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

Dry Eye Disease (DED) Clinical Trial

Official title:

A Phase 3, Multi-Center, Open-Label, Single-Arm Extension Clinical Trial to Assess the Extended Long-Term Safety and Tolerability of NOV03 (Perfluorohexyloctane) in Subjects Who Completed Trial NVU-003 (Kalahari Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04140227
• Other study ID #: NVU-004 (Kalahari)
• Status: Completed
• Phase: Phase 3
• Start date: September 24, 2020
• Est. completion date: January 5, 2022

Study information

• Verified date: January 2022
• Source: Bausch & Lomb Incorporated
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 256
• Est. completion date: January 5, 2022
• Est. primary completion date: January 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye Disease (DED)
• Dry Eye Syndromes
• Eye Diseases

Intervention

Drug:
• NOV03
100% Perfluorohexyloctane

Locations

Country	Name	City	State
United States	Bausch Site 124	Birmingham	Alabama
United States	Bausch Site 122	Cranberry Township	Pennsylvania
United States	Bausch Site 127	Danbury	Connecticut
United States	Bausch Site 119	Edgewood	Kentucky
United States	Bausch Site 120	El Paso	Texas
United States	Bausch Site 129	Fort Myers	Florida
United States	Bausch Site 110	Glendale	California
United States	Bausch Site 112	Indianapolis	Indiana
United States	Bausch Site 115	Jacksonville	Florida
United States	Bausch Site 113	Kansas City	Missouri
United States	Bausch Site 108	Lake Villa	Illinois
United States	Bausch Site 104	Lakeway	Texas
United States	Bausch Site 106	Largo	Florida
United States	Bausch Site 121	Long Beach	California
United States	Bausch Site 107	Memphis	Tennessee
United States	Bausch Site 102	Mission Hills	California
United States	Bausch Site 109	Nashville	Tennessee
United States	Bausch Site 101	Newport Beach	California
United States	Bausch Site 114	Raleigh	North Carolina
United States	Bausch Site 116	Rancho Cordova	California
United States	Bausch Site 111	Saint Louis	Missouri
United States	Bausch Site 118	San Antonio	Texas
United States	Bausch Site 125	Scottsdale	Arizona
United States	Bausch Site 128	Slingerlands	New York
United States	Bausch Site 117	Tampa	Florida
United States	Bausch Site 103	Torrance	California
United States	Bausch Site 123	Torrance	California
United States	Bausch Site 126	Winchester	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Bausch & Lomb Incorporated

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Ocular and Non-ocular Adverse Events		12 months