Non-infectious Anterior UveitisPhase 3NCT05042609
TRS4Vision - A Study of TRS01 in Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
A Phase 3 study testing TRS01 and FDA approved steroid eye drop (masked) in people with Non-infectious Anterior Uveitis and Uveitic Glaucoma, run by Tarsier Pharma at 30 sites in 3 countries.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma Read more about this study
- Who is it for?
- Ages 0 to 75 years
- Conditions the study is for
- Non-infectious Anterior Uveitis, Uveitic Glaucoma
- What is being tested?
- TRS01 and FDA approved steroid eye drop (masked)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 30 sitesin 3 countries
- Study dates
- 20 Sep 2021to 29 Jun 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- At sites in the US: Male or female up to and including 75 years of age (including all pediatric age groups). At sites in the Europe: Male or female between 18 and 70 years of age, inclusive.
- Diagnosed with active non-infectious anterior uveitis with anterior chamber cell Grade 2 (6-15 cells) or Grade 3 (16-30 cells) in the study eye that are without any treatment or with Stable Medical Therapy requiring further treatment.
- Have Best Corrected Visual Acuity (BCVA) vision ≥ 65 letters in the non-study eye using Early Treatment Diabetic Retinopathy Study (ETDRS).
Who cannot join
- Pregnant or breastfeeding females or females.
- History of or active significant ocular disease in either eye.
- Uncontrolled intraocular pressure (IOP; defined as >27mmHg) or narrow angle glaucoma in either eye and/or are at risk of angle closure with dilating.
- Poor posterior view due to limitation of dilation or media opacity that limits ability to examine the posterior segment.
- Cancer or melanoma that is actively treated with immunotherapy.
- Certain clinically significant systemic diseases or conditions.
- Receiving specific medication/interventions as specified per protocol.
Trial locations and contacts
30 sites in 3 countries.
30 sites in 3 countries
United States19 sites
Aurora
Aurora, Colorado, 80045
Austin
Austin, Texas, 78712
Boston
Boston, Massachusetts, 02114
Jacksonville
Jacksonville, Florida, 32204
La Jolla
La Jolla, California, 92093
Lakewood
Lakewood, Colorado, 80228
Los Angeles
Los Angeles, California, 90041
Los Angeles 2
Los Angeles, California, 90095-6984
Marietta
Marietta, Georgia, 30060
Nashville
Nashville, Tennessee, 37232
Norfolk
Norfolk, Virginia, 23502
Palisades Park
Palisades Park, New Jersey, 07650
Plano
Plano, Texas, 75075
San Antonio 2
San Antonio, Texas, 78238
San Antonio
San Antonio, Texas, 78240
Waltham
Waltham, Massachusetts, 02451
Washington, MO
Washington, Missouri, 63090
Winston-Salem
Winston-Salem, North Carolina, 27157
Winter Haven
Winter Haven, Florida, 33800
Germany6 sites
Bonn
Bonn, 53127
Düsseldorf
Düsseldorf, 40225
Freiburg
Freiburg im Breisgau, 79106
München
München, 80336
Munster
Münster, 48145
Tübingen
Tübingen, 72076
France5 sites
Dijon
Dijon, 21079
Lyon
Lyon, 69004
Nantes
Nantes, 44000
Paris
Paris, 75013
Paris
Paris, 75014
About this study
Official title: A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma
- Conditions
- Non-infectious Anterior Uveitis, Uveitic Glaucoma
- Being tested
- TRS01, FDA approved steroid eye drop (masked)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRS01Drug
TRS01 eye drops Dosed four times a day (QID)
FDA approved steroid eye drop (masked)Drug
FDA approved steroid eye drop Dosed four times a day (QID)
| Study group | Role | What they receive |
|---|---|---|
| TRS01 | Experimental | Not described Receives: Drug: TRS01 |
| Active comparator | Active comparator | Not described Receives: Drug: FDA approved steroid eye drop (masked) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Chamber Cell (ACC) Grade = 0 on Day 28
For FDA submission: the percentage of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye.
ACC=0 is complete resolution of inflammation (0 cells).
Measured: 28 days
Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28
For submission to European Medicines Agency (EMA) related countries: the percentage of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye.
ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells.
Measured: 28 days
Secondary outcomes (4)
Change From Baseline (Day 1) in ACC Grade on Day 28 in the Study Eye
Change from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation).
ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level
Change from baseline measures the mean change in ACC grade on Day 28 in the study eye
Measured: 28 days
Anterior Chamber Cell (ACC) Grade on Day 21
Proportion of subjects with ACC Grade=0 on Day 21 in the study eye.
Measured: 21 days
Change From Baseline in ACC Grade on Day 21.
Change from baseline in Anterior Chamber Cell (ACC) score (measures ocular inflammation).
