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

Phase 3

Completed

• Conditions: Dry Eye Disease (DED)
• Interventions: Drug: NOV03

• Registration Number: NCT04140227
• Lead Sponsor: Bausch & Lomb Incorporated

Brief 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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-10-23
• Study First Submitted QC: 2019-10-23
• Study First Posted: 2019-10-25
• Study Start: 2020-09-24
• Status Verified: 2022-01
• Primary Completion: 2022-01-05
• Study Completion: 2022-01-05
• Results First Submitted: 2023-12-11
• Results First Submitted QC: 2023-12-11
• Results First Posted: 2023-12-29
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 256

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NOV03 4 times daily (QID)	NOV03	100% Perfluorohexyloctance solution 4 times daily (QID)

Primary Outcome Measures

Name	Time	Method
Number of Participants With Ocular and Non-ocular Adverse Events	12 months

Trial Locations

Locations (28)

Bausch Site 124; 🇺🇸 Birmingham, Alabama, United States

Bausch Site 125; 🇺🇸 Scottsdale, Arizona, United States

Bausch Site 110; 🇺🇸 Glendale, California, United States

Bausch Site 121; 🇺🇸 Long Beach, California, United States

Bausch Site 102; 🇺🇸 Mission Hills, California, United States

Bausch Site 101; 🇺🇸 Newport Beach, California, United States

Bausch Site 116; 🇺🇸 Rancho Cordova, California, United States

Bausch Site 103; 🇺🇸 Torrance, California, United States

Bausch Site 123; 🇺🇸 Torrance, California, United States

Bausch Site 127; 🇺🇸 Danbury, Connecticut, United States

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