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

NCT04523129 | Completed Phase 3 Results FDA Drug

• 1 other identifier: CYS-004
• Study Type: interventional
• Target: 834
• Locations: 1 country
• Sites: 27

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).

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (6)

• Change From Baseline in Total Conjunctival Lissamine Green Staining

  baseline and 1 month [day 29]

• Proportion of Responders in Central Corneal Fluorescein Staining Score

  baseline and 1 month [day 29]

• Proportion of Responders in Total Corneal Fluorescein Staining Score

  baseline and 1 month [day 29]

• Change From Baseline in Central Corneal Fluorescein Staining

  baseline and 1 month [day 29]

• Change From Baseline in Total Corneal Fluorescein Staining

  baseline and 2 weeks [day 15]

Study Arms (2)

CyclASol Ophthalmic Solution

EXPERIMENTAL

Cyclosporine A solution in vehicle

Drug: CyclASol topical ocular, eye drops

Vehicle Ophthalmic solution

PLACEBO COMPARATOR

Vehicle only

Drug: Vehicle topical ocular, eye drops

Interventions

CyclASol topical ocular, eye drops DRUG

Cyclosporine A solution in vehicle

Also known as: Ciclosporine (CSA)

CyclASol Ophthalmic Solution

Vehicle topical ocular, eye drops DRUG

Vehicle

Also known as: Vehicle

Vehicle Ophthalmic solution

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

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
• 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

Sponsors & Collaborators

• Novaliq GmbH: lead

Study Sites (27)

CYS-004 Investigational Site

Phoenix, Arizona, 85032, United States

Location

CYS-004 Investigational Site

Los Angeles, California, 90013, United States

Location

CYS-004 Investigational Site

Newport Beach, California, 92663, United States

Location

CYS-004 Investigational Site

Santa Ana, California, 92705, United States

Location

CYS-004 Investigational Site

Colorado Springs, Colorado, 80907, United States

Location

CYS-004 Investigational Site

Fort Lauderdale, Florida, 33309, United States

Location

CYS-004 Investigational Site

Chicago, Illinois, 60619, United States

Location

CYS-004 Investigational Site

Carmel, Indiana, 46290, United States

Location

CYS-004 Investigational Site

Indianapolis, Indiana, 46240, United States

Location

CYS-004 Investigational site

Louisville, Kentucky, 40206, United States

Location

CYS-004 Investigational Site

Andover, Massachusetts, 01810, United States

Location

CYS-004 Investigational Site

Raynham, Massachusetts, 02767, United States

Location

CYS-004 Investigational Site

Medina, Minnesota, 55364, United States

Location

CYS-004 Investigational Site

Kansas City, Missouri, 64111, United States

Location

CYS-004 Investigation Site

Kansas City, Missouri, 64154, United States

Location

CYS-004 Investigational Site

Henderson, Nevada, 89052, United States

Location

CYS-004 Investigational Site

Raleigh, North Carolina, 27603, United States

Location

CYS-004 Investigational Site

Shelby, North Carolina, 28150, United States

Location

CYS-004 Investigational Site

Fargo, North Dakota, 58103, United States

Location

CYS-004 Investigational Site

Cranberry Township, Pennsylvania, 16066, United States

Location

CYS-004 Investigational Site

Warwick, Rhode Island, 02886, United States

Location

CYS-004 Investigational Site

Memphis, Tennessee, 38119, United States

Location

CYS-004 Investigational Site

Smyrna, Tennessee, 37167, United States

Location

CYS-004 Investigational Site

Layton, Utah, 84041, United States

Location

CYS-004 Investigational site

Ogden, Utah, 84403, United States

Location

CYS-004 Investigational Site

Lynchburg, Virginia, 24502, United States

Location

CYS-004 Investigational Site

Seattle, Washington, 98119, United States

Location

Related Publications (1)

• Akpek EK, Wirta DL, Downing JE, Tauber J, Sheppard JD, Ciolino JB, Meides AS, Krosser S. Efficacy and Safety of a Water-Free Topical Cyclosporine, 0.1%, Solution for the Treatment of Moderate to Severe Dry Eye Disease: The ESSENCE-2 Randomized Clinical Trial. JAMA Ophthalmol. 2023 May 1;141(5):459-466. doi: 10.1001/jamaophthalmol.2023.0709.

  PMID: 37022717 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Ophthalmic Solutions; Cyclosporins

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Dr. Sonja Kroesser
• Organization: Novaliq GmbH

info@novaliq.com

+49 6221 50259

Study Officials

• Sonja Kroesser, PhD

  Novaliq GmbH

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 19, 2020
• First Posted: August 21, 2020
• Study Start: December 5, 2020
• Primary Completion: September 3, 2021
• Study Completion: October 8, 2021
• Last Updated: March 10, 2023
• Results First Posted: March 10, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (27)