Dry Eye Disease (DED)Phase 3NCT04139798
Perfluorohexylcotane (NOV03) for the Treatment of Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
A Phase 3 study testing NOV03 in people with Dry Eye Disease (DED), run by Bausch & Lomb Incorporated at 29 sites in United States.
Trial 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). 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?
- Yes, some participants may receive a placebo
- How many people
- 599 participants
- Where
- 29 sitesUnited States
- Study dates
- 20 Jul 2020to 12 Mar 2021
- 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 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
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
29 sites in 1 country.
29 sites in 1 country
United States29 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 105
Round Rock, Texas, 78681
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
103
Torrance, California, 90505
Bausch Site 123
Torrance, California, 90505
Bausch Site 126
Winchester, Massachusetts, 01890
About this study
Official title: A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of NOV03 (Perfluorohexyloctane) on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
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).
- Conditions
- Dry Eye Disease (DED)
- Being tested
- NOV03, Placebo
- 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
PlaceboDrug
Saline solution (0.6% sodium chloride solution)
| Study group | Role | What they receive |
|---|---|---|
| NOV03 4 times daily (QID) | Experimental | 100% Perfluorohexyloctance solution 4 times daily (QID) Receives: Drug: NOV03 |
| Placebo 4 times daily (QID) | Placebo comparator | Saline solution (0.6% sodium chloride solution) 4 times daily (QID) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57
Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.
Measured: Assessed from Baseline to Day 57
Change From Baseline of Dryness Score at Day 57
Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).
Measured: Assessed from Baseline to Day 57
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2019
- Study start20 Jul 2020
- Primary completion12 Mar 2021
- Study completion12 Mar 2021
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 (2)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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 599 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch & Lomb Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson Varughese, Study director, Bausch Health Americas, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04139798
- Sponsor's protocol ID
- NVU-003 (Gobi)
- Status last verified
- Aug 2024
- First submitted
- 23 Oct 2019
- Last updated
- 23 Oct 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Fahmy AM, Harthan JS, Evans DG, Greiner JV, Tauber J, Sheppard JD, Krosser S, Vittitow JL. Perfluorohexyloctane ophthalmic solution for dry eye disease: pooled analysis of two phase 3 clinical trials. Front Ophthalmol (Lausanne). 2024 Nov 5;4:1452422. doi: 10.3389/fopht.2024.1452422. eCollection 2024.
PubMed 39564145Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
PubMed 36729473
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multi-Center, Randomized, Double-Masked, Saline-Controlled Trial to Evaluate the Effect of NOV03 (Perfluorohexyloctane) on Signs and Symptoms of Dry Eye Disease Associated With Meibomian Gland Dysfunction (Gobi Study)
- ClinicalTrials.gov ID
- NCT04139798
- Acronym / sponsor ID
- NVU-003 (Gobi)
- Conditions
- Dry Eye Disease (DED)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 599 participants (actual)
- Lead sponsor
- Bausch & Lomb IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 12 Mar 2021 (actual)
- Study completion
- 12 Mar 2021 (actual)
- First posted
- 25 Oct 2019 (actual)
- Results
- Posted 23 Oct 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NOV03 4 times daily (QID) | Experimental | Drug: NOV03100% Perfluorohexyloctance solution 4 times daily (QID) |
| Placebo 4 times daily (QID) | Placebo comparator | Drug: PlaceboSaline solution (0.6% sodium chloride 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 and Visit 1
- 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) |
| PlaceboSaline solution (0.6% sodium chloride solution) | Drug | Placebo 4 times daily (QID) |
Primary outcome
Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57
Time frame: Assessed from Baseline to Day 57
Corneal Fluorescein Staining (tCFS) is graded based on the NEI scale. The NEI scale divides the cornea in 5 subregions: central, inferior, superior, nasal, temporal. The score for each region ranges from 0-3; 0 corresponds to no staining, 3 corresponds to maximum staining. The total score is the sum of the 5 subregions ranging from 0-15.
Change From Baseline of Dryness Score at Day 57
Time frame: Assessed from Baseline to Day 57
Dryness Score is rated on a visual analogue scale (VAS) ranging from 0-100; 0 corresponds to no discomfort and 100 to maximum discomfort).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39564145Fahmy AM, Harthan JS, Evans DG, Greiner JV, Tauber J, Sheppard JD, Krosser S, Vittitow JL. Perfluorohexyloctane ophthalmic solution for dry eye disease: pooled analysis of two phase 3 clinical trials. Front Ophthalmol (Lausanne). 2024 Nov 5;4:1452422. doi: 10.3389/fopht.2024.1452422. eCollection 2024.
- Derived from this study: PubMed 36729473Mangwani-Mordani S, Goodman CF, Galor A. Novel Treatments for Chronic Ocular Surface Pain. Cornea. 2023 Mar 1;42(3):261-271. doi: 10.1097/ICO.0000000000003193. Epub 2022 Dec 19.
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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.
29 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 29 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 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 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. Some participants in this study may receive a placebo. 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 23 Oct 2024). 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?
Change From Baseline (CFB) in Total Corneal Fluorescein Staining (tCFS) at Day 57 (time frame: Assessed from Baseline to Day 57). The study lists 2 primary outcomes in all. 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 NCT04139798, which also lists 2 linked publications.
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 23 Oct 2024.