ACC scale range: 0-4 ACC grade 0 = No cells ACC grade 4 = Severe ACC level Change from baseline measures the mean change in ACC grade on Day 21 in the study eye
Measured: 21 days
Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 21
Proportions of subjects with ACC Grade = 0 or 1 on Day 21 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start20 Sep 2021
- Primary completion29 Jun 2023
- Study completion29 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-infectious Anterior UveitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsier Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lexitas Clinical Trials, Study director, Lexitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05042609
- Sponsor's protocol ID
- TRS4Vision
- Status last verified
- Aug 2023
- First submitted
- 3 Sep 2021
- Last updated
- 22 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chu DS, Tsui E, Rifkin LM, Palestine AG, Rich C, Thorne JE, Haim-Langford D, Milman Z, Fulcher E, Neumann R, DE Smet MD; TRS4Vision Study Group. Dazdotuftide: Novel Treatment for Noninfectious Uveitis with Superior Intraocular Pressure Safety Profile: A Randomized Clinical Trial. Am J Ophthalmol. 2026 Apr;284:78-87. doi: 10.1016/j.ajo.2025.12.034. Epub 2026 Jan 2.
PubMed 41485727
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Randomized, Active-Controlled, Double-Masked Study to Evaluate the Safety and Efficacy of TRS01 Eye Drops in the Treatment of Subjects With Active Non-infectious Anterior Uveitis Including Subjects With Uveitic Glaucoma
- ClinicalTrials.gov ID
- NCT05042609
- Acronym / sponsor ID
- TRS4Vision
- Conditions
- Non-infectious Anterior Uveitis, Uveitic Glaucoma
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- Tarsier PharmaIndustry (pharma, biotech, devices)
- Study start
- 20 Sep 2021 (actual)
- Primary completion
- 29 Jun 2023 (actual)
- Study completion
- 29 Jun 2023 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Posted 20 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy and safety of TRS01 eye drops compared to active comparator in subjects with active non-infectious anterior uveitis with or without uveitic glaucoma
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TRS01 | Experimental | Drug: TRS01 |
| Active comparator | Active comparator | Drug: FDA approved steroid eye drop (masked) |
Who may qualify
- Ages
- 0 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- At sites in the US: Male or female up to and including 75 years of age (including all pediatric age groups). At sites in the Europe: Male or female between 18 and 70 years of age, inclusive.
- Diagnosed with active non-infectious anterior uveitis with anterior chamber cell Grade 2 (6-15 cells) or Grade 3 (16-30 cells) in the study eye that are without any treatment or with Stable Medical Therapy requiring further treatment.
- Have Best Corrected Visual Acuity (BCVA) vision ≥ 65 letters in the non-study eye using Early Treatment Diabetic Retinopathy Study (ETDRS).
Key exclusion criteria (7 listed)
- Pregnant or breastfeeding females or females.
- History of or active significant ocular disease in either eye.
- Uncontrolled intraocular pressure (IOP; defined as >27mmHg) or narrow angle glaucoma in either eye and/or are at risk of angle closure with dilating.
- Poor posterior view due to limitation of dilation or media opacity that limits ability to examine the posterior segment.
- Cancer or melanoma that is actively treated with immunotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRS01TRS01 eye drops Dosed four times a day (QID) | Drug | TRS01 |
| FDA approved steroid eye drop (masked)FDA approved steroid eye drop Dosed four times a day (QID) | Drug | Active comparator |
Primary outcome
Anterior Chamber Cell (ACC) Grade = 0 on Day 28
Time frame: 28 days
For FDA submission: the percentage of subjects with Anterior Chamber Cell (ACC) Grade=0 (0 cells) on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells).
Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 28
Time frame: 28 days
For submission to European Medicines Agency (EMA) related countries: the percentage of subjects with ACC Grade = 0 or 1 on Day 28 in the study eye. ACC=0 is complete resolution of inflammation (0 cells), ACC=1 represent trace cells.
4 secondary outcomes
Change From Baseline (Day 1) in ACC Grade on Day 28 in the Study Eye
Time frame: 28 days
Anterior Chamber Cell (ACC) Grade on Day 21
Time frame: 21 days
Change From Baseline in ACC Grade on Day 21.
Time frame: 21 days
Anterior Chamber Cell (ACC) Grade = 0 or 1 on Day 21
Time frame: 21 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 41485727Chu DS, Tsui E, Rifkin LM, Palestine AG, Rich C, Thorne JE, Haim-Langford D, Milman Z, Fulcher E, Neumann R, DE Smet MD; TRS4Vision Study Group. Dazdotuftide: Novel Treatment for Noninfectious Uveitis with Superior Intraocular Pressure Safety Profile: A Randomized Clinical Trial. Am J Ophthalmol. 2026 Apr;284:78-87. doi: 10.1016/j.ajo.2025.12.034. Epub 2026 Jan 2.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lexitas Clinical Trials study director
Lexitas
30 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TRS01 and FDA approved steroid eye drop (masked) in people with Non-infectious Anterior Uveitis and Uveitic Glaucoma, run by Tarsier Pharma at 30 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Germany, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anterior Chamber Cell (ACC) Grade = 0 on Day 28 (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05042609, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.