Status:
COMPLETED
Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)
Lead Sponsor:
Novaliq GmbH
Conditions:
Dry Eye Disease (DED)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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
- 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
- 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
Key Trial Info
Start Date :
January 3 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 27 2018
Estimated Enrollment :
336 Patients enrolled
Trial Details
Trial ID
NCT03333057
Start Date
January 3 2018
End Date
July 27 2018
Last Update
January 4 2022
Active Locations (11)
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1
Investigational site
Artesia, California, United States, 90701
2
Investigational Site
Newport Beach, California, United States, 92660
3
Investigational Site
Newport Beach, California, United States, 92663
4
Investigational Site
Santa Ana, California, United States, 92705