Phase 3
N=328
CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT03292809 ↗Enrolled (actual)
328
Serious AEs
0.9%
Results posted
May 2021
Primary outcome: Primary: Change From Baseline in Total Corneal Fluorescein Staining at Day 29 — -2.9; -2.2 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- CyclASol topical ocular, eye drops (Drug); Vehicle topical ocular, eye drops (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novaliq GmbH
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Total Corneal Fluorescein Staining at Day 29 |
-2.9; -2.2 | — |
| PRIMARY Change From Baseline in Ocular Surface Disease Index at Day 29 |
-7.08; -5.37 | — |
Summary
The objective of this study is to assess the efficacy, safety, and tolerability of CyclASol Ophthalmic Solution in comparison to vehicle for the treatment of the signs and symptoms of DED.
Eligibility Criteria
Inclusion Criteria
- Signed ICF (Informed Consent Form) and HIPAA (Health Insurance Portability and Accountability Act)
- Patient-reported history of DED in both eyes
- Current use of OTC (over-the-counter) and/or artificial tears for dry eye symptoms
- Ability and willingness to follow instructions, including participation in all study assessments and visits
Exclusion Criteria
- Women who are pregnant, nursing or planning a pregnancy
- Unwillingness to submit a urine pregnancy test at screening and the last visit (or early termination visit) if of childbearing potential, or unwillingness to use acceptable means of birth control
- Clinically significant slit-lamp findings or abnormal lid anatomy at screening
- Ocular/periocular malignancy
- History of herpetic keratitis
- Active ocular allergies or ocular allergies that may become active during the study period
- Ongoing ocular or systemic infection at screening or baseline
- Wear of contact lenses within 3 months prior to screening or anticipated use of contact lenses during the study
- History of no response to previous topical Cyclosporine A and/or use of topical Cyclosporine A or Liftigrast within 2 months prior to screening
- Intraocular surgery or ocular laser surgery within the previous 6 months, or have any planned ocular and/or lid surgeries over the study period
- Presence of uncontrolled systemic diseases
- Presence of known allergy and/or sensitivity to the study drug or its components
Data sourced from ClinicalTrials.gov (NCT03292809). 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.