NCT06349356

Prospective Evaluation of Efficacy and Safety of an Intense Pulsed Light Device to Treat Dry Eye Disease"

" Prospective Evaluation of Efficacy and Safety of C.STIM® , an Intense Pulsed Light Device to Treat Signs and Symptoms of Dry Eye Disease (DED)"

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: Quantel Medical · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to evaluate the efficacy and safety of C.STIM, an intense pulsed light device to treat signs and symptoms of dry eye disease. The main question it aims to answer is: • Difference of the evolution of Tear Break-Up time (TBUT) between the 2 arms of the study (placebo and treated). Researchers will compare treated group and placebo to respond to the main question. Participants will assess to an inclusion visit (disease evaluation purpose) and then four IPL treatment visit to finish with the last visit (disease evaluation purpose).

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DEVICE	Intense pulsed light with C.STIM device	4 flashes per treatment session

Timeline

• Start date: 2023-03-28
• Primary completion: 2024-07-11
• Completion: 2024-07-11
• First posted: 2024-04-05
• Last updated: 2024-12-10

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study