Dry Eye SyndromesPhase 3NCT05848128
Efficacy and Safety Evaluation of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
A Phase 3 study testing 5% Tavilermide ophthalmic solution in people with Dry Eye Syndromes and Dry Eye Disease, run by Mimetogen Pharmaceuticals USA, Inc. at 29 sites in United States.
Trial summary
The purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes, Dry Eye Disease, Kerato Conjunctivitis Sicca
- What is being tested?
- 5% Tavilermide ophthalmic solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 642 participants
- Where
- 29 sitesUnited States
- Study dates
- 28 Jun 2023to 11 May 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- 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
29 sites in 1 country.
29 sites in 1 country
United States29 sites
Eye Consultants of Atlanta
Atlanta, Georgia, 30339
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017
Abrams Eye Center
Cleveland, Ohio, 44115
Scott & Christie and Associates
Cranberry Township, Pennsylvania, 16066
Nature Coast Clinical Research
Crystal River, Florida, 34429
Eye Associates of Fort Myers
Fort Myers, Florida, 33901
Oculus Research
Garner, North Carolina, 27529
Global Research Management
Glendale, California, 91204
Seidenberg Protzko Eye Associates
Havre de Grace, Maryland, 21078
Advanced Laser Vision & Surgical Institute
Houston, Texas, 77034
Price Vision Group
Indianapolis, Indiana, 46260
Bowden Eye & Associates
Jacksonville, Florida, 32256
Silverstein Eye Centers
Kansas City, Missouri, 64133
Moyes Eye Center
Kansas City, Missouri, 64154
Lake Travis Eye & Laser Center/Revolution Research
Lakeway, Texas, 78738
Shettle Eye Research
Largo, Florida, 33773
Piedmont Eye Center
Lynchburg, Virginia, 24502
Total Eye Care
Memphis, Tennessee, 38119
LoBue Laser and Eye Medical Center
Murrieta, California, 92562
Toyos Clinic
Nashville, Tennessee, 37215
Eye Research Foundation
Newport Beach, California, 92663
Eye Doctors of Arizona
Phoenix, Arizona, 85003
Kannarr Eye Care
Pittsburg, Kansas, 66762
Rochester Ophthalmological Group
Rochester, New York, 14618
The Eye Institute of Utah
Salt Lake City, Utah, 84107
PNV Clinical Research
San Antonio, Texas, 78229
Ophthalmology Associates
St Louis, Missouri, 63131
West Bay Eye Associates
Warwick, Rhode Island, 02888
James D. Branch
Winston-Salem, North Carolina, 27101
About this study
Official title: A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Clinical Study to Assess the Efficacy and Safety of 5% Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
The purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye disease.
- Being tested
- 5% Tavilermide ophthalmic solution, Vehicle ophthalmic solution
- 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.
5% Tavilermide ophthalmic solutionDrug
Twice a day topicial dosing
Vehicle ophthalmic solutionOther
Twice a day topical dosing
| Study group | Role | What they receive |
|---|---|---|
| 5% Tavilermide ophthalmic solution | Experimental | Not described Receives: Drug: 5% Tavilermide ophthalmic solution |
| Vehicle ophthalmic solution | Placebo comparator | Not described Receives: Other: Vehicle ophthalmic solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to Day 85
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2023
- Study start28 Jun 2023
- Primary completion11 May 2024
- Study completion11 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mimetogen Pharmaceuticals USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05848128
- Sponsor's protocol ID
- MIM-729
- Status last verified
- Jun 2024
- First submitted
- 27 Apr 2023
- Last updated
- 10 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Randomized, Double-Masked, Vehicle-Controlled Clinical Study to Assess the Efficacy and Safety of 5% Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT05848128
- Acronym / sponsor ID
- MIM-729
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- Mimetogen Pharmaceuticals USA, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Jun 2023 (actual)
- Primary completion
- 11 May 2024 (actual)
- Study completion
- 11 May 2024 (actual)
- First posted
- 8 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare the efficacy and safety of 5% tavilermide ophthalmic solution to placebo for the treatment of the signs and symptoms of dry eye disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 5% Tavilermide ophthalmic solution | Experimental | Drug: 5% Tavilermide ophthalmic solution |
| Vehicle ophthalmic solution | Placebo comparator | Other: Vehicle ophthalmic solution |
Who may qualify
- Ages
- 18 years and older
- 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 |
|---|---|---|
| 5% Tavilermide ophthalmic solutionTwice a day topicial dosing | Drug | 5% Tavilermide ophthalmic solution |
| Vehicle ophthalmic solutionTwice a day topical dosing | Other | Vehicle ophthalmic solution |
Primary outcome
Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale
Time frame: Baseline to Day 85
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.
Change From Baseline in Eye Dryness Score as Measured by the VAS
Time frame: Baseline to Day 85
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 5% Tavilermide ophthalmic solution in people with Dry Eye Syndromes and Dry Eye Disease, run by Mimetogen Pharmaceuticals USA, Inc. 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 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 10 Jun 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 Total Corneal Fluorescein Staining as Measured by the NEI Scale (time frame: Baseline to Day 85). 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?
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 10 Jun 2024.