Keratoconjunctivitis SiccaPhase 3NCT03925727

Tavilermide Ophthalmic Solution for the Treatment of Dry Eye

A Phase 3 study testing Tavilermide ophthalmic solution in people with Keratoconjunctivitis Sicca and Dry Eye, run by Mimetogen Pharmaceuticals USA, Inc. at 22 sites in United States.

Completed

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

Official record

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Trial summary

The purpose of this study is to assess the safety and efficacy of 5% tavilermide and 1% tavilermide ophthalmic solutions compared with placebo ophthalmic solution in treating the signs and symptoms of dry eye. Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Keratoconjunctivitis Sicca, Dry Eye
What is being tested?: Tavilermide ophthalmic solution
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 623 participants
Where: 22 sitesUnited States
Study dates: 28 Mar 2019to 11 Jun 2020
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 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Subject-reported history of dry eye disease in both eyes for at least 6 months;
History of use of artificial tear eye drops for dry eye symptoms;
Total score of ≥40 on SANDE;
TFBUT;
Corneal fluorescein staining;
Lissamine green conjunctival staining;
Schirmer's test score.

Who cannot join

Have participated in a previous tavilermide (MIM-D3) study;
Have clinically significant slit lamp findings at Visit 1;
Have a history of lacrimal duct obstruction within 12 months of Visit 1;
Have an uncontrolled systemic disease;
Be a woman who is pregnant, nursing or planning a pregnancy;
Be a woman of childbearing potential who is not using an acceptable means of birth control;
Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study;
Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days prior to Visit 1.

Trial locations and contacts

22 sites in 1 country.

City, postcode or hospital

22 sites in 1 country

United States22 sites

Tavilermide Investigational Site
Boynton Beach, Florida, 33437
Tavilermide Investigational Site
Bradenton, Florida, 34209
Tavilermide Investigational Site
Cincinnati, Ohio, 45236
Tavilermide Investigational Site
Coral Springs, Florida, 33067
Tavilermide Investigational Site
Fort Collins, Colorado, 80528
Tavilermide Investigational Site
Indianapolis, Indiana, 46290
Tavilermide Investigational Site
Kenosha, Wisconsin, 53142
Tavilermide Investigational Site
Lexington, Kentucky, 40509
Tavilermide Investigational Site
Littleton, Colorado, 80120
Tavilermide Investigational Site
Los Angeles, California, 90013
Tavilermide Investigational Site
Louisville, Kentucky, 40206
Tavilermide Investigational Site
Maryville, Tennessee, 37803
Tavilermide Investigational Site
Mason, Ohio, 45040
Tavilermide Investigational Site
Nashville, Tennessee, 37205
Tavilermide Investigational Site
Newport Beach, California, 92663
Tavilermide Investigational Site
Ocala, Florida, 34474
Tavilermide Investigational Site
Phoenix, Arizona, 85032
Tavilermide Investigational Site
Rapid City, South Dakota, 57701
Tavilermide Investigational Site
San Antonio, Texas, 78248
Tavilermide Investigational Site
Shelby, North Carolina, 28150
Tavilermide Investigational Site
Sioux City, Iowa, 51104
Tavilermide Investigational Site
St Louis, Missouri, 63131

Other trials in United States

About this study

Official title: Multi-Center, Randomized,Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy Study of Tavilermide Ophthalmic Solutions for the Treatment of Dry Eye

Conditions: Keratoconjunctivitis Sicca, Dry Eye
Being tested: Tavilermide ophthalmic solution, Placebo
Medical subject headings: Keratoconjunctivitis Sicca, Dry Eye Syndromes

What participants receive

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

Tavilermide ophthalmic solutionDrug
BID topical dosing
PlaceboOther
BID topical dosing

Study groups in NCT03925727
Study group	Role	What they receive
1% Tavilermide ophthalmic solution	Experimental	Not described Receives: Drug: Tavilermide ophthalmic solution
5% Tavilermide ophthalmic solution	Experimental	Not described Receives: Drug: Tavilermide ophthalmic solution
Vehicle ophthalmic solution	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

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

Change From Baseline in Eye Dryness Score as Measured by the VAS
The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.
Measured: Baseline to Day 85 in 5% Tavilermide versus Placebo
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior) . Grade 0 was specified when no staining is present. The maximum score was 15. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.
Measured: Baseline to Day 85 in 5% Tavilermide versus Placebo

Timeline

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

28 Mar 201911 Jun 2020

First posted24 Apr 2019
Study start28 Mar 2019
Primary completion11 Jun 2020
Study completion11 Jun 2020

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.
Other trials for Keratoconjunctivitis SiccaStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 623 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03925727
Sponsor's protocol ID: MIM-728
Status last verified: Mar 2023
First submitted: 19 Apr 2019
Last updated: 5 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

