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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
101
4 flashes per treatment session
Visionary Consultants Inc.
Lexington, Kentucky, United States
Triangle Eye Consultants
Raleigh, North Carolina, United States
Toyos Clinic
Nashville, Tennessee, United States
Eye Centers of Racine & Kenosha
Kenosha, Wisconsin, United States
Tear Break-Up Time evolution
Difference of the evolution of Tear Break-Up time (TBUT) between the 2 arms of the study (placebo and treated).
Time frame: 60 days
dry eye signs and symptoms
Evolution of dry eye signs and symptoms: DEQ5, Dry Eye Questionnaire 5, score varies from 0 (normal) to 22 (severe symptoms).
Time frame: 60 days
dry eye signs and symptoms
Evolution of dry eye signs and symptoms: NIBUT, Non Invasive Break Up Time, normal if higher than 10 second.
Time frame: 60 days
dry eye signs and symptoms
Evolution of dry eye signs and symptoms: OSDI, the Ocular Surface Disease Index is a questionnaire with score from 0 (normal) to 100 (severe dry eye symptoms)
Time frame: 60 days
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Assessment of device safety and tolerability (ocular and dermatologic aspect) : comparison of number of adverse event occurence between the two arms
Time frame: 60 days
Meibum quality
Quality of meibum evaluation by Meibomian gland secretion assessment using Meibum Quality : : is assessed in each of 8 glands of the central third of the lower lid on a 0-3 scale for each gland: 0=clear meibum / 1=cloudy meibum/ 2=cloudy with debris (granular)/3=thick, like toothpaste
Time frame: 60 days
Meibum Expressibility
Quality of meibum evaluation by Meibomian gland secretion assessment using Meibum Expressibility : Expressibility of meibum is assessed from 5 glands: 0= all glands expressible / 1=3-4 glands expressible/ 2= 1-2 glands expressible./ 3=no glands expressible.
Time frame: 60 days
Use of artificial tear drops
Change in use of artificial tear drops frequency before treatment and after treatment
Time frame: 60 days
Use of artificial tear drops
Change in use of artificial tear drops quantity before treatment and after treatment
Time frame: 60 days
Glaucoma
Observation of the difference in evolution of dry eye disease in glaucoma vs non-glaucoma patients : comparaison of the Tear Break Up Time in second (normal if superior to 10 seconds)
Time frame: 60 days
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