Clinical Research: On the Edge of Innovation

COMET-3 Clinical Trial: Part 1

COMET-3 clinical trial (Dry Eye) is a clinical trial VEI is currently involved in. Dr. Malouf is the principle investigator in this trial and Dr. Estopinal is a sub-investigator. VEI has partnered with Ora, Inc. a Clinical Research Organization specializing in ophthalmic clinical research. Ora supports clinical trials dealing with ocular surface, anterior segment, posterior segment, and ophthalmic devices.

The COMET-3 trial focuses on dry eye and and an investigational product (IP), an eye drop looking to offer possible cooling relief for patients with dry eye. The trial consists of 6 clinical visits over a period of 15 weeks. This past weekend we just finished visit #5 and the last visit is scheduled for January 2023.

These dry eye trials are held on the weekends for several reasons:

• Block Enrollment: Over the course of 2-4 days we schedule as many patients as we can.
Our first group we had 76 patients scheduled over 2 days (Saturday / Sunday)
This is a lot of patients, and a lot of time, to work into a doctors weekly schedule.

• Controlled Adverse Environment (CAE):
Ora has a number of different vehicles outfitted to control the relative humidity, temperature, airflow, and visual tasking. The CAE’s range from a van to a semi-truck.

Our group of 76 scheduled patients in 2 days required the semi-truck. There were 2 semi’s delivered late on Friday night and set up. One semi held 2 separate testing rooms with 4 seats each. This allowed us to test 8 people at a time. The second semi truck contained all the necessary HVAC systems and power systems to control the humidity, temperature, airflow and power. As you can see in the pictures below there were a number of parking spots that were utilized to park both semi’s. Another reason we are utilizing our weekends for clinical trials.

The moment our last patient finished in the CAE on Sunday, the semi-trucks rolled in to break down their equipment and haul the trailers out so we would be ready for our normal clinic day first thing Monday morning.

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