A Phase 3 interventional study of Tavilermide ophthalmic solution and Placebo in Keratoconjunctivitis Sicca and Dry Eye, sponsored by Mimetogen Pharmaceuticals USA, Inc.. Completed at 22 sites in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-04-05.
Sponsored by Mimetogen Pharmaceuticals USA, Inc. · Phase 3, Interventional, and Treatment
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.
85 studies on the registry are indexed under Keratoconjunctivitis Sicca; 1 is open to participants now.
This study's enrollment of 623 is above the median of 82 across 75 interventional studies indexed under Keratoconjunctivitis Sicca.
Browse Keratoconjunctivitis Sicca studies →Mimetogen Pharmaceuticals USA, Inc. is the lead sponsor of 6 studies on the registry; none are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Tavilermide ophthalmic solution
Drug: Tavilermide ophthalmic solution
Other: Placebo
BID topical dosing
BID topical dosing
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.
Time frame: 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.
Time frame: Baseline to Day 85 in 5% Tavilermide versus Placebo
| Milestone | Tavilermide 5% | Tavilermide 1% | Placebo |
|---|---|---|---|
| Started | 263 | 100 | 260 |
| Completed | 244 | 94 | 242 |
| Not completed | 19 | 6 | 18 |
| Withdrew: Adverse event | 4 | 0 | 3 |
| Withdrew: Protocol violation | 1 | 2 | 2 |
| Withdrew: Withdrawal by subject | 3 | 2 | 4 |
| Withdrew: Administrative reasons | 3 | 1 | 2 |
| Withdrew: Randomized in error or disqualified | 8 | 1 | 7 |
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.
| score on a scale | Tavilermide 5% | Tavilermide 1% | Placebo |
|---|---|---|---|
| Change From Baseline in Eye Dryness Score as Measured by the VAS | -15.1 ± 1.64 | -20.6 ± 2.66 | -16.5 ± 1.67 |
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.
| units on a scale | Tavilermide 5% | Tavilermide 1% | Placebo |
|---|---|---|---|
| Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale | -2.6 ± 0.17 | -2.3 ± 0.28 | -2.1 ± 0.17 |
Collected over 12 weeks. Non-serious events are listed at a 3% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Tavilermide 5% | 1/261 (0.4%) | 2/261 (0.8%) | 16/261 (6.1%) |
| Tavilermide 1% | 0/99 (0%) | 0/99 (0%) | 1/99 (1%) |
| Placebo | 0/255 (0%) | 3/255 (1.2%) | 8/255 (3.1%) |
| Event | Tavilermide 5% | Tavilermide 1% | Placebo |
|---|---|---|---|
| OsteomyelitisInfections and infestations | 0/261 | 0/99 | 1/255 |
| Breast cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/261 | 0/99 | 1/255 |
| Knee arthroplastySurgical and medical procedures | 0/261 | 0/99 | 1/255 |
| Cerebrovascular accidentNervous system disorders | 1/261 | 0/99 | 0/255 |
| LymphadenopathyBlood and lymphatic system disorders | 1/261 | 0/99 | 0/255 |
| Event | Tavilermide 5% | Tavilermide 1% | Placebo |
|---|---|---|---|
| Instillation site painGeneral disorders | 16/261 | 1/99 | 8/255 |
Intent-to-treat (ITT) set included all randomized participants
| Age, Continuous(Years) | Tavilermide 5% | Tavilermide 1% | Vehicle | Total |
|---|---|---|---|---|
| Mean | 61.1 ± 13.47 | 59.7 ± 14.63 | 60.5 ± 14.00 | 60.6 ± 13.87 |
| Sex: Female, Male(Participants) | Tavilermide 5% | Tavilermide 1% | Vehicle | Total |
|---|---|---|---|---|
| Female | 201 | 80 | 184 | 465 |
| Male | 56 | 17 | 69 | 142 |
| Ethnicity (NIH/OMB)(Participants) | Tavilermide 5% | Tavilermide 1% | Vehicle | Total |
|---|---|---|---|---|
| Hispanic or Latino | 25 | 9 | 29 | 63 |
| Not Hispanic or Latino | 232 | 88 | 224 | 544 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Tavilermide 5% | Tavilermide 1% | Vehicle | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 3 | 2 | 2 | 7 |
| Asian | 11 | 5 | 8 | 24 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 21 | 8 | 27 | 56 |
| White | 219 | 81 | 213 | 513 |
| More than one race | 0 | 1 | 2 | 3 |
| Unknown or Not Reported | 3 | 0 | 1 | 4 |
| Eye Dryness Score(units on a scale) | Tavilermide 5% | Tavilermide 1% | Vehicle | Total |
|---|---|---|---|---|
| Mean | 63.3 ± 20.38 | 65.8 ± 19.06 | 65.0 ± 20.22 | 64.4 ± 20.10 |
| Total Corneal Fluorescein Staining(units on a scale) | Tavilermide 5% | Tavilermide 1% | Vehicle | Total |
|---|---|---|---|---|
| Mean | 7.4 ± 1.92 | 7.4 ± 1.77 | 7.6 ± 2.06 | 7.5 ± 1.96 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tavilermide
Mimetogen Pharmaceuticals USA, Inc.