Overview

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

Status:
Recruiting
Trial end date:
2021-12-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bausch & Lomb Incorporated
Novaliq GmbH
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