Phase 2
N=336
Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Dry Eye Disease (DED)
Bottom Line
View on ClinicalTrials.gov: NCT03333057 ↗Enrolled (actual)
336
Serious AEs
1.2%
Results posted
May 2021
Primary outcome: Primary: Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading) — -1.78; -2.11; -0.93 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- NOV03 (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novaliq GmbH
- Primary completion
- May 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Corneal Fluorescein Staining (CFS) Total (National Eye Institute (NEI) Grading) |
-1.78; -2.11; -0.93 | — |
Summary
This study will evaluate the efficacy, safety and tolerability of perfluorohexyloctane (NOV03) at two different dosing regimens compared to saline solution in subjects with Dry Eye Disease (DED).
Eligibility Criteria
Inclusion Criteria
- Signed ICF (Informed Consent Form)
- Subject-reported history of Drye Eye Disease (DED) in both eyes
- Ability and willingness to follow instructions, including participation in all study assessments and visits
Exclusion Criteria
- Women who are pregnant, nursing or planning pregnancy
- Unwillingness to submit a blood 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/peri-ocular malignancy
- History of herpetic keratitis
- Active ocular allergies or ocular allergies that are expected to be active during the study
- Ongoing ocular or systemic infection
- Wear contact lenses within 1 month prior to screening or anticipated use of contact lenses during the study
- Intra-ocular surgery or ocular laser surgery within the previous 6 months, or have 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 saline components
- Use of any topical steroids treatments, topical cyclosporine, lifitegrast, serum tears or topical anti-glaucoma medication within 2 months prior to screening
Data sourced from ClinicalTrials.gov (NCT03333057). 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.