Status:
COMPLETED
ESSENCE 2: 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:
PHASE3
Brief Summary
The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).
Detailed Description
This Phase 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.
Eligibility Criteria
Inclusion
- 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
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
- 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
Key Trial Info
Start Date :
December 5 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 8 2021
Estimated Enrollment :
834 Patients enrolled
Trial Details
Trial ID
NCT04523129
Start Date
December 5 2020
End Date
October 8 2021
Last Update
March 10 2023
Active Locations (27)
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1
CYS-004 Investigational Site
Phoenix, Arizona, United States, 85032
2
CYS-004 Investigational Site
Los Angeles, California, United States, 90013
3
CYS-004 Investigational Site
Newport Beach, California, United States, 92663
4
CYS-004 Investigational Site
Santa Ana, California, United States, 92705