A Phase 2/3 interventional study of TP-03, 0.25% and TP-03 Vehicle in Blepharitis, sponsored by Tarsus Pharmaceuticals, Inc.. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-12-21.
Sponsored by Tarsus Pharmaceuticals, Inc. · Phase 2/3, Interventional, and Treatment
The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, to its vehicle control for the treatment of blepharitis due to Demodex, a microscopic mite frequently found in human hair follicles. The hypothesis for the study is the proportion of participants cured at Day 43 with treatment by TP-03, 0.25%, is greater than the proportion cured by treatment with its vehicle.
This Phase 2b/3 study is a randomized, controlled, multicenter, double-masked, parallel trial to compare the safety and efficacy of TP-03, 0.25%, to vehicle control for the treatment of Demodex blepharitis. The primary objective of the study is to assess the safety and efficacy of TP-03 compared to its vehicle from Day 1 to Day 43 in adult participants with mild to severe Demodex blepharitis. The primary efficacy endpoint will be cure based upon collarettes. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity, intraocular pressure, slit lamp biomicroscopy and dilated ophthalmoscopy findings.
73 studies on the registry are indexed under Blepharitis; 9 are open to participants now.
This study's enrollment of 421 is above the median of 60 across 65 interventional studies indexed under Blepharitis.
Browse Blepharitis studies →Tarsus Pharmaceuticals, Inc. is the lead sponsor of 13 studies on the registry; 2 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
TP-03, lotilaner ophthalmic solution, 0.25%, administered topically twice a day for approximately 43 days
Drug: TP-03, 0.25%
Vehicle of TP-03 ophthalmic solution, administered topically twice a day for approximately 43 days
Drug: TP-03 Vehicle
TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day
Also known as: Lotilaner ophthalmic solution, 0.25%
Vehicle of TP-03 ophthalmic solution, administered twice a day
Proportion of Participants Cured Based on a Collarette Score at Day 43.
The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
Time frame: 43 days
The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43
The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values
Time frame: 43 days
Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43.
The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
Time frame: 43 days
| Milestone | Active | Control |
|---|---|---|
| Started | 212 | 209 |
| Completed | 208 | 203 |
| Not completed | 4 | 6 |
The proportion of participants cured where cure is defined as 0-2 lashes with collarettes on the upper eyelid of the analysis eye. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
| Proportion cured | Active | Control |
|---|---|---|
| Proportion of Participants Cured Based on a Collarette Score at Day 43. | 0.439 ± 0.034 | 0.072 ± 0.018 |
The proportion of participants with Demodex mites eradicated at Day 43 where eradication is defined as a mite density of 0 mites/lash for the analysis eye. The mite density is obtained by epilating four of more lashes and dividing the number of mites observed under the microscope by the number of lashes. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values
| Proportion eradicated | Active | Control |
|---|---|---|
| The Proportion of Participants With Eradication of Demodex Mites in the Analysis Eye at Day 43 | 0.677 ± 0.032 | 0.173 ± 0.026 |
The proportion of participants cured where cure is defined as a composite of the collarettes, 0-2 lashes with collarettes on the upper eyelid of the analysis eye, and normal lid margin erythema for the upper eyelid of the analysis eye at Day 43. The primary outcome analysis is the combined result from 20 analyses each with missing data imputed. Missing data were imputed per the method described in the SAP. The least square mean is computed from the result of the 20 analyses with imputed missing values.
| Proportion cured | Active | Control |
|---|---|---|
| Proportion of Participants Cured Based on a Composite Collarette and Erythema Score of 0 in the Analysis Eye at Day 43. | 0.139 ± 0.024 | 0.01 ± 0.007 |
Collected over 57 days. Non-serious events are listed at a 1% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active | 0/212 (0%) | 3/212 (1.4%) | 37/212 (17.5%) |
| Control | 0/209 (0%) | 1/209 (0.5%) | 39/209 (18.7%) |
| Event | Active | Control |
|---|---|---|
| Vascular access site pseudoaneurysmInjury, poisoning and procedural complications | 0/212 | 1/209 |
| COVID-19Infections and infestations | 1/212 | 0/209 |
| PneumoniaInfections and infestations | 1/212 | 0/209 |
| HaematuriaRenal and urinary disorders | 1/212 | 0/209 |
| Event | Active | Control |
|---|---|---|
| Instillation site painGeneral disorders | 25/212 | 16/209 |
| Instillation site pruritusGeneral disorders | 3/212 | 7/209 |
| Visual acuity reducedEye disorders | 6/212 | 6/209 |
| Eye painEye disorders | 3/212 | 3/209 |
| ChalazionEye disorders | 1/212 | 3/209 |
| Eye dischargeEye disorders | 3/212 | 2/209 |
| Vision blurredEye disorders | 2/212 | 2/209 |
| Eye pruritusEye disorders | 1/212 | 2/209 |
| Swelling of eyelidEye disorders | 1/212 | 2/209 |
| Age, Categorical(Participants) | Active | Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 86 | 65 | 151 |
| >=65 years | 126 | 144 | 270 |
| Age, Continuous(years) | Active | Control | Total |
|---|---|---|---|
| Mean | 66.1 ± 12.09 | 67.8 ± 12.63 | 67.0 ± 12.37 |
| Sex: Female, Male(Participants) | Active | Control | Total |
|---|---|---|---|
| Female | 123 | 117 | 240 |
| Male | 89 | 92 | 181 |
| Ethnicity (NIH/OMB)(Participants) | Active | Control | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 11 | 25 |
| Not Hispanic or Latino | 198 | 198 | 396 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Active | Control | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 3 | 2 | 5 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 11 | 16 | 27 |
| White | 195 | 187 | 382 |
| More than one race | 2 | 3 | 5 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Active | Control | Total |
|---|---|---|---|
| United States | 212 | 209 | 421 |
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Studies of the drug tested here: TP-03
Tarsus Pharmaceuticals, Inc.