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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
February 13, 2016
February 23, 2016
February 17, 2017
February 2016
November 2016   (Final data collection date for primary outcome measure)
Tear Production [ Time Frame: 12 weeks ]
Proportion of subjects with a clinically meaningful increase from baseline in Schirmer's test at 12 weeks
Same as current
Complete list of historical versions of study NCT02688556 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Phase 3 Study of OTX-101 in the Treatment of Keratoconjunctivitis Sicca
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 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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Keratoconjunctivitis Sicca
  • Drug: cyclosporine
    Other Name: Seciera
  • Drug: vehicle of OTX-101
  • Experimental: OTX-101 0.09%
    0.09% cyclosporine nanomicellar ophthalmic solution
    Intervention: Drug: cyclosporine
  • Placebo Comparator: Vehicle
    vehicle of OTX-101
    Intervention: Drug: vehicle of OTX-101
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
745
December 2016
November 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02688556
OTX-101-2016-001
No
Not Provided
Plan to Share IPD: Undecided
Ocular Technologies SARL
Ocular Technologies SARL
Not Provided
Study Director: Tomasz Sablinski, MD, PhD Ocular Therapeutics SARL
Ocular Technologies SARL
February 2017

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