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

NCT04222725 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: Tarsius 20202019-004327-20Grant Agreement Number 879598
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 5

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.

Conditions

Post Surgical Ocular Inflammation

Keywords

postoperative; postsurgical; ocular; inflammation; pain

Outcome Measures

Primary Outcomes (1)

• Assessment of Both Systemic and Ocular Adverse Events

  Number of adverse events that occurred during the study

  14 days

Study Arms (4)

TRS01 low dose

EXPERIMENTAL

Drug: TRS01 eye drops

TRS01 medium dose

EXPERIMENTAL

Drug: TRS01 eye drops

TRS01 high dose

EXPERIMENTAL

Drug: TRS01 eye drops

Placebo

PLACEBO COMPARATOR

Drug: Placebo eye drops

Interventions

TRS01 eye drops DRUG

Dosed 4 times a day (QID)

TRS01 low dose

Placebo eye drops DRUG

Dosed QID

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are:
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tarsier Pharma: lead

Study Sites (5)

Inglewood

Inglewood, California, 90302, United States

Location

Petaluma

Petaluma, California, 94954, United States

Location

Washington, MO

Washington, Missouri, 63090, United States

Location

New York

New York, New York, 10013, United States

Location

Cincinnati

Cincinnati, Ohio, 45242, United States

Location

MeSH Terms

Conditions

Inflammation; Pain

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Zohar Milman
• Organization: Tarsier Pharma

Zohar Milman <zohar@Tarsierpharma.com>

+972-50-8371319

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2020
• First Posted: January 10, 2020
• Study Start: February 1, 2020
• Primary Completion: July 17, 2020
• Study Completion: July 17, 2020
• Last Updated: October 14, 2021
• Results First Posted: October 14, 2021

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (5)