Dry Eye Disease (DED) Clinical Trial
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
Verified date | August 2023 |
Source | Novaliq GmbH |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.
Status | Completed |
Enrollment | 202 |
Est. completion date | May 23, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | CYS-005 Investigational Site | Andover | Massachusetts |
United States | CYS-005 Investigational Site | Carmel | Indiana |
United States | CYS-005 Investigational Site | Cranberry Township | Pennsylvania |
United States | CYS-005 Investigational Site | Fargo | North Dakota |
United States | CYS-005 Investigational Site | Henderson | Nevada |
United States | CYS-005 Investigational Site | Layton | Utah |
United States | CYS-005 Investigational Site | Los Angeles | California |
United States | CYS-005 Investigational Site | Louisville | Kentucky |
United States | CYS-005 Investigational Site | Lynchburg | Virginia |
United States | CYS-005 Investigational Site | Memphis | Tennessee |
United States | CYS-005 Investigational Site | Newport Beach | California |
United States | CYS-005 Investigational Site | Raleigh | North Carolina |
United States | CYS-005 Investigtional Site | Raynham | Massachusetts |
United States | CYS-005 Investigational Site | Shelby | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Novaliq GmbH |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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