Overview

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

Status:
Completed
Trial end date:
2018-06-20
Target enrollment:
0
Participant gender:
All
Summary
The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Novaliq GmbH
Treatments:
Ophthalmic Solutions
Pharmaceutical Solutions
Tetrahydrozoline
Criteria
Inclusion Criteria:

- Signed ICF (Informed Consent Form) and HIPAA (Health Insurance Portability and
Accountability Act)

- 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

Exclusion Criteria:

- 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

- History of no response to previous topical Cyclosporine A and/or 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