Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novaliq GmbH
The effect of cyclosporine ophthalmic solution, 0.1% on corneal endothelial cell density (cells/mm²) will be evaluated in comparison to a hypotonic saline solution in subjects with DED after 12 months of treatment.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Be at least 18 years of age;
Provide written informed consent;
Have a subject reported history of dry eye disease (DED) in both eyes
Be able and willing to follow instructions, including participation in all trial assessments and visits.
You may not be if
Be a woman who is pregnant, nursing, or planning a pregnancy;
Unwillingness to to use acceptable means of birth control
Clinically significant slit-lamp findings or abnormal lid anatomy at screening
Ongoing ocular or systemic infection at screening or baseline
Presence of uncontrolled systemic diseases
Presence of known allergy and/or sensitivity to the study drug or its components
Intraocular surgery or ocular laser surgery or significant trauma within 365 days before Visit 1, or have any planned ocular surgeries during the trial period
Have a condition or be in a situation 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.
Randomized in a previous CyclASol trial
Clareo Health | A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
