CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004
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
1 other identifier
interventional
202
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2021
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 19, 2020
CompletedFirst Posted
Study publicly available on registry
August 21, 2020
CompletedStudy Start
First participant enrolled
January 4, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2022
CompletedResults Posted
Study results publicly available
October 16, 2023
CompletedOctober 16, 2023
August 1, 2023
1.3 years
August 19, 2020
July 20, 2023
September 19, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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.
12 months
Study Arms (1)
CyclASol Ophthalmic Solution
EXPERIMENTALCyclosporine A solution in vehicle
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novaliq GmbHlead
Study Sites (14)
CYS-005 Investigational Site
Los Angeles, California, 90013, United States
CYS-005 Investigational Site
Newport Beach, California, 92663, United States
CYS-005 Investigational Site
Carmel, Indiana, 46290, United States
CYS-005 Investigational Site
Louisville, Kentucky, 40206, United States
CYS-005 Investigational Site
Andover, Massachusetts, 01810, United States
CYS-005 Investigtional Site
Raynham, Massachusetts, 02767, United States
CYS-005 Investigational Site
Henderson, Nevada, 89052, United States
CYS-005 Investigational Site
Raleigh, North Carolina, 27603, United States
CYS-005 Investigational Site
Shelby, North Carolina, 28150, United States
CYS-005 Investigational Site
Fargo, North Dakota, 58103, United States
CYS-005 Investigational Site
Cranberry Township, Pennsylvania, 16066, United States
CYS-005 Investigational Site
Memphis, Tennessee, 38119, United States
CYS-005 Investigational Site
Layton, Utah, 84041, United States
CYS-005 Investigational Site
Lynchburg, Virginia, 24502, United States
Related Publications (1)
Wirta DL, Galor A, Aune CA, Vollmer PM, Liang E, Meides AS, Krosser S. Long-Term Safety and Efficacy of a Water-Free Cyclosporine 0.1% Ophthalmic Solution for Treatment of Dry Eye Disease: ESSENCE-2 OLE. Cornea. 2024 May 21;44(6):692-700. doi: 10.1097/ICO.0000000000003567.
PMID: 38771801DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Sonja Krösser
- Organization
- Novaliq GmbH
Study Officials
- STUDY DIRECTOR
Sonja Kroesser, PhD
Novaliq GmbH
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 19, 2020
First Posted
August 21, 2020
Study Start
January 4, 2021
Primary Completion
April 30, 2022
Study Completion
May 23, 2022
Last Updated
October 16, 2023
Results First Posted
October 16, 2023
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will not share