Blepharitis, Demodex Infestation, Meibomian Gland Dysfunction
Conditions
Keywords
Demodex
Brief summary
The purpose of this study is to compare the safety and efficacy of TP-03, 0.25%, an eyedrop, BID vs TID dosing regimens for the treatment of meibomian gland dysfunction in patients with Demodex lid infestation.
Detailed description
This Phase 2a study is a randomized, two-arm, double-masked, multicenter, parallel pilot study to compare the safety and efficacy of two dosing regimens of TP-03, BID vs TID, for the treatment of meibomian gland dysfunction in patients with Demodex lid infestation. The primary objective of the study is to assess the safety and efficacy of two dosing regimens of TP-03, 0.25% from Day 1 to Day 85 in adult participants with meibomian gland dysfunction in the presence of Demodex infestation. Efficacy will be determined by assessing lower lid meibomian gland secretion, lid margin erythema, bulbar redness, tear breakup time, ocular surface staining, and dry eye symptoms. Safety will be determined by assessing adverse effects related to the treatment as well as evaluating any changes in visual acuity and slit lamp biomicroscopy from baseline.
Interventions
DRUGTP-03
TP-03, lotilaner ophthalmic solution, 0.25%, administered twice a day in participants in the BID dosing arm and three times a day in participants in the TID dosing arm
DRUGTP-03 Vehicle
Vehicle of TP-03 ophthalmic solution, administered once a day in participants in the BID dosing arm to maintain masking between arms
Sponsors
Tarsus Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Treatment assignment (BID or TID) will be unknown to the study participant, investigators and site staff performing study assessments.
Intervention model description
Arm 1: Two doses of TP-03, 0.25% and one dose of TP-03 vehicle to maintain masking daily Arm 2: Three doses of TP-03, 0.25% daily
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Be willing to sign the informed consent and deemed capable of complying with the requirements of the study protocol * Meets all of the following criteria in at least one eye: have more than 10 lashes with collarettes present on the upper lid; have the presence of one or more mites in the upper and lower lids; have evidence of meibomian gland dysfunction; have at least mild erythema of the lower lid; have a tear breakup time of less than 10 seconds; and have intact partial to full meibomian glands in at least 33% of the total meibomian gland area of the lower lid
Exclusion criteria
* Have used lid hygiene products within 7 days of Day 1 or unwilling to forego the use of lid hygiene products during the study * Have used systemic antihistamines within 30 days of Day 1 * Have used artificial eyelashes, eyelash extensions or had other cosmetic eyelash or eyelid procedures within 7 days of Day 1 or be unwilling to forego their use during the study * Contact lens wear within 7 days of Day 1 or unwilling to forego contact lens wear for the duration of the study * Be pregnant or lactating at Day 1
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 85 days | Number of participants with TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Lower Lid Meibomian Gland Secretion Score at Day 85 | Day 85 visit | For each of the 15 glands expressed, meibomian gland secretion characteristics were graded via slit lamp examination on a scale of 0 to 3 (0=worst, 3=best). Total meibomian gland secretion score is the sum of the grades for all 15 glands with a range from 0 to 45 |
| Change From Baseline in Lid Margin Erythema (Upper Eyelid) at Day 85 | Day 85 visit | Erythema of the eyelid margin was assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe). |
Countries
United States
Participant flow
Pre-assignment details
The protocol stated up to 40 subjects to be enrolled. A total of 39 subjects were enrolled in the study which adhered to the protocol.
Participants by arm
| Arm | Count |
|---|---|
| BID Dosing TP-03, lotilaner ophthalmic solution, 0.25% administered topically twice a day and TP-03 vehicle administered once a day | 21 |
| TID Dosing TP-03, lotilaner ophthalmic solution, 0.25% administered topically three times a day | 18 |
| Total | 39 |
Baseline characteristics
| Characteristic | BID Dosing | TID Dosing | Total |
|---|---|---|---|
| Age, Continuous | 61.2 years STANDARD_DEVIATION 15.74 | 66.6 years STANDARD_DEVIATION 13.13 | 63.7 years STANDARD_DEVIATION 14.66 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 2 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 19 Participants | 16 Participants | 35 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 18 Participants | 15 Participants | 33 Participants |
| Region of Enrollment United States | 21 participants | 18 participants | 39 participants |
| Sex: Female, Male Female | 12 Participants | 11 Participants | 23 Participants |
| Sex: Female, Male Male | 9 Participants | 7 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 18 |
| other Total, other adverse events | 8 / 21 | 1 / 18 |
| serious Total, serious adverse events | 1 / 21 | 0 / 18 |
Outcome results
Primary
Number of Participants With Treatment Emergent Adverse Events (TEAEs)
Number of participants with TEAEs related (definitely or potentially) to treatment summarized by MedDRA preferred term.
Time frame: 85 days
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BID Dosing | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 1 Participants |
| TID Dosing | Number of Participants With Treatment Emergent Adverse Events (TEAEs) | 1 Participants |
Other Pre-specified
Change From Baseline in Lid Margin Erythema (Upper Eyelid) at Day 85
Erythema of the eyelid margin was assessed via slit lamp examination and graded on a scale of 0 (normal) to 3 (severe).
Time frame: Day 85 visit
Population: The analysis eye is defined as the eye that meets all eligibility criteria and was randomized per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BID Dosing | Change From Baseline in Lid Margin Erythema (Upper Eyelid) at Day 85 | -1.1 score on a scale | Standard Deviation 0.85 |
| TID Dosing | Change From Baseline in Lid Margin Erythema (Upper Eyelid) at Day 85 | -1.0 score on a scale | Standard Deviation 0.59 |
Other Pre-specified
Change From Baseline in Lower Lid Meibomian Gland Secretion Score at Day 85
For each of the 15 glands expressed, meibomian gland secretion characteristics were graded via slit lamp examination on a scale of 0 to 3 (0=worst, 3=best). Total meibomian gland secretion score is the sum of the grades for all 15 glands with a range from 0 to 45
Time frame: Day 85 visit
Population: The analysis eye is defined as the eye that meets all eligibility criteria and was randomized per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| BID Dosing | Change From Baseline in Lower Lid Meibomian Gland Secretion Score at Day 85 | 10.5 score on a scale | Standard Deviation 6.94 |
| TID Dosing | Change From Baseline in Lower Lid Meibomian Gland Secretion Score at Day 85 | 11.7 score on a scale | Standard Deviation 7.89 |