Clinical trial NCT03292809: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Official title: A Phase 2b/3, Multicenter, Randomized, Double-masked, Vehicle-controlled Clinical Study to Assess the Efficacy and Safety of Topical CyclASol® for the Treatment of Signs and Symptoms of Dry Eye Disease (DED) (ESSENCE Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Dry Eye Disease
Lead sponsor: Novaliq GmbH
Sponsor class: INDUSTRY
First posted: 2017-09-26
Enrollment: 328
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 study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.

Detailed description: This Phase 2b/3 study will assess the efficacy, safety and and tolerability of CyclASol Ophthalmic Solution as one drop twice daily versus vehicle.

Eligibility criteria: Inclusion Criteria:

* Signed ICF (Informed Consent Form) and HIPAA (Health Insurance Portability and Accountability Act)
* 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
* History of no response to previous topical Cyclosporine A and/or 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

Primary outcomes:
measure: Change From Baseline in Total Corneal Fluorescein Staining at Day 29
timeFrame: baseline and 1 month [day 29]
measure: Change From Baseline in Ocular Surface Disease Index at Day 29
timeFrame: baseline and 1 month [day 29]
Secondary outcomes:
Other outcomes:
Locations:
city: Newport Beach
country: United States
facility: CYS-003 Investigational Site
state: California
city: Torrance
country: United States
facility: CYS-003 Investigational Site
state: California
city: Indianapolis
country: United States
facility: CYS-003 Investigational Site
state: Indiana
city: Louisville
country: United States
facility: CYS-003 Investigational Site
state: Kentucky
city: Andover
country: United States
facility: CYS-003 Investigational Site
state: Massachusetts
city: Raynham
country: United States
facility: CYS-003 Investigational Site
state: Massachusetts
city: Memphis
country: United States
facility: CYS-003 Investigational Site
state: Tennessee
city: Nashville
country: United States
facility: CYS-003 Investigational Site
state: Tennessee
city: Norfolk
country: United States
facility: CYS-003 Investigational Site
state: Virginia
Study officials:
affiliation: Novaliq GmbH
name: Sonja Kroesser, PhD
role: STUDY_DIRECTOR
References:
citation: Sheppard JD, Wirta DL, McLaurin E, Boehmer BE, Ciolino JB, Meides AS, Schluter T, Ousler GW, Usner D, Krosser S. A Water-free 0.1% Cyclosporine A Solution for Treatment of Dry Eye Disease: Results of the Randomized Phase 2B/3 ESSENCE Study. Cornea. 2021 Oct 1;40(10):1290-1297. doi: 10.1097/ICO.0000000000002633.