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

Tarsier Pharma

Status and phase: Completed; Phase 2; Phase 1

Conditions: Non-infectious Anterior Uveitis

Treatments: Drug: TRS01 eye drops

Study type: Interventional

Funder types: Industry

Identifiers

NCT04222712

GADOT 20/20

Details and patient eligibility

About

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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Enrollment: 16 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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16 participants in 2 patient groups

TRS01 low dose

Experimental group

Treatment:

Drug: TRS01 eye drops

Drug: TRS01 eye drops

TRS01 high dose

Experimental group

Treatment:

Drug: TRS01 eye drops

Drug: TRS01 eye drops