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

Dry Eye Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04523129
• Other study ID #: CYS-004
• Status: Completed
• Phase: Phase 3
• Start date: December 5, 2020
• Est. completion date: October 8, 2021

Study information

• Verified date: March 2023
• Source: Novaliq GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 834
• Est. completion date: October 8, 2021
• Est. primary completion date: September 3, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease
• Dry Eye Syndromes
• Eye Diseases
• Keratoconjunctivitis Sicca

Intervention

Drug:
• CyclASol topical ocular, eye drops
Cyclosporine A solution in vehicle
• Vehicle topical ocular, eye drops
Vehicle

Locations

Country	Name	City	State
United States	CYS-004 Investigational Site	Andover	Massachusetts
United States	CYS-004 Investigational Site	Carmel	Indiana
United States	CYS-004 Investigational Site	Chicago	Illinois
United States	CYS-004 Investigational Site	Colorado Springs	Colorado
United States	CYS-004 Investigational Site	Cranberry Township	Pennsylvania
United States	CYS-004 Investigational Site	Fargo	North Dakota
United States	CYS-004 Investigational Site	Fort Lauderdale	Florida
United States	CYS-004 Investigational Site	Henderson	Nevada
United States	CYS-004 Investigational Site	Indianapolis	Indiana
United States	CYS-004 Investigation Site	Kansas City	Missouri
United States	CYS-004 Investigational Site	Kansas City	Missouri
United States	CYS-004 Investigational Site	Layton	Utah
United States	CYS-004 Investigational Site	Los Angeles	California
United States	CYS-004 Investigational site	Louisville	Kentucky
United States	CYS-004 Investigational Site	Lynchburg	Virginia
United States	CYS-004 Investigational Site	Medina	Minnesota
United States	CYS-004 Investigational Site	Memphis	Tennessee
United States	CYS-004 Investigational Site	Newport Beach	California
United States	CYS-004 Investigational site	Ogden	Utah
United States	CYS-004 Investigational Site	Phoenix	Arizona
United States	CYS-004 Investigational Site	Raleigh	North Carolina
United States	CYS-004 Investigational Site	Raynham	Massachusetts
United States	CYS-004 Investigational Site	Santa Ana	California
United States	CYS-004 Investigational Site	Seattle	Washington
United States	CYS-004 Investigational Site	Shelby	North Carolina
United States	CYS-004 Investigational Site	Smyrna	Tennessee
United States	CYS-004 Investigational Site	Warwick	Rhode Island

Sponsors (1)

Lead Sponsor	Collaborator
Novaliq GmbH

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	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	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]
Secondary	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]