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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CyclASol topical ocular, eye drops
Vehicle topical ocular, eye drops
Sponsored by
Novaliq GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigation Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site
  • CYS-004 Investigational site
  • CYS-004 Investigational Site
  • CYS-004 Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CyclASol Ophthalmic Solution

Vehicle Ophthalmic solution

Arm Description

Cyclosporine A solution in vehicle

Vehicle only

Outcomes

Primary Outcome Measures

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).
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.

Secondary Outcome Measures

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.
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).
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).
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).
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).
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.

Full Information

First Posted
August 19, 2020
Last Updated
March 9, 2023
Sponsor
Novaliq GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04523129
Brief Title
ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 5, 2020 (Actual)
Primary Completion Date
September 3, 2021 (Actual)
Study Completion Date
October 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novaliq GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
834 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CyclASol Ophthalmic Solution
Arm Type
Experimental
Arm Description
Cyclosporine A solution in vehicle
Arm Title
Vehicle Ophthalmic solution
Arm Type
Placebo Comparator
Arm Description
Vehicle only
Intervention Type
Drug
Intervention Name(s)
CyclASol topical ocular, eye drops
Other Intervention Name(s)
Ciclosporine (CSA)
Intervention Description
Cyclosporine A solution in vehicle
Intervention Type
Drug
Intervention Name(s)
Vehicle topical ocular, eye drops
Other Intervention Name(s)
Vehicle
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
Change From Baseline in Total Corneal Fluorescein Staining
Description
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).
Time Frame
baseline and 1 month [day 29]
Title
Change From Baseline in Eye Dryness Score
Description
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.
Time Frame
baseline and 1 month [day 29]
Secondary Outcome Measure Information:
Title
Change From Baseline in Total Conjunctival Lissamine Green Staining
Description
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.
Time Frame
baseline and 1 month [day 29]
Title
Proportion of Responders in Central Corneal Fluorescein Staining Score
Description
≥ 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).
Time Frame
baseline and 1 month [day 29]
Title
Proportion of Responders in Total Corneal Fluorescein Staining Score
Description
≥ 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).
Time Frame
baseline and 1 month [day 29]
Title
Change From Baseline in Central Corneal Fluorescein Staining
Description
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).
Time Frame
baseline and 1 month [day 29]
Title
Change From Baseline in Total Corneal Fluorescein Staining
Description
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).
Time Frame
baseline and 2 weeks [day 15]
Title
Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision
Description
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.
Time Frame
baseline and 1 month [day 29]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja Kroesser, PhD
Organizational Affiliation
Novaliq GmbH
Official's Role
Study Director
Facility Information:
Facility Name
CYS-004 Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85032
Country
United States
Facility Name
CYS-004 Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
CYS-004 Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
CYS-004 Investigational Site
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
CYS-004 Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
CYS-004 Investigational Site
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33309
Country
United States
Facility Name
CYS-004 Investigational Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60619
Country
United States
Facility Name
CYS-004 Investigational Site
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
CYS-004 Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46240
Country
United States
Facility Name
CYS-004 Investigational site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
CYS-004 Investigational Site
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
CYS-004 Investigational Site
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
CYS-004 Investigational Site
City
Medina
State/Province
Minnesota
ZIP/Postal Code
55364
Country
United States
Facility Name
CYS-004 Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
CYS-004 Investigation Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
CYS-004 Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
CYS-004 Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
CYS-004 Investigational Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
CYS-004 Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
CYS-004 Investigational Site
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
CYS-004 Investigational Site
City
Warwick
State/Province
Rhode Island
ZIP/Postal Code
02886
Country
United States
Facility Name
CYS-004 Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
CYS-004 Investigational Site
City
Smyrna
State/Province
Tennessee
ZIP/Postal Code
37167
Country
United States
Facility Name
CYS-004 Investigational Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
CYS-004 Investigational site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
CYS-004 Investigational Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
CYS-004 Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98119
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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