Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novaliq GmbH
This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
