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

Last updated: December 21, 2022
Sponsor: Novaliq GmbH
Overall Status: Completed

Phase

2/3

Condition

Sjogren's Syndrome

Dry Eyes

Dry Eye Disease

Treatment

N/A

Clinical Study ID

NCT03292809
CYS-003 (ESSENCE)
  • Ages > 18
  • All Genders

Study Summary

The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Signed ICF (Informed Consent Form) and HIPAA (Health Insurance Portability andAccountability Act)
  • 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
  • History of no response to previous topical Cyclosporine A and/or use of topicalCyclosporine 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

Study Design

Total Participants: 328
Study Start date:
October 19, 2017
Estimated Completion Date:
June 20, 2018

Study Description

This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.

Connect with a study center

  • CYS-003 Investigational Site

    Newport Beach, California 92663
    United States

    Site Not Available

  • CYS-003 Investigational Site

    Torrance, California 90505
    United States

    Site Not Available

  • CYS-003 Investigational Site

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • CYS-003 Investigational Site

    Louisville, Kentucky 40206
    United States

    Site Not Available

  • CYS-003 Investigational Site

    Andover, Massachusetts 01810
    United States

    Site Not Available

  • CYS-003 Investigational Site

    Raynham, Massachusetts 02767
    United States

    Site Not Available

  • CYS-003 Investigational Site

    Memphis, Tennessee 38119
    United States

    Site Not Available

  • CYS-003 Investigational Site

    Nashville, Tennessee 37205
    United States

    Site Not Available

  • CYS-003 Investigational Site

    Norfolk, Virginia 23502
    United States

    Site Not Available

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