Phase 3
N=202
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease in Subjects Who Completed CYS-004
Dry Eye Disease (DED)
Bottom Line
View on ClinicalTrials.gov: NCT04523142 ↗Enrolled (actual)
202
Serious AEs
2.0%
Results posted
Oct 2023
Primary outcome: Primary: Number of Subjects Reporting Any Adverse Events — 97 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CyclASol Ophthalmic Solution (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novaliq GmbH
- Primary completion
- Apr 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects Reporting Any Adverse Events |
97 | — |
Summary
The objective of this trial is to evaluate safety and tolerability of CyclASol during long-term use in subjects with Dry Eye Disease.
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
Data sourced from ClinicalTrials.gov (NCT04523142). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.