Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bausch & Lomb Incorporated
The objectives of this trial are to evaluate the safety and tolerability of perfluorohexyloctane (NOV03) ophthalmic solution during long-term use in subjects with Dry Eye Disease (DED) associated with MGD (Meibomian Gland Dysfunction).
Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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
Clareo Health | Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)
