FindTrial
Sign In

A Study of TRS01 in Participants With Post-surgical Ocular Inflammation

A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation

Status
Completed
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04222725
Enrollment
37
Registered
2020-01-10
Start date
2020-02-01
Completion date
2020-07-17
Last updated
2021-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post Surgical Ocular Inflammation

Keywords

postoperative, postsurgical, ocular, inflammation, pain

Brief summary

The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.

Interventions

DRUGTRS01 eye drops

Dosed 4 times a day (QID)

DRUGPlacebo eye drops

Dosed QID

Sponsors

Tarsier Pharma
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are: * 18 years of age or older. * Able to provide informed consent, follow instructions and complete all required study visits for the duration of the study. * Scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (IOL) implantation, and not combined with any other surgery. * Have vision ≥ 20/200 in the non-study eye. * Able to self-administer eye drops (tested during screening by self-administration of artificial tears), or have a care provider that can administer the drops. * Have no known sensitivity /allergy to the TRS01 or formulation excipients. * Using adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol * Randomization inclusion criteria as specified per protocol.

Exclusion criteria

* Scheduled to undergo cataract surgery in the non-study eye for the duration of the study. * Receiving specific medication/interventions as specified per protocol

Design outcomes

Primary

MeasureTime frameDescription
Assessment of Both Systemic and Ocular Adverse Events14 daysNumber of adverse events that occurred during the study

Countries

United States

Participant flow

Participants by arm

ArmCount
TRS01 Low Dose
TRS01 eye drops: Dosed 4 times a day (QID)
8
TRS01 Medium Dose
TRS01 eye drops: Dosed QID
10
TRS01 High Dose
TRS01 eye drops: Dosed QID
9
Placebo
Placebo eye drops: Dosed QID
10
Total37

Withdrawals & dropouts

PeriodReasonFG000FG001FG002FG003
Overall StudyAdverse Event0100

Baseline characteristics

CharacteristicTRS01 Low DoseTRS01 Medium DoseTRS01 High DosePlaceboTotal
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
4 Participants5 Participants9 Participants6 Participants24 Participants
Age, Categorical
Between 18 and 65 years
4 Participants5 Participants0 Participants4 Participants13 Participants
Age, Continuous65.1 years
STANDARD_DEVIATION 10.11
63.8 years
STANDARD_DEVIATION 7.77
74.9 years
STANDARD_DEVIATION 5.84
67.0 years
STANDARD_DEVIATION 7.79
67.6 years
STANDARD_DEVIATION 8.74
Anterior Chamber Cell Grade in the Study Eye
2 (6-15 Cells)
3 Participants3 Participants3 Participants4 Participants13 Participants
Anterior Chamber Cell Grade in the Study Eye
3 (16-30 Cells)
3 Participants6 Participants3 Participants4 Participants16 Participants
Anterior Chamber Cell Grade in the Study Eye
4 (>30 Cells)
2 Participants1 Participants3 Participants2 Participants8 Participants
Iris Color
Blue
3 Participants2 Participants2 Participants1 Participants8 Participants
Iris Color
Dark Brown
5 Participants5 Participants5 Participants8 Participants23 Participants
Iris Color
Gray
0 Participants1 Participants0 Participants0 Participants1 Participants
Iris Color
Hazel
0 Participants1 Participants0 Participants1 Participants2 Participants
Iris Color
Light Brown
0 Participants1 Participants2 Participants0 Participants3 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
2 Participants2 Participants2 Participants3 Participants9 Participants
Race (NIH/OMB)
Black or African American
1 Participants1 Participants1 Participants1 Participants4 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
5 Participants7 Participants6 Participants6 Participants24 Participants
Sex: Female, Male
Female
6 Participants7 Participants6 Participants7 Participants26 Participants
Sex: Female, Male
Male
2 Participants3 Participants3 Participants3 Participants11 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
0 / 80 / 100 / 90 / 10
other
Total, other adverse events
0 / 82 / 100 / 90 / 10
serious
Total, serious adverse events
0 / 80 / 100 / 90 / 10

Outcome results

Primary

Assessment of Both Systemic and Ocular Adverse Events

Number of adverse events that occurred during the study

Time frame: 14 days

Population: All randomized subjects who took at least 1 dose of study drug

ArmMeasureValue (NUMBER)
TRS01 Low DoseAssessment of Both Systemic and Ocular Adverse Events0 Number of TEAE
TRS01 Medium DoseAssessment of Both Systemic and Ocular Adverse Events3 Number of TEAE
TRS01 High DoseAssessment of Both Systemic and Ocular Adverse Events0 Number of TEAE
PlaceboAssessment of Both Systemic and Ocular Adverse Events0 Number of TEAE

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026