Overview

Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)

Status:
Completed
Trial end date:
2021-03-12
Target enrollment:
0
Participant gender:
All
Summary
This trial will evaluate the efficacy, safety, and tolerability of NOV03 ophthalmic solution in comparison to a saline control for the treatment of the signs and symptoms of Dry Eye Disease (DED) associated with Meibomian Gland Dysfunction (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 and
Visit 1

- 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