CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
A Phase 2b/3, Multicenter, Randomized, Double-masked, Vehicle-controlled Clinical Study to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) (ESSENCE Trial)
1 other identifier
interventional
328
1 country
9
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2017
Shorter than P25 for phase_2
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 21, 2017
CompletedFirst Posted
Study publicly available on registry
September 26, 2017
CompletedStudy Start
First participant enrolled
October 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 22, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2018
CompletedResults Posted
Study results publicly available
May 21, 2021
CompletedDecember 22, 2022
December 1, 2022
7 months
September 21, 2017
March 30, 2021
December 21, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Change From Baseline in Total Corneal Fluorescein Staining at Day 29
CFS was assessed in each eye using the National Eye Institute (NEI) scale. A standardized grading system of 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.
baseline and 1 month [day 29]
Change From Baseline in Ocular Surface Disease Index at Day 29
The OSDI score is a composite measure built on 12 questions,with totals ranging from 0 to 100, and higher scores representing a worse disease index.
baseline and 1 month [day 29]
Study Arms (2)
CyclASol Ophthalmic Solution
EXPERIMENTALCylclosporine A solution in vehicle
Vehicle Ophthalmic Solution
PLACEBO COMPARATORVehicle only
Interventions
Cyclosporine A solution in vehicle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novaliq GmbHlead
Study Sites (9)
CYS-003 Investigational Site
Newport Beach, California, 92663, United States
CYS-003 Investigational Site
Torrance, California, 90505, United States
CYS-003 Investigational Site
Indianapolis, Indiana, 46290, United States
CYS-003 Investigational Site
Louisville, Kentucky, 40206, United States
CYS-003 Investigational Site
Andover, Massachusetts, 01810, United States
CYS-003 Investigational Site
Raynham, Massachusetts, 02767, United States
CYS-003 Investigational Site
Memphis, Tennessee, 38119, United States
CYS-003 Investigational Site
Nashville, Tennessee, 37205, United States
CYS-003 Investigational Site
Norfolk, Virginia, 23502, United States
Related Publications (2)
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.
PMID: 34481407RESULTAkpek 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.
PMID: 38334413DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Sonja Kroesser
- Organization
- Novaliq GmbH
Study Officials
- STUDY DIRECTOR
Sonja Kroesser, PhD
Novaliq GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2017
First Posted
September 26, 2017
Study Start
October 19, 2017
Primary Completion
May 22, 2018
Study Completion
June 20, 2018
Last Updated
December 22, 2022
Results First Posted
May 21, 2021
Record last verified: 2022-12
Data Sharing
- IPD Sharing
- Will not share