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

Phase 3

Completed

Conditions: Dry Eye Disease

Interventions: Drug: CyclASol topical ocular, eye drops
Drug: Vehicle topical ocular, eye drops

Registration Number: NCT04523129

Lead Sponsor: Novaliq GmbH

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 834

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CyclASol Ophthalmic Solution	CyclASol topical ocular, eye drops	Cyclosporine A solution in vehicle
Vehicle Ophthalmic solution	Vehicle topical ocular, eye drops	Vehicle only

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Eye Dryness Score	baseline and 1 month [day 29]	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.
Change From Baseline in Total Corneal Fluorescein Staining	baseline and 1 month [day 29]	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).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Total Conjunctival Lissamine Green Staining	baseline and 1 month [day 29]	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.
Change From Baseline in Central Corneal Fluorescein Staining	baseline and 1 month [day 29]	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).
Proportion of Responders in Central Corneal Fluorescein Staining Score	baseline and 1 month [day 29]	≥ 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	baseline and 1 month [day 29]	≥ 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 Total Corneal Fluorescein Staining	baseline and 2 weeks [day 15]	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	baseline and 1 month [day 29]	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.

Trial Locations

Locations (3): CYS-004 Investigational site
🇺🇸
Ogden, Utah, United States
CYS-004 Investigational Site
🇺🇸
Seattle, Washington, United States
CYS-004 Investigation Site
🇺🇸
Kansas City, Missouri, United States