Status:
COMPLETED
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004
Lead Sponsor:
Novaliq GmbH
Conditions:
Dry Eye Disease (DED)
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 4 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 23 2022
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT04523142
Start Date
January 4 2021
End Date
May 23 2022
Last Update
October 16 2023
Active Locations (14)
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1
CYS-005 Investigational Site
Los Angeles, California, United States, 90013
2
CYS-005 Investigational Site
Newport Beach, California, United States, 92663
3
CYS-005 Investigational Site
Carmel, Indiana, United States, 46290
4
CYS-005 Investigational Site
Louisville, Kentucky, United States, 40206