Post Surgical Ocular InflammationPhase 1/2NCT04222725
A Study of TRS01 in Participants With Post-surgical Ocular Inflammation
A Phase 1/2 study testing TRS01 eye drops in people with Post Surgical Ocular Inflammation, run by Tarsier Pharma at 5 sites in United States.
Trial summary
The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Surgical Ocular Inflammation
- What is being tested?
- TRS01 eye drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 5 sitesUnited States
- Study dates
- 1 Feb 2020to 17 Jul 2020
- Phase
- Phase 1/2
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are:
- 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.
- Scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (IOL) implantation, and not combined with any other surgery.
- Have vision ≥ 20/200 in the non-study eye.
- Able to self-administer eye drops (tested during screening by self-administration of "artificial tears"), or have a care provider that can administer the drops.
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- Have no known sensitivity /allergy to the TRS01 or formulation excipients.
- Using adequate birth control by men and women, if of reproductive potential and sexually active, as specified per protocol
- Randomization inclusion criteria as specified per protocol.
Who cannot join
- Scheduled to undergo cataract surgery in the non-study eye for the duration of the study.
- Receiving specific medication/interventions as specified per protocol
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Cincinnati
Cincinnati, Ohio, 45242
Inglewood
Inglewood, California, 90302
New York
New York, New York, 10013
Petaluma
Petaluma, California, 94954
Washington, MO
Washington, Missouri, 63090
About this study
Official title: A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation
The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.
- Conditions
- Post Surgical Ocular Inflammation
- Being tested
- TRS01 eye drops, Placebo eye drops
- Keywords
- postoperative, postsurgical, ocular, inflammation, pain
- Medical subject headings
- Inflammation, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRS01 eye dropsDrug
Dosed 4 times a day (QID)
TRS01 eye dropsDrug
Dosed QID
TRS01 eye dropsDrug
Dosed QID
Placebo eye dropsDrug
Dosed QID
| Study group | Role | What they receive |
|---|---|---|
| TRS01 low dose | Experimental | Not described Receives: Drug: TRS01 eye drops |
| TRS01 medium dose | Experimental | Not described Receives: Drug: TRS01 eye drops |
| TRS01 high dose | Experimental | Not described Receives: Drug: TRS01 eye drops |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Both Systemic and Ocular Adverse Events
Number of adverse events that occurred during the study
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2020
- Study start1 Feb 2020
- Primary completion17 Jul 2020
- Study completion17 Jul 2020
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.
- Other trials for Post Surgical Ocular InflammationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tarsier Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04222725
- Sponsor's protocol ID
- Tarsius 2020
- Other IDs
- 2019-004327-20, Grant Agreement Number 879598, 2019
- Status last verified
- Jan 2020
- First submitted
- 7 Jan 2020
- Last updated
- 14 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Double-Masked, Randomized, Vehicle-controlled, Dose-ranging Study to Evaluate the Safety of TRS01 Eye Drops in Participants With Post-surgical Inflammation
- ClinicalTrials.gov ID
- NCT04222725
- Acronym / sponsor ID
- Tarsius 2020
- Conditions
- Post Surgical Ocular Inflammation
- Keywords
- postoperative, postsurgical, ocular, inflammation, pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Tarsier PharmaIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 17 Jul 2020 (actual)
- Study completion
- 17 Jul 2020 (actual)
- First posted
- 10 Jan 2020 (actual)
- Results
- Posted 14 Oct 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to evaluate the safety and preliminary efficacy of TRS01 eye drops as compared to placebo on participants with ocular inflammation after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| TRS01 low dose | Experimental | Drug: TRS01 eye drops |
| TRS01 medium dose | Experimental | Drug: TRS01 eye drops |
| TRS01 high dose | Experimental | Drug: TRS01 eye drops |
| Placebo | Placebo comparator | Drug: Placebo eye drops |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Pre-operatively, individuals of either gender or any race will be eligible for study participation if they are:
- 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.
- Scheduled for routine cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens (IOL) implantation, and not combined with any other surgery.
- Have vision ≥ 20/200 in the non-study eye.
Key exclusion criteria (2 listed)
- Scheduled to undergo cataract surgery in the non-study eye for the duration of the study.
- Receiving specific medication/interventions as specified per protocol
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 |
|---|---|---|
| TRS01 eye dropsDosed 4 times a day (QID) | Drug | TRS01 low dose |
| TRS01 eye dropsDosed QID | Drug | TRS01 medium dose |
| TRS01 eye dropsDosed QID | Drug | TRS01 high dose |
| Placebo eye dropsDosed QID | Drug | Placebo |
Primary outcome
Assessment of Both Systemic and Ocular Adverse Events
Time frame: 14 days
Number of adverse events that occurred during the study
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Post Surgical Ocular Inflammation
Enrolling by invitationPhase 3
A Phase 3 Study Evaluating the Safety and Efficacy of TRIESENCE® (Injectable Suspension) for the Treatment of Ocular Inflammation and Pain After Ophthalmic Surgery
Postoperative Ocular Inflammation, Postoperative Ocular Pain
RecruitingPhase 4
Dextenza in the Post-op Management of Vitreoretinal Surgeries
Vitreoretinal Surgery, Ocular Inflammation
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing TRS01 eye drops in people with Post Surgical Ocular Inflammation, run by Tarsier Pharma at 5 sites in United States.
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 9 inclusion and 2 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 14 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 14 Oct 2021). 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?
Assessment of Both Systemic and Ocular Adverse Events (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2021.