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Trial record 2 of 2 for:    OTX-101 | United States

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

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ClinicalTrials.gov Identifier: NCT02688556
Recruitment Status : Completed
First Posted : February 23, 2016
Results First Posted : April 8, 2019
Last Update Posted : May 3, 2019
Sponsor:
Information provided by (Responsible Party):
Sun Pharma Global FZE

Brief Summary:
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 or disease Intervention/treatment Phase
Keratoconjunctivitis Sicca Drug: cyclosporine Drug: vehicle of OTX-101 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 745 participants
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
Actual Study Start Date : February 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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



Primary Outcome Measures :
  1. Tear Production [ Time Frame: Baseline and 12 weeks ]
    Percentage of Eyes with Increase from Baseline of ≥ 10 mm in Schirmer's Test Score


Secondary Outcome Measures :
  1. Conjunctival Staining [ Time Frame: Baseline and 12 weeks ]

    change from baseline in total conjunctival staining score (lissamine green, modified National Eye Institute scale) at 12 weeks.

    Conjunctival Lissamine Green Staining Grades ranged from 0 (No punctate stain in zone) to 3 (Densely concentrated micropunctate stain spots)


  2. Central Corneal Staining [ Time Frame: Baseline and 12 weeks ]

    change from baseline in central corneal staining score (fluorescein, modified NEI/FDA scale) at 12 weeks.

    The Expanded National Eye Institute (NEI)/Industry Workshop Scale for Corneal Staining Score was used to grade each of the 5 areas of the cornea on a 0 (No punctate stain in area) to 4 (Severe diffuse (coalescent) macropunctate stain of the area) scale.


  3. Symptom Score [ Time Frame: Baseline and 12 weeks ]

    change from baseline in modified Symptom Assessment in Dry Eye (SANDE) score at 12 weeks.

    A modified SANDE instrument was used to evaluate dry eye symptoms at each visit.

    Subjects were asked to indicate:

    1. frequency of dry and irritated eyes on a scale of 0 (rarely) to 100 (all the time); and
    2. severity of dry eyes on a scale of 0 (very mild) to 100 (severe) The global symptom score is the square root of the frequency score times the severity score and will be completed at each visit. (range 0 to 100)

    Negative change from baseline indicates improvement.




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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:

  • 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.

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
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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
Sun Pharma Global FZE

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Responsible Party: Sun Pharma Global FZE
ClinicalTrials.gov Identifier: NCT02688556     History of Changes
Other Study ID Numbers: OTX-101-2016-001
First Posted: February 23, 2016    Key Record Dates
Results First Posted: April 8, 2019
Last Update Posted: May 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sun Pharma Global FZE:
KCS
dry eye
cyclosporine
Additional relevant MeSH terms:
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Keratoconjunctivitis
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Cyclosporine
Cyclosporins
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