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)

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.

Study Overview

• Status: Completed
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: CyclASol topical ocular, eye drops; Drug: Vehicle topical ocular, eye drops

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.

• Study Type: Interventional
• Enrollment (Actual): 328
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Newport Beach, California, United States, 92663
      • CYS-003 Investigational Site
    • Torrance, California, United States, 90505
      • CYS-003 Investigational Site
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • CYS-003 Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • CYS-003 Investigational Site
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • CYS-003 Investigational Site
    • Raynham, Massachusetts, United States, 02767
      • CYS-003 Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • CYS-003 Investigational Site
    • Nashville, Tennessee, United States, 37205
      • CYS-003 Investigational Site
  • Virginia
    • Norfolk, Virginia, United States, 23502
      • CYS-003 Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CyclASol Ophthalmic Solution; Cylclosporine A solution in vehicle	Drug: CyclASol topical ocular, eye drops; Cyclosporine A solution in vehicle; Other Names: Ciclosporine (CsA)
Placebo Comparator: Vehicle Ophthalmic Solution; Vehicle only	Drug: Vehicle topical ocular, eye drops; Vehicle; Other Names: Vehicle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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]

Collaborators and Investigators

• Sponsor: Novaliq GmbH
• Investigators: Study Director: Sonja Kroesser, PhD, Novaliq GmbH

Publications and helpful links

General Publications

• 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.

Helpful Links

• Publication of Study Results

Study record dates

Study Major Dates

• Study Start (Actual): October 19, 2017
• Primary Completion (Actual): May 22, 2018
• Study Completion (Actual): June 20, 2018

Study Registration Dates

• First Submitted: September 21, 2017
• First Submitted That Met QC Criteria: September 21, 2017
• First Posted (Actual): September 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 22, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca; Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: CYS-003 (ESSENCE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No