Status:
COMPLETED
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Lead Sponsor:
Novaliq GmbH
Conditions:
Dry Eye Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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.
Detailed Description
This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 19 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2018
Estimated Enrollment :
328 Patients enrolled
Trial Details
Trial ID
NCT03292809
Start Date
October 19 2017
End Date
June 20 2018
Last Update
December 22 2022
Active Locations (9)
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1
CYS-003 Investigational Site
Newport Beach, California, United States, 92663
2
CYS-003 Investigational Site
Torrance, California, United States, 90505
3
CYS-003 Investigational Site
Indianapolis, Indiana, United States, 46290
4
CYS-003 Investigational Site
Louisville, Kentucky, United States, 40206