CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
NCT ID: NCT03292809
Last Updated: 2022-12-22
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
328 participants
INTERVENTIONAL
2017-10-19
2018-06-20
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CyclASol Ophthalmic Solution
Cylclosporine A solution in vehicle
CyclASol topical ocular, eye drops
Cyclosporine A solution in vehicle
Vehicle Ophthalmic Solution
Vehicle only
Vehicle topical ocular, eye drops
Vehicle
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CyclASol topical ocular, eye drops
Cyclosporine A solution in vehicle
Vehicle topical ocular, eye drops
Vehicle
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Novaliq GmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sonja Kroesser, PhD
Role: STUDY_DIRECTOR
Novaliq GmbH
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CYS-003 Investigational Site
Newport Beach, California, United States
CYS-003 Investigational Site
Torrance, California, United States
CYS-003 Investigational Site
Indianapolis, Indiana, United States
CYS-003 Investigational Site
Louisville, Kentucky, United States
CYS-003 Investigational Site
Andover, Massachusetts, United States
CYS-003 Investigational Site
Raynham, Massachusetts, United States
CYS-003 Investigational Site
Memphis, Tennessee, United States
CYS-003 Investigational Site
Nashville, Tennessee, United States
CYS-003 Investigational Site
Norfolk, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Sheppard JD, Wirta DL, McLaurin E, Boehmer BE, Ciolino JB, Meides AS, Schluter T, Ousler GW, Usner D, Krosser S. A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study. Cornea. 2021 Oct 1;40(10):1290-1297. doi: 10.1097/ICO.0000000000002633.
Akpek EK, Sheppard JD, Hamm A, Angstmann-Mehr S, Krosser S. Efficacy of a new water-free topical cyclosporine 0.1% solution for optimizing the ocular surface in patients with dry eye and cataract. J Cataract Refract Surg. 2024 Jun 1;50(6):644-650. doi: 10.1097/j.jcrs.0000000000001423.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Related Links
Access external resources that provide additional context or updates about the study.
Publication of Study Results
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CYS-003 (ESSENCE)
Identifier Type: -
Identifier Source: org_study_id