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

Completed · Phase 3

Conditions studied: Dry Eye Disease

In brief

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).

Key facts

Study ID

NCT04523129

Run by

Novaliq GmbH

People needed

834

Starts

2020-12-05

Expected to finish

2021-10-08

Last updated by the study team

2023-03-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 study assessments and visits

You may not qualify if…

• Women who are pregnant, nursing or planning a pregnancy
• Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable 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 study period
• Ongoing ocular or systemic infection at screening or baseline
• Wear of contact lenses within 3 months prior to screening or anticipated use of contact 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 any planned 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

Where it is running

• CYS-004 Investigational Site — Phoenix, Arizona, United States
• CYS-004 Investigational Site — Los Angeles, California, United States
• CYS-004 Investigational Site — Newport Beach, California, United States
• CYS-004 Investigational Site — Santa Ana, California, United States
• CYS-004 Investigational Site — Colorado Springs, Colorado, United States
• CYS-004 Investigational Site — Fort Lauderdale, Florida, United States
• CYS-004 Investigational Site — Chicago, Illinois, United States
• CYS-004 Investigational Site — Carmel, Indiana, United States
• CYS-004 Investigational Site — Indianapolis, Indiana, United States
• CYS-004 Investigational site — Louisville, Kentucky, United States
• CYS-004 Investigational Site — Andover, Massachusetts, United States
• CYS-004 Investigational Site — Raynham, Massachusetts, United States
• CYS-004 Investigational Site — Medina, Minnesota, United States
• CYS-004 Investigational Site — Kansas City, Missouri, United States
• CYS-004 Investigation Site — Kansas City, Missouri, United States
• CYS-004 Investigational Site — Henderson, Nevada, United States
• CYS-004 Investigational Site — Raleigh, North Carolina, United States
• CYS-004 Investigational Site — Shelby, North Carolina, United States
• CYS-004 Investigational Site — Fargo, North Dakota, United States
• CYS-004 Investigational Site — Cranberry Township, Pennsylvania, United States
• CYS-004 Investigational Site — Warwick, Rhode Island, United States
• CYS-004 Investigational Site — Memphis, Tennessee, United States
• CYS-004 Investigational Site — Smyrna, Tennessee, United States
• CYS-004 Investigational Site — Layton, Utah, United States
• CYS-004 Investigational site — Ogden, Utah, United States

Full record on ClinicalTrials.gov

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