Clinical trial NCT04523129: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2020-08-21
Enrollment: 834
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change From Baseline in Total Corneal Fluorescein Staining
timeFrame: baseline and 1 month [day 29]
measure: Change From Baseline in Eye Dryness Score
timeFrame: baseline and 1 month [day 29]
Secondary outcomes:
measure: Change From Baseline in Total Conjunctival Lissamine Green Staining
timeFrame: baseline and 1 month [day 29]
measure: Proportion of Responders in Central Corneal Fluorescein Staining Score
timeFrame: baseline and 1 month [day 29]
measure: Proportion of Responders in Total Corneal Fluorescein Staining Score
timeFrame: baseline and 1 month [day 29]
measure: Change From Baseline in Central Corneal Fluorescein Staining
timeFrame: baseline and 1 month [day 29]
measure: Change From Baseline in Total Corneal Fluorescein Staining
timeFrame: baseline and 2 weeks [day 15]
measure: Change From Baseline in Visual Analogue Scale (VAS) for Blurred Vision
timeFrame: baseline and 1 month [day 29]
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: CYS-004 Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: CYS-004 Investigational Site
state: California
city: Newport Beach
country: United States
facility: CYS-004 Investigational Site
state: California
city: Santa Ana
country: United States
facility: CYS-004 Investigational Site
state: California
city: Colorado Springs
country: United States
facility: CYS-004 Investigational Site
state: Colorado
city: Fort Lauderdale
country: United States
facility: CYS-004 Investigational Site
state: Florida
city: Chicago
country: United States
facility: CYS-004 Investigational Site
state: Illinois
city: Carmel
country: United States
facility: CYS-004 Investigational Site
state: Indiana
city: Indianapolis
country: United States
facility: CYS-004 Investigational Site
state: Indiana
city: Louisville
country: United States
facility: CYS-004 Investigational site
state: Kentucky
city: Andover
country: United States
facility: CYS-004 Investigational Site
state: Massachusetts
city: Raynham
country: United States
facility: CYS-004 Investigational Site
state: Massachusetts
city: Medina
country: United States
facility: CYS-004 Investigational Site
state: Minnesota
city: Kansas City
country: United States
facility: CYS-004 Investigational Site
state: Missouri
city: Kansas City
country: United States
facility: CYS-004 Investigation Site
state: Missouri
city: Henderson
country: United States
facility: CYS-004 Investigational Site
state: Nevada
city: Raleigh
country: United States
facility: CYS-004 Investigational Site
state: North Carolina
city: Shelby
country: United States
facility: CYS-004 Investigational Site
state: North Carolina
city: Fargo
country: United States
facility: CYS-004 Investigational Site
state: North Dakota
city: Cranberry Township
country: United States
facility: CYS-004 Investigational Site
state: Pennsylvania
city: Warwick
country: United States
facility: CYS-004 Investigational Site
state: Rhode Island
city: Memphis
country: United States
facility: CYS-004 Investigational Site
state: Tennessee
city: Smyrna
country: United States
facility: CYS-004 Investigational Site
state: Tennessee
city: Layton
country: United States
facility: CYS-004 Investigational Site
state: Utah
city: Ogden
country: United States
facility: CYS-004 Investigational site
state: Utah
city: Lynchburg
country: United States
facility: CYS-004 Investigational Site
state: Virginia
city: Seattle
country: United States
facility: CYS-004 Investigational Site
state: Washington
Study officials:
affiliation: Novaliq GmbH
name: Sonja Kroesser, PhD
role: STUDY_DIRECTOR
References: