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

Non-infectious Anterior Uveitis Clinical Trial

Official title:

A Randomized, Double-Masked, Dose-Ranging Study to Evaluate the Safety and Tolerability of TRS01 Eye Drops in Participants With Active Non-infectious Anterior Uveitis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04222712
• Other study ID #: GADOT 20/20
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 1, 2020
• Est. completion date: August 24, 2020

Study information

• Verified date: August 2023
• Source: Tarsier Pharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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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Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: August 24, 2020
• Est. primary completion date: August 24, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Iridocyclitis
• Non-infectious Anterior Uveitis
• Uveitis
• Uveitis, Anterior

Intervention

Drug:
• TRS01 eye drops
Dosed four times a day (QID)
• TRS01 eye drops
Dosed four times a day (QID)

Locations

Country	Name	City	State
United States	Palisades Park	Palisades Park	New Jersey
United States	San Antonio	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Tarsier Pharma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Both Systemic and Ocular Adverse Events	Number of patients experiencing Adverse Events during the study	10 weeks