Clincosm LogoSign in Get a demo

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

Sponsor
Novaliq GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT04523129
Collaborator
(none)
834
Enrollment
27
Locations
2
Arms
10.1
Actual Duration (Months)
30.9
Patients Per Site
3.1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • Drug: CyclASol topical ocular, eye drops
  • Drug: Vehicle topical ocular, eye drops
 Phase 3

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 Design

Study Type:
Interventional
Actual Enrollment :
834 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Dec 5, 2020
Actual Primary Completion Date :
Sep 3, 2021
Actual Study Completion Date :
Oct 8, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change from baseline in total Corneal Fluorescein Staining [1 month]

      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, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.

    2. Change from Baseline in Eye Dryness Score (VAS) [1 month]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 CYS-004 Investigational Site Phoenix Arizona United States 85032
    2 CYS-004 Investigational Site Los Angeles California United States 90013
    3 CYS-004 Investigational Site Newport Beach California United States 92663
    4 CYS-004 Investigational Site Santa Ana California United States 92705
    5 CYS-004 Investigational Site Colorado Springs Colorado United States 80907
    6 CYS-004 Investigational Site Fort Lauderdale Florida United States 33309
    7 CYS-004 Investigational Site Chicago Illinois United States 60619
    8 CYS-004 Investigational Site Carmel Indiana United States 46290
    9 CYS-004 Investigational Site Indianapolis Indiana United States 46240
    10 CYS-004 Investigational site Louisville Kentucky United States 40206
    11 CYS-004 Investigational Site Andover Massachusetts United States 01810
    12 CYS-004 Investigational Site Raynham Massachusetts United States 02767
    13 CYS-004 Investigational Site Medina Minnesota United States 55364
    14 CYS-004 Investigational Site Kansas City Missouri United States 64111
    15 CYS-004 Investigation Site Kansas City Missouri United States 64154
    16 CYS-004 Investigational Site Henderson Nevada United States 89052
    17 CYS-004 Investigational Site Raleigh North Carolina United States 27603
    18 CYS-004 Investigational Site Shelby North Carolina United States 28150
    19 CYS-004 Investigational Site Fargo North Dakota United States 58103
    20 CYS-004 Investigational Site Cranberry Township Pennsylvania United States 16066
    21 CYS-004 Investigational Site Warwick Rhode Island United States 02886
    22 CYS-004 Investigational Site Memphis Tennessee United States 38119
    23 CYS-004 Investigational Site Smyrna Tennessee United States 37167
    24 CYS-004 Investigational Site Layton Utah United States 84041
    25 CYS-004 Investigational site Ogden Utah United States 84403
    26 CYS-004 Investigational Site Lynchburg Virginia United States 24502
    27 CYS-004 Investigational Site Seattle Washington United States 98119

    Sponsors and Collaborators

    • Novaliq GmbH

    Investigators

    • Study Director: Sonja Kroesser, PhD, Novaliq GmbH

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Novaliq GmbH
    ClinicalTrials.gov Identifier:
    NCT04523129
    Other Study ID Numbers:
    • CYS-004
    First Posted:
    Aug 21, 2020
    Last Update Posted:
    Jan 6, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Dry Eye Syndromes
    Keratoconjunctivitis Sicca
    Eye Diseases
    Ophthalmic Solutions

    Study Results

    No Results Posted as of Jan 6, 2022