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

Novaliq GmbH834 enrolled

Overview

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).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

834

Conditions

Dry Eye Disease

Interventions

CyclASol topical ocular, eye dropsDRUG

Cyclosporine A solution in vehicle

Vehicle topical ocular, eye dropsDRUG

Vehicle

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (27)

Outcomes

Primary Outcomes

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).

Time frame: 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.

Time frame: baseline and 1 month [day 29]

Secondary Outcomes

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.

Time frame: baseline and 1 month [day 29]

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).

Time frame: baseline and 1 month [day 29]

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).

Data from ClinicalTrials.gov

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CYS-004 Investigational Site

Phoenix, Arizona, United States

CYS-004 Investigational Site

Los Angeles, California, United States

CYS-004 Investigational Site

Newport Beach, California, United States

CYS-004 Investigational Site

Santa Ana, California, United States

CYS-004 Investigational Site

Colorado Springs, Colorado, United States

CYS-004 Investigational Site

Fort Lauderdale, Florida, United States

CYS-004 Investigational Site

Chicago, Illinois, United States

CYS-004 Investigational Site

Carmel, Indiana, United States

CYS-004 Investigational Site

Indianapolis, Indiana, United States

CYS-004 Investigational site

Louisville, Kentucky, United States

...and 17 more locations