Trial · NCT03925727
Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
NCT03925727, Phase 3, Completed, Mimetogen Pharmaceuticals USA, Inc.; results first posted 2023-03-09
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tavilermide Ophthalmic Solution for the Treatment of Dry Eye. Trials, record NCT03925727. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03925727
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tavilermide Ophthalmic Solution for the Treatment of Dry Eye
- NCT number
- NCT03925727
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 623 participants, actual
- Lead sponsor
- Mimetogen Pharmaceuticals USA, Inc.
- Conditions
- Keratoconjunctivitis Sicca, Dry Eye
- Interventions
- Tavilermide ophthalmic solution, Placebo
- First posted
- 2019-04-24
- Last updated
- 2023-04-05
- Results first posted
- 2023-03-09
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Eye Dryness Score as Measured by the VAS | 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. |
| Primary | Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Eye Dryness Score as Measured by the VAS | Baseline to Day 85 in 5% Tavilermide versus Placebo | ITT Population with Markov Chain Monte Carlo (MCMC) on all randomized subjects | score on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale | Baseline to Day 85 in 5% Tavilermide versus Placebo | ITT Population with MCMC on all randomized subjects | units on a scale | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Eye Dryness Score as Measured by the VAS | Tavilermide 5% | -15.1 | Standard Error 1.64 | score on a scale | |
| Change From Baseline in Eye Dryness Score as Measured by the VAS | Tavilermide 1% | -20.6 | Standard Error 2.66 | score on a scale | |
| Change From Baseline in Eye Dryness Score as Measured by the VAS | Placebo | -16.5 | Standard Error 1.67 | score on a scale | |
| Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale | Tavilermide 5% | -2.6 | Standard Error 0.17 | units on a scale | |
| Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale | Tavilermide 1% | -2.3 | Standard Error 0.28 | units on a scale | |
| Change From Baseline in Total Corneal Fluorescein Staining as Measured by the NEI Scale | Placebo | -2.1 | Standard Error 0.17 | units on a scale |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Tavilermide 5% | 263 | |
| Overall Study | STARTED | Tavilermide 1% | 100 | |
| Overall Study | STARTED | Placebo | 260 | |
| Overall Study | COMPLETED | Tavilermide 5% | 244 | |
| Overall Study | COMPLETED | Tavilermide 1% | 94 | |
| Overall Study | COMPLETED | Placebo | 242 | |
| Overall Study | NOT COMPLETED | Tavilermide 5% | 19 | |
| Overall Study | NOT COMPLETED | Tavilermide 1% | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 18 |
Source ClinicalTrials.gov
Adverse events18
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Instillation site pain | General disorders | Tavilermide 5% | 16 | 261 | 25 |
| other | Instillation site pain | General disorders | Tavilermide 1% | 1 | 99 | 1 |
| other | Instillation site pain | General disorders | Placebo | 8 | 255 | 8 |
| serious | Cerebrovascular accident | Nervous system disorders | Tavilermide 5% | 1 | 261 | 1 |
| serious | Cerebrovascular accident | Nervous system disorders | Tavilermide 1% | 0 | 99 | 0 |
| serious | Cerebrovascular accident | Nervous system disorders | Placebo | 0 | 255 | 0 |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | Tavilermide 5% | 1 | 261 | 1 |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | Tavilermide 1% | 0 | 99 | 0 |
| serious | Lymphadenopathy | Blood and lymphatic system disorders | Placebo | 0 | 255 | 0 |
| serious | Osteomyelitis | Infections and infestations | Tavilermide 5% | 0 | 261 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tavilermide 5% | 1 | 261 |
| Total, all-cause mortality | Tavilermide 1% | 0 | 99 |
| Total, all-cause mortality | Placebo | 0 | 255 |
| Total, other adverse events | Tavilermide 5% | 16 | 261 |
| Total, other adverse events | Tavilermide 1% | 1 | 99 |
| Total, other adverse events | Placebo | 8 | 255 |
| Total, serious adverse events | Tavilermide 5% | 2 | 261 |
| Total, serious adverse events | Tavilermide 1% | 0 | 99 |
| Total, serious adverse events | Placebo | 3 | 255 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03925727
GET https://conductscience.org/api/trials/v1/NCT03925727/registered