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

• Status: Active, not recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novaliq GmbH
• Treatments: Ophthalmic Solutions

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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