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

NCT04140227 | Completed Phase 3 Results FDA Drug

• 1 other identifier: NVU-004 (Kalahari)
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 28

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.

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Ocular and Non-ocular Adverse Events

  12 months

Study Arms (1)

NOV03 4 times daily (QID)

EXPERIMENTAL

100% Perfluorohexyloctance solution 4 times daily (QID)

Drug: NOV03

Interventions

NOV03 DRUG

100% Perfluorohexyloctane

NOV03 4 times daily (QID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (28)

Bausch Site 124

Birmingham, Alabama, 35233, United States

Location

Bausch Site 125

Scottsdale, Arizona, 85254, United States

Location

Bausch Site 110

Glendale, California, 91204, United States

Location

Bausch Site 121

Long Beach, California, 90805, United States

Location

Bausch Site 102

Mission Hills, California, 91345, United States

Location

Bausch Site 101

Newport Beach, California, 92663, United States

Location

Bausch Site 116

Rancho Cordova, California, 95670, United States

Location

Bausch Site 103

Torrance, California, 90505, United States

Location

Bausch Site 123

Torrance, California, 90505, United States

Location

Bausch Site 127

Danbury, Connecticut, 06810, United States

Location

Bausch Site 129

Fort Myers, Florida, 33901, United States

Location

Bausch Site 115

Jacksonville, Florida, 32256, United States

Location

Bausch Site 106

Largo, Florida, 33773, United States

Location

Bausch Site 117

Tampa, Florida, 33603, United States

Location

Bausch Site 108

Lake Villa, Illinois, 60046, United States

Location

Bausch Site 112

Indianapolis, Indiana, 46260, United States

Location

Bausch Site 119

Edgewood, Kentucky, 41017, United States

Location

Bausch Site 126

Winchester, Massachusetts, 01890, United States

Location

Bausch Site 113

Kansas City, Missouri, 64111, United States

Location

Bausch Site 111

St Louis, Missouri, 63131, United States

Location

Bausch Site 128

Slingerlands, New York, 12159, United States

Location

Bausch Site 114

Raleigh, North Carolina, 27603, United States

Location

Bausch Site 122

Cranberry Township, Pennsylvania, 16066, United States

Location

Bausch Site 107

Memphis, Tennessee, 38119, United States

Location

Bausch Site 109

Nashville, Tennessee, 37205, United States

Location

Bausch Site 120

El Paso, Texas, 79902, United States

Location

Bausch Site 104

Lakeway, Texas, 78738, United States

Location

Bausch Site 118

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

• Protzko EE, Segal BA, Korenfeld MS, Krosser S, Vittitow JL. Long-Term Safety and Efficacy of Perfluorohexyloctane Ophthalmic Solution for the Treatment of Patients With Dry Eye Disease: The KALAHARI Study. Cornea. 2024 Sep 1;43(9):1100-1107. doi: 10.1097/ICO.0000000000003418. Epub 2023 Nov 3.

  PMID: 37921522 DERIVED

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Results Point of Contact

• Title: Johnson Varughese VP Clinical Services
• Organization: Bausch and Lomb

johnson.varughese@bausch.com

908-927-1162

Study Officials

• Johnson Varughese

  Bausch Health

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 25, 2019
• Study Start: September 24, 2020
• Primary Completion: January 5, 2022
• Study Completion: January 5, 2022
• Last Updated: March 4, 2024
• Results First Posted: December 29, 2023

Record last verified: 2022-01

Locations

US (28)