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

Dry Eye Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292809
• Other study ID #: CYS-003 (ESSENCE)
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: October 19, 2017
• Est. completion date: June 20, 2018

Study information

• Verified date: December 2022
• Source: Novaliq GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 328
• Est. completion date: June 20, 2018
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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-003 Investigational Site	Andover	Massachusetts
United States	CYS-003 Investigational Site	Indianapolis	Indiana
United States	CYS-003 Investigational Site	Louisville	Kentucky
United States	CYS-003 Investigational Site	Memphis	Tennessee
United States	CYS-003 Investigational Site	Nashville	Tennessee
United States	CYS-003 Investigational Site	Newport Beach	California
United States	CYS-003 Investigational Site	Norfolk	Virginia
United States	CYS-003 Investigational Site	Raynham	Massachusetts
United States	CYS-003 Investigational Site	Torrance	California

Sponsors (1)

Lead Sponsor	Collaborator
Novaliq GmbH

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 O — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Corneal Fluorescein Staining at Day 29	CFS was assessed in each eye using the National Eye Institute (NEI) scale.; A standardized grading system of 0-3 is used for each of the five areas on each cornea. Grade 0 will be specified when no staining is present. The maximum total score for each eye is 15. Higher values describe greater staining and corneal damage.	baseline and 1 month [day 29]
Primary	Change From Baseline in Ocular Surface Disease Index at Day 29	The OSDI score is a composite measure built on 12 questions,with totals ranging from 0 to 100, and higher scores representing a worse disease index.	baseline and 1 month [day 29]

External Links

•   Publication of Study Results