Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)

Launched by BAUSCH & LOMB INCORPORATED · Oct 23, 2019

Keywords

ClinConnect Summary

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.

Gender

ALL

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