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

Primary Purpose

Dry Eye Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CyclASol topical ocular, eye drops
Vehicle topical ocular, eye drops
Sponsored by
Novaliq GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CYS-003 Investigational Site
  • CYS-003 Investigational Site
  • CYS-003 Investigational Site
  • CYS-003 Investigational Site
  • CYS-003 Investigational Site
  • CYS-003 Investigational Site
  • CYS-003 Investigational Site
  • CYS-003 Investigational Site
  • CYS-003 Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CyclASol Ophthalmic Solution

Vehicle Ophthalmic Solution

Arm Description

Cylclosporine A solution in vehicle

Vehicle only

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
September 21, 2017
Last Updated
December 21, 2022
Sponsor
Novaliq GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT03292809
Brief Title
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

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
October 19, 2017 (Actual)
Primary Completion Date
May 22, 2018 (Actual)
Study Completion Date
June 20, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novaliq GmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
328 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CyclASol Ophthalmic Solution
Arm Type
Experimental
Arm Description
Cylclosporine A solution in vehicle
Arm Title
Vehicle Ophthalmic Solution
Arm Type
Placebo Comparator
Arm Description
Vehicle only
Intervention Type
Drug
Intervention Name(s)
CyclASol topical ocular, eye drops
Other Intervention Name(s)
Ciclosporine (CsA)
Intervention Description
Cyclosporine A solution in vehicle
Intervention Type
Drug
Intervention Name(s)
Vehicle topical ocular, eye drops
Other Intervention Name(s)
Vehicle
Intervention Description
Vehicle
Primary Outcome Measure Information:
Title
Change From Baseline in Total Corneal Fluorescein Staining at Day 29
Description
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.
Time Frame
baseline and 1 month [day 29]
Title
Change From Baseline in Ocular Surface Disease Index at Day 29
Description
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.
Time Frame
baseline and 1 month [day 29]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sonja Kroesser, PhD
Organizational Affiliation
Novaliq GmbH
Official's Role
Study Director
Facility Information:
Facility Name
CYS-003 Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
CYS-003 Investigational Site
City
Torrance
State/Province
California
ZIP/Postal Code
90505
Country
United States
Facility Name
CYS-003 Investigational Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
CYS-003 Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
CYS-003 Investigational Site
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
CYS-003 Investigational Site
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
CYS-003 Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
CYS-003 Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
CYS-003 Investigational Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34481407
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.
Results Reference
result
Links:
URL
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8423142/
Description
Publication of Study Results

Learn more about this trial

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

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