ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

Last updated: March 9, 2023
Sponsor: Novaliq GmbH
Overall Status: Completed

Phase

3

Condition

Sjogren's Syndrome

Dry Eyes

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT04523129
CYS-004
  • Ages > 18
  • All Genders

Study Summary

The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed ICF (Informed Consent Form)
  • Patient-reported history of DED in both eyes
  • Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms
  • Ability and willingness to follow instructions, including participation in all studyassessments and visits

Exclusion

Exclusion Criteria:

  • Women who are pregnant, nursing or planning a pregnancy
  • Unwillingness to submit a urine pregnancy test at screening and the last visit (orearly termination visit) if of childbearing potential, or unwillingness to useacceptable means of birth control
  • Clinically significant slit-lamp findings or abnormal lid anatomy at screening
  • Ocular/periocular malignancy
  • History of herpetic keratitis
  • Active ocular allergies or ocular allergies that may become active during the studyperiod
  • Ongoing ocular or systemic infection at screening or baseline
  • Wear of contact lenses within 3 months prior to screening or anticipated use ofcontact lenses during the study
  • Use of topical Cyclosporine A or Liftigrast within 2 months prior to screening
  • Intraocular surgery or ocular laser surgery within the previous 6 months, or have anyplanned ocular and/or lid surgeries over the study period
  • Presence of uncontrolled systemic diseases
  • Presence of known allergy and/or sensitivity to the study drug or its components
  • Randomized in a previous CyclASol trial

Study Design

Total Participants: 834
Study Start date:
December 05, 2020
Estimated Completion Date:
October 08, 2021

Study Description

This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.

Connect with a study center

  • CYS-004 Investigational Site

    Phoenix, Arizona 85032
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Los Angeles, California 90013
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Newport Beach, California 92663
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Santa Ana, California 92705
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Colorado Springs, Colorado 80907
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Fort Lauderdale, Florida 33309
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Chicago, Illinois 60619
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Carmel, Indiana 46290
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Indianapolis, Indiana 46240
    United States

    Site Not Available

  • CYS-004 Investigational site

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Raynham, Massachusetts 02767
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Medina, Minnesota 55364
    United States

    Site Not Available

  • CYS-004 Investigation Site

    Kansas City, Missouri 64154
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Henderson, Nevada 89052
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Raleigh, North Carolina 27603
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Shelby, North Carolina 28150
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Fargo, North Dakota 58103
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Cranberry Township, Pennsylvania 16066
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Warwick, Rhode Island 02886
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Smyrna, Tennessee 37167
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Layton, Utah 84041
    United States

    Site Not Available

  • CYS-004 Investigational site

    Ogden, Utah 84403
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Lynchburg, Virginia 24502
    United States

    Site Not Available

  • CYS-004 Investigational Site

    Seattle, Washington 98119
    United States

    Site Not Available

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