunctival Staining [ Time Frame: 12 weeks ]
    change from baseline in total conjunctival staining score (lissamine green, modified NEI/FDA scale) at 12 weeks

  • Central corneal staining [ Time Frame: 12 weeks ]
    change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks

  • Symptom Score [ Time Frame: 12 weeks ]
    change from baseline in modified SANDE score at 12 weeks


Enrollment: 745
Actual Study Start Date: February 2016
Study Completion Date: December 2016
Primary Completion Date: November 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: OTX-101 0.09%
0.09% cyclosporine nanomicellar ophthalmic solution
Drug: cyclosporine
Other Name: Seciera
Placebo Comparator: Vehicle
vehicle of OTX-101
Drug: vehicle of OTX-101

  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:

  • History of dry eye syndrome (KCS) for a period of at least 6 months
  • Clinical diagnosis of bilateral KCS
  • Lissamine green conjunctival staining sum score of ≥ 3 to ≤ 9 out of a total possible score of 12 (scoring excludes superior zones 2 and 4) in the same eye at both the Screening and Baseline Visits.
  • Global symptom score (SANDE) ≥ 40 mm at both the Screening and Baseline Visits
  • Corrected Snellen visual acuity (VA) of better than 20/200 in each eye.

Exclusion Criteria:

  • Use of cyclosporine ophthalmic emulsion 0.05% (Restasis®) within 3 months prior to the Screening Visit.
  • Previous treatment failure (lack of efficacy) with cyclosporine ophthalmic emulsion 0.05% (Restasis).
  • Diagnosis of Sjögren's disease ˃ 5 years prior to the Screening Visit.
  • Clinical diagnosis or any history of seasonal and/or perennial allergic conjunctivitis.
  • Use of systemic or topical medications within 7 days prior to the Screening Visit or during the study period that are known to cause dry eye.
  • Use of any topical ophthalmic medications, prescription (including anti-glaucoma medications) or over the counter (including artificial tears), other than the assigned study medication during the study period.
  • Current active eye disease other than dry wyw syndrome (i.e., any disease for which topical or systemic ophthalmic medication is necessary).
  • History of herpes keratitis.
  • Corneal transplant
  • Corneal refractive surgery within 6 months prior to the Screening Visit or postoperative refractive surgery symptoms of dryness that have not resolved.
  • Cataract surgery within 3 months prior to the Screening Visit.
  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): NCT02688556


Locations
United States, California
Martel Eye Medical Group
Rancho Cordova, California, United States, 95670
United States, Kentucky
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
United States, New York
Fifth Avenue Eye Associates
New York, New York, United States, 10028
Sponsors and Collaborators
Ocular Technologies SARL
Investigators
Study Director: Tomasz Sablinski, MD, PhD Ocular Therapeutics SARL
  More Information

Responsible Party: Ocular Technologies SARL
ClinicalTrials.gov Identifier: NCT02688556     History of Changes
Other Study ID Numbers: OTX-101-2016-001
First Submitted: February 13, 2016
First Posted: February 23, 2016
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ocular Technologies SARL:
KCS
dry eye
cyclosporine

Additional relevant MeSH terms:
Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporins
Cyclosporine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents
Calcineurin Inhibitors