A Study to Evaluate TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis

Phase 1

Completed

• Conditions: Non-infectious Anterior Uveitis
• Interventions: Drug: TRS01 eye drops

• Registration Number: NCT04222712
• Lead Sponsor: Tarsier Pharma

Brief Summary

The objective of this study is to evaluate the safety of TRS01 eye drops in participants with active non-infectious anterior uveitis

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Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-07
• Study First Submitted QC: 2020-01-07
• Study First Posted: 2020-01-10
• Study Start: 2020-02-01
• Primary Completion: 2020-08-24
• Study Completion: 2020-08-24
• Disposition First Submitted: 2021-08-18
• Status Verified: 2023-08
• Results First Submitted: 2023-08-16
• Results First Submitted QC: 2023-10-04
• Last Update Submitted: 2023-10-04
• Results First Posted: 2023-10-05
• Disposition First Posted: 2023-10-05
• Last Update Posted: 2023-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• 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.
• Diagnosed with active non-infectious anterior uveitis requiring an increase or initiation of topical steroids for management of ocular inflammation.

An eligible subject must have:

• Non-infectious active anterior uveitis with anterior chamber cells Grade 2 or Grade 3, as specified per protocol.
• Must have vision ≥ 20/40 in the non-study eye.
• Use adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol.

Exclusion Criteria

• Any form of infectious uveitis
• Active retinitis
• Cancer or melanoma that is actively treated with immunotherapy
• Pregnancy / lactation
• Receiving specific medication/interventions as specified per protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TRS01 low dose	TRS01 eye drops	-
TRS01 high dose	TRS01 eye drops	-

Primary Outcome Measures

Name	Time	Method
Assessment of Both Systemic and Ocular Adverse Events	10 weeks	Number of patients experiencing Adverse Events during the study

Trial Locations

Locations (2)

Palisades Park; 🇺🇸 Palisades Park, New Jersey, United States

San Antonio; 🇺🇸 San Antonio, Texas, United States