Post Surgical Ocular Inflammation Clinical Trial
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
| Verified date | January 2020 |
| Source | Tarsier Pharma |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 37 |
| Est. completion date | July 17, 2020 |
| Est. primary completion date | July 17, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | Inclusion Criteria: 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. - 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. Exclusion Criteria: - Scheduled to undergo cataract surgery in the non-study eye for the duration of the study. - Receiving specific medication/interventions as specified per protocol |
| Country | Name | City | State |
|---|---|---|---|
| United States | Cincinnati | Cincinnati | Ohio |
| United States | Inglewood | Inglewood | California |
| United States | New York | New York | New York |
| United States | Petaluma | Petaluma | California |
| United States | Washington, MO | Washington | Missouri |
| Lead Sponsor | Collaborator |
|---|---|
| Tarsier Pharma |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Assessment of Both Systemic and Ocular Adverse Events | Number of adverse events that occurred during the study | 14 days |