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CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004

Primary Purpose

Dry Eye Disease (DED)

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CyclASol Ophthalmic Solution
Sponsored by
Novaliq GmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dry Eye Disease (DED)

Eligibility Criteria

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

Inclusion Criteria:

  • Have completed the clinical trial CYS-004 and habe been compliant with trial procedures
  • Signed ICF (Informed Consent Form)
  • Subject-reported history of DED in both eyes
  • Ability and willingness to follow instructions, including participation in all study assessments and visits

Exclusion Criteria:

  • Early termination of CYS-004
  • Clinically significant slit-lamp findings or ocular conditions that require prescriptive medical treatment and/or in the opinion of the investigator may interfere with trial parameters
  • Have a history of herpetic keratitis;
  • Have an ocular or periocular malignancy;
  • Be unwilling to avoid wearing contact lenses during the trial;
  • Have any planned ocular or eyelid surgeries during the trial period
  • Be a woman who is pregnant, nursing or planning a pregnancy
  • Unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing potential
  • Women of childbearing potential not using an acceptable means of contraception
  • Presence of known allergy and/or sensitivity to the study drug or its components
  • Be currently using an investigational drug or device or have used an investigational drug or device within 60 days before Visit 1 other than for CYS-004
  • Have a condition or be in a situation (eg language barrier) which the investigator feels may put the subject at significant risk,may confound the trial results, or may interfere with the subject's participation in the trial significantly

Sites / Locations

  • CYS-005 Investigational Site
  • CYS-005 Investigational Site
  • CYS-005 Investigational Site
  • CYS-005 Investigational Site
  • CYS-005 Investigational Site
  • CYS-005 Investigtional Site
  • CYS-005 Investigational Site
  • CYS-005 Investigational Site
  • CYS-005 Investigational Site
  • CYS-005 Investigational Site
  • CYS-005 Investigational Site
  • CYS-005 Investigational Site
  • CYS-005 Investigational Site
  • CYS-005 Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CyclASol Ophthalmic Solution

Arm Description

Cyclosporine A solution in vehicle

Outcomes

Primary Outcome Measures

Number of Subjects Reporting Any Adverse Events
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related. 200 participants from the safety set were analyzed.

Secondary Outcome Measures

Full Information

First Posted
August 19, 2020
Last Updated
September 19, 2023
Sponsor
Novaliq GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04523142
Brief Title
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004
Official Title
A Phase 3, Multi-center, Open-label, Single-arm Clinical Trial to Assess the Long-term Safety and Tolerability of Topical CyclASol® for the Treatment of Dry Eye Disease in Subjects Who Completed the Clinical Trial CYS-004
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 4, 2021 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
May 23, 2022 (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

5. Study Description

Brief Summary
The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.
Detailed Description
Phase 3 multicenter, open-label, single-arm clinical trial to evaluate the safety, tolerability and efficacy of CyclASol in subjects with signs and symptoms of Dry Eye Disease. Subjects who completed the trial CYS-004, had a subject-reported history of dry eye in both eyes and met all other study eligibility criteria were dosed CyclASol bilaterally BID for 12 months.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
202 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CyclASol Ophthalmic Solution
Arm Type
Experimental
Arm Description
Cyclosporine A solution in vehicle
Intervention Type
Drug
Intervention Name(s)
CyclASol Ophthalmic Solution
Intervention Description
Cyclosporine A solution in vehicle
Primary Outcome Measure Information:
Title
Number of Subjects Reporting Any Adverse Events
Description
An adverse event was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not the event was considered drug related. 200 participants from the safety set were analyzed.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Have completed the clinical trial CYS-004 and habe been compliant with trial procedures Signed ICF (Informed Consent Form) Subject-reported history of DED in both eyes Ability and willingness to follow instructions, including participation in all study assessments and visits Exclusion Criteria: Early termination of CYS-004 Clinically significant slit-lamp findings or ocular conditions that require prescriptive medical treatment and/or in the opinion of the investigator may interfere with trial parameters Have a history of herpetic keratitis; Have an ocular or periocular malignancy; Be unwilling to avoid wearing contact lenses during the trial; Have any planned ocular or eyelid surgeries during the trial period Be a woman who is pregnant, nursing or planning a pregnancy Unwillingness to submit a urine pregnancy test at all onsite visits if of childbearing potential Women of childbearing potential not using an acceptable means of contraception Presence of known allergy and/or sensitivity to the study drug or its components Be currently using an investigational drug or device or have used an investigational drug or device within 60 days before Visit 1 other than for CYS-004 Have a condition or be in a situation (eg language barrier) which the investigator feels may put the subject at significant risk,may confound the trial results, or may interfere with the subject's participation in the trial significantly
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-005 Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90013
Country
United States
Facility Name
CYS-005 Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
CYS-005 Investigational Site
City
Carmel
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
CYS-005 Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40206
Country
United States
Facility Name
CYS-005 Investigational Site
City
Andover
State/Province
Massachusetts
ZIP/Postal Code
01810
Country
United States
Facility Name
CYS-005 Investigtional Site
City
Raynham
State/Province
Massachusetts
ZIP/Postal Code
02767
Country
United States
Facility Name
CYS-005 Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
CYS-005 Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27603
Country
United States
Facility Name
CYS-005 Investigational Site
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
CYS-005 Investigational Site
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
CYS-005 Investigational Site
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
CYS-005 Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38119
Country
United States
Facility Name
CYS-005 Investigational Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
CYS-005 Investigational Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004

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