Dry Eye Disease (DED)Phase 3NCT04140227

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

A Phase 3 study testing NOV03 in people with Dry Eye Disease (DED), run by Bausch & Lomb Incorporated at 28 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Dry Eye Disease (DED)
What is being tested?: NOV03
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 256 participants
Where: 28 sitesUnited States
Study dates: 24 Sep 2020to 5 Jan 2022
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

28 sites in 1 country.

City, postcode or hospital

28 sites in 1 country

United States28 sites

Bausch Site 124
Birmingham, Alabama, 35233
Bausch Site 122
Cranberry Township, Pennsylvania, 16066
Bausch Site 127
Danbury, Connecticut, 06810
Bausch Site 119
Edgewood, Kentucky, 41017
Bausch Site 120
El Paso, Texas, 79902
Bausch Site 129
Fort Myers, Florida, 33901
Bausch Site 110
Glendale, California, 91204
Bausch Site 112
Indianapolis, Indiana, 46260
Bausch Site 115
Jacksonville, Florida, 32256
Bausch Site 113
Kansas City, Missouri, 64111
Bausch Site 108
Lake Villa, Illinois, 60046
Bausch Site 104
Lakeway, Texas, 78738
Bausch Site 106
Largo, Florida, 33773
Bausch Site 121
Long Beach, California, 90805
Bausch Site 107
Memphis, Tennessee, 38119
Bausch Site 102
Mission Hills, California, 91345
Bausch Site 109
Nashville, Tennessee, 37205
Bausch Site 101
Newport Beach, California, 92663
Bausch Site 114
Raleigh, North Carolina, 27603
Bausch Site 116
Rancho Cordova, California, 95670
Bausch Site 118
San Antonio, Texas, 78229
Bausch Site 125
Scottsdale, Arizona, 85254
Bausch Site 128
Slingerlands, New York, 12159
Bausch Site 111
St Louis, Missouri, 63131
Bausch Site 117
Tampa, Florida, 33603
Bausch Site 103
Torrance, California, 90505
Bausch Site 123
Torrance, California, 90505
Bausch Site 126
Winchester, Massachusetts, 01890

Other trials in United States

About this study

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)

Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.

Read the detailed description

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)
Being tested: NOV03
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NOV03Drug
100% Perfluorohexyloctane

Study groups in NCT04140227
Study group	Role	What they receive
NOV03 4 times daily (QID)	Experimental	100% Perfluorohexyloctance solution 4 times daily (QID) Receives: Drug: NOV03

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Ocular and Non-ocular Adverse Events
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

24 Sep 20205 Jan 2022

First posted25 Oct 2019
Study start24 Sep 2020
Primary completion5 Jan 2022
Study completion5 Jan 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 256 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04140227
Sponsor's protocol ID: NVU-004 (Kalahari)
Status last verified: Jan 2022
First submitted: 23 Oct 2019
Last updated: 4 Mar 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No

Publications

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.
PubMed 37921522

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity

All Dry Eye Disease (DED) trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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)
ClinicalTrials.gov ID: NCT04140227
Acronym / sponsor ID: NVU-004 (Kalahari)
Conditions: Dry Eye Disease (DED)
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 256 participants (actual)
Lead sponsor: Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
Study start: 24 Sep 2020 (actual)
Primary completion: 5 Jan 2022 (actual)
Study completion: 5 Jan 2022 (actual)
First posted: 25 Oct 2019 (actual)
Results: Posted 29 Dec 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.

Detailed description

Further objective is to evaluate the efficacy of perfluorohexyloctane (NOV03) solution during long-term use in subjects with DED associated with MGD.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
NOV03 4 times daily (QID)	Experimental	Drug: NOV03100% Perfluorohexyloctance solution 4 times daily (QID)

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NOV03100% Perfluorohexyloctane	Drug	NOV03 4 times daily (QID)

Primary outcome

Number of Participants With Ocular and Non-ocular Adverse Events
Time frame: 12 months

Results and safety

Results posted to the registry on 29 Dec 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NOV03 4 Times Daily (QID)	256	208

Primary outcome: Number of Participants With Ocular and Non-ocular Adverse Events

Time frame: 12 months. Count of participants. Unit: Participants

Measure	NOV03 4 Times Daily (QID) n = 208
At Least 1 TEAE Ocular and non-Ocular	69
At Least 1 IP-related TEAE Ocular and non-Ocular	14
At Least 1 SAE Ocular and non-Ocular	1
TEAE that led to Drug Withdrawal	9

Adverse events

Time frame: AE information was captured during the duration of the study of 1 year. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NOV03 4 Times Daily (QID)	10 of 208 (4.8%)	44 of 208 (21.2%)	1 of 208

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37921522Protzko 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.

Related trials for Dry Eye Disease (DED)

Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Not yet recruitingEarly Phase 1
a Novel siRNA Eyedrops for DED Treatment
Dry Eye
Active, not recruiting
Clinical Study Evaluating Nordlys™ SWT IPL for Dry Eye Disease (DED) Due to MGD
Meibomian Gland Dysfunction, Dry Eye Disease
Recruiting
Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
Dry Eye Disease (DED), Contact Lens Discomfort (CLD)
Not yet recruitingPhase 1
A Clinical Study to Evaluate the Safety and Effectiveness of MSCohi-O Lens in the Treatment of Immune-related Ocular Surface Diseases.
Keratitis, Autoimmunity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Johnson Varughese study director

Bausch Health Americas, Inc.

28 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing NOV03 in people with Dry Eye Disease (DED), run by Bausch & Lomb Incorporated at 28 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 28 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Ocular and Non-ocular Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04140227, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2024.