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

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All Keratoconjunctivitis Sicca trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Multi-Center, Randomized,Double-Masked, Vehicle-Controlled Study to Assess the Safety and Efficacy Study of Tavilermide Ophthalmic Solutions for the Treatment of Dry Eye
ClinicalTrials.gov ID: NCT03925727
Acronym / sponsor ID: MIM-728
Conditions: Keratoconjunctivitis Sicca, Dry Eye
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 623 participants (actual)
Lead sponsor: Mimetogen Pharmaceuticals USA, Inc.Industry (pharma, biotech, devices)
Study start: 28 Mar 2019 (actual)
Primary completion: 11 Jun 2020 (actual)
Study completion: 11 Jun 2020 (actual)
First posted: 24 Apr 2019 (actual)
Results: Posted 9 Mar 2023

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
1% Tavilermide ophthalmic solution	Experimental	Drug: Tavilermide ophthalmic solution
5% Tavilermide ophthalmic solution	Experimental	Drug: Tavilermide ophthalmic solution
Vehicle ophthalmic solution	Placebo comparator	Other: Placebo

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Subject-reported history of dry eye disease in both eyes for at least 6 months;
History of use of artificial tear eye drops for dry eye symptoms;
Total score of ≥40 on SANDE;
TFBUT;
Corneal fluorescein staining;

Key exclusion criteria (8 listed)

Have participated in a previous tavilermide (MIM-D3) study;
Have clinically significant slit lamp findings at Visit 1;
Have a history of lacrimal duct obstruction within 12 months of Visit 1;
Have an uncontrolled systemic disease;
Be a woman who is pregnant, nursing or planning a pregnancy;

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
Tavilermide ophthalmic solutionBID topical dosing	Drug	1% Tavilermide ophthalmic solution, 5% Tavilermide ophthalmic solution
PlaceboBID topical dosing	Other	Vehicle ophthalmic solution

Primary outcome

Change From Baseline in Eye Dryness Score as Measured by the VAS
Time frame: Baseline to Day 85 in 5% Tavilermide versus Placebo
The Visual Analog Scale (VAS) where subjects were asked to rate their eye dryness (OU) by placing a vertical mark on the horizontal line to indicate their current level of discomfort. 0 mm corresponds to "No Discomfort," and 100 mm corresponds to "Maximal Discomfort." The length of the assessment line is 100 mm.
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
Time frame: Baseline to Day 85 in 5% Tavilermide versus Placebo
The National Eye Institute (NEI) scale is a standardized grading system of 0-3 was used for each of the 5 areas on each cornea (central, superior, temporal, nasal, and inferior) . Grade 0 was specified when no staining is present. The maximum score was 15. Study eye is the 'worse eye', defined as the eye with worse (higher) score at baseline.

Results and safety

Results posted to the registry on 9 Mar 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
Tavilermide 5%	263	244
Tavilermide 1%	100	94
Placebo	260	242

Primary outcome: Change From Baseline in Eye Dryness Score as Measured by the VAS

Time frame: Baseline to Day 85 in 5% Tavilermide versus Placebo. Least squares mean (Standard Error). Unit: score on a scale

Measure	Tavilermide 5% n = 257	Tavilermide 1% n = 97	Placebo n = 253
Value	-15.1 (1.64)	-20.6 (2.66)	-16.5 (1.67)

Tavilermide 5% vs Placebo: Mean Difference (Net): 1.4 (95% CI -3.2 to 6), p = 0.5533, ANCOVA

Population analysed: ITT Population with Markov Chain Monte Carlo (MCMC) on all randomized subjects

Primary outcome: Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale

Time frame: Baseline to Day 85 in 5% Tavilermide versus Placebo. Least squares mean (Standard Error). Unit: units on a scale

Measure	Tavilermide 5% n = 257	Tavilermide 1% n = 97	Placebo n = 253
Value	-2.6 (0.17)	-2.3 (0.28)	-2.1 (0.17)

Tavilermide 5% vs Placebo: Mean Difference (Net): -0.6 (95% CI -1.1 to -0.1), p = 0.0192, ANCOVA

Population analysed: ITT Population with MCMC on all randomized subjects

Adverse events

Time frame: 12 weeks. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tavilermide 5%	2 of 261 (0.8%)	16 of 261 (6.1%)	1 of 261
Tavilermide 1%	0 of 99 (0%)	1 of 99 (1%)	0 of 99
Placebo	3 of 255 (1.2%)	8 of 255 (3.1%)	0 of 255

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Karen Meerovitch, PhD study director

Mimetogen Pharmaceuticals

22 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 Tavilermide ophthalmic solution in people with Keratoconjunctivitis Sicca and Dry Eye, run by Mimetogen Pharmaceuticals USA, Inc. at 22 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 7 inclusion and 8 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 5 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 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 9 Mar 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?

Change From Baseline in Eye Dryness Score as Measured by the VAS (time frame: Baseline to Day 85 in 5% Tavilermide versus Placebo). 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 NCT03925727.

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 5 Apr 2023.