Perfluorohexyloctane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

Completed · Phase 2 · Has a placebo group

Conditions studied: Dry Eye Disease (DED)

In brief

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).

Key facts

Study ID

NCT03333057

Run by

Novaliq GmbH

People needed

336

Starts

2018-01-03

Expected to finish

2018-07-27

Last updated by the study team

2022-01-04

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Investigational site — Artesia, California, United States
• Investigational Site — Newport Beach, California, United States
• Investigational Site — Newport Beach, California, United States
• Investigational Site — Santa Ana, California, United States
• Investigational Site — Torrance, California, United States
• Investigational site — Jacksonville, Florida, United States
• Investigational Site — Lake Villa, Illinois, United States
• Investigational Site — Kansas City, Missouri, United States
• Investigational Site — Pennington, New Jersey, United States
• Investigational Site — Nashville, Tennessee, United States
• Investigational Site — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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