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