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OpenTrials
Completed

NCT Number: NCT04222725

A Study of TRS01 in Participants With Post-surgical Ocular 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.

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Key information

Conditions

Post Surgical Ocular Inflammation Inflammation Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Inglewood, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TRS01 eye drops

Drug

Dosed 4 times a day (QID)

Placebo Eye Drops

Drug

Dosed QID

Primary outcomes

  1. Assessment of Both Systemic and Ocular Adverse Events

    Time frame: 14 days

    Number of adverse events that occurred during the study

Sponsors and collaborators

Lead sponsor

Tarsier Pharma

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 10, 2020
Registry last updated
Oct 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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