ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

A Phase 3, Multi-center, Randomized, Double-masked, Vehicle-controlled Clinical Trial to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Dry Eye Disease

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).

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 3 study will assess the efficacy, safety and tolerability of CyclASol 0.1% Ophthalmic Solution administered bilaterally twice daily versus vehicle.

• Study Type: Interventional
• Enrollment (Actual): 834
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85032
      • CYS-004 Investigational Site
  • California
    • Los Angeles, California, United States, 90013
      • CYS-004 Investigational Site
    • Newport Beach, California, United States, 92663
      • CYS-004 Investigational Site
    • Santa Ana, California, United States, 92705
      • CYS-004 Investigational Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • CYS-004 Investigational Site
  • Florida
    • Fort Lauderdale, Florida, United States, 33309
      • CYS-004 Investigational Site
  • Illinois
    • Chicago, Illinois, United States, 60619
      • CYS-004 Investigational Site
  • Indiana
    • Carmel, Indiana, United States, 46290
      • CYS-004 Investigational Site
    • Indianapolis, Indiana, United States, 46240
      • CYS-004 Investigational Site
  • Kentucky
    • Louisville, Kentucky, United States, 40206
      • CYS-004 Investigational Site
  • Massachusetts
    • Andover, Massachusetts, United States, 01810
      • CYS-004 Investigational Site
    • Raynham, Massachusetts, United States, 02767
      • CYS-004 Investigational Site
  • Minnesota
    • Medina, Minnesota, United States, 55364
      • CYS-004 Investigational Site
  • Missouri
    • Kansas City, Missouri, United States, 64111
      • CYS-004 Investigational Site
    • Kansas City, Missouri, United States, 64154
      • CYS-004 Investigation Site
  • Nevada
    • Henderson, Nevada, United States, 89052
      • CYS-004 Investigational Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27603
      • CYS-004 Investigational Site
    • Shelby, North Carolina, United States, 28150
      • CYS-004 Investigational Site
  • North Dakota
    • Fargo, North Dakota, United States, 58103
      • CYS-004 Investigational Site
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16066
      • CYS-004 Investigational Site
  • Rhode Island
    • Warwick, Rhode Island, United States, 02886
      • CYS-004 Investigational Site
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • CYS-004 Investigational Site
    • Smyrna, Tennessee, United States, 37167
      • CYS-004 Investigational Site
  • Utah
    • Layton, Utah, United States, 84041
      • CYS-004 Investigational Site
    • Ogden, Utah, United States, 84403
      • CYS-004 Investigational Site
  • Virginia
    • Lynchburg, Virginia, United States, 24502
      • CYS-004 Investigational Site
  • Washington
    • Seattle, Washington, United States, 98119
      • CYS-004 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)
• 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
• 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

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; Cyclosporine 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	Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).	baseline and 1 month [day 29]
Change From Baseline in Eye Dryness Score	Eye dryness score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.	baseline and 1 month [day 29]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Total Conjunctival Lissamine Green Staining	Conjunctival staining was assessed by the investigator in the nasal and temporal sections. The Oxford Scheme was used for each section, with a possible score of 0-5 for each section, where 0=absent and 5=severe. The nasal and temporal scores were summed, for a possible score of 0-10 for each eye.	baseline and 1 month [day 29]
Proportion of Responders in Central Corneal Fluorescein Staining Score	≥ 1 score improvement for cCFS on National Eye Institute (NEI) scale: Central Corneal Fluorescein Staining (cCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst).	baseline and 1 month [day 29]
Proportion of Responders in Total Corneal Fluorescein Staining Score	≥ 3 scores improvement for tCFS on National Eye Insititute (NEI) scale: Total Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) -15 (worst).	baseline and 1 month [day 29]
Change From Baseline in Central Corneal Fluorescein Staining	Central Corneal Fluorescein Staining (cCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst).	baseline and 1 month [day 29]
Change From Baseline in Total Corneal Fluorescein Staining	Total Corneal Fluorescein Staining (tCFS) is graded based on the National Eye Institute (NEI) scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining (best), 3 corresponds to maximum staining (worst). The total score is the sum of the 5 subregions ranging from 0 (best) - 15 (worst).	baseline and 2 weeks [day 15]
Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision	Blurred vision score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort.	baseline and 1 month [day 29]

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2020
• Primary Completion (Actual): September 3, 2021
• Study Completion (Actual): October 8, 2021

Study Registration Dates

• First Submitted: August 19, 2020
• First Submitted That Met QC Criteria: August 19, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

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-004

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