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

• Sponsor: Tarsier Pharma (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04222712
• Collaborator: (none)
• Enrollment: 16
• Locations: 2
• Arms: 2
• Actual Duration (Months): 6.7
• Patients Per Site: 8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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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Condition or Disease	Intervention/Treatment	Phase
Non-infectious Anterior Uveitis	Drug: TRS01 eye drops; Drug: TRS01 eye drops	Phase 1/Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Feb 1, 2020
• Actual Primary Completion Date: Aug 24, 2020
• Actual Study Completion Date: Aug 24, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TRS01 low dose	Drug: TRS01 eye drops; Dosed four times a day (QID)
Experimental: TRS01 high dose	Drug: TRS01 eye drops; Dosed four times a day (QID)

Outcome Measures

Primary Outcome Measures

1. Assessment of both systemic and ocular adverse events [10 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Palisades Park	Palisades Park	New Jersey	United States	07650
2	San Antonio	San Antonio	Texas	United States	78240

Sponsors and Collaborators

• Tarsier Pharma

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tarsier Pharma
• ClinicalTrials.gov Identifier: NCT04222712
• Other Study ID Numbers: GADOT 20/20
• First Posted: Jan 10, 2020
• Last Update Posted: Aug 25, 2021
• Last Verified: Jan 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Uveitis; Uveitis, Anterior; Iridocyclitis; Ophthalmic Solutions

Study Results

No Results Posted as of Aug 25, 2021