CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004

Completed · Phase 3

Conditions studied: Dry Eye Disease (DED)

In brief

The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.

Key facts

Study ID

NCT04523142

Run by

Novaliq GmbH

People needed

202

Starts

2021-01-04

Expected to finish

2022-05-23

Last updated by the study team

2023-10-16

Who can join

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

You may qualify if…

• Have completed the clinical trial CYS-004 and habe been compliant with trial procedures
• Signed ICF (Informed Consent Form)
• Subject-reported history of DED in both eyes
• Ability and willingness to follow instructions, including participation in all study assessments and visits

You may not qualify if…

• Early termination of CYS-004
• Clinically significant slit-lamp findings or ocular conditions that require prescriptive medical treatment and/or in the opinion of the investigator may interfere with trial parameters
• Have a history of herpetic keratitis;
• Have an ocular or periocular malignancy;
• Be unwilling to avoid wearing contact lenses during the trial;
• Have any planned ocular or eyelid surgeries during the trial period
• Be a woman who is pregnant, nursing or planning a pregnancy
• Unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing potential
• Women of childbearing potential not using an acceptable means of contraception
• Presence of known allergy and/or sensitivity to the study drug or its components
• Be currently using an investigational drug or device or have used an investigational drug or device within 60 days before Visit 1 other than for CYS-004
• Have a condition or be in a situation (eg language barrier) which the investigator feels may put the subject at significant risk,may confound the trial results, or may interfere with the subject's participation in the trial significantly

Where it is running

• CYS-005 Investigational Site — Los Angeles, California, United States
• CYS-005 Investigational Site — Newport Beach, California, United States
• CYS-005 Investigational Site — Carmel, Indiana, United States
• CYS-005 Investigational Site — Louisville, Kentucky, United States
• CYS-005 Investigational Site — Andover, Massachusetts, United States
• CYS-005 Investigtional Site — Raynham, Massachusetts, United States
• CYS-005 Investigational Site — Henderson, Nevada, United States
• CYS-005 Investigational Site — Raleigh, North Carolina, United States
• CYS-005 Investigational Site — Shelby, North Carolina, United States
• CYS-005 Investigational Site — Fargo, North Dakota, United States
• CYS-005 Investigational Site — Cranberry Township, Pennsylvania, United States
• CYS-005 Investigational Site — Memphis, Tennessee, United States
• CYS-005 Investigational Site — Layton, Utah, United States
• CYS-005 Investigational Site — Lynchburg, Virginia, United States

Full record on ClinicalTrials.gov

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