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| ID | Type | Description | Link |
|---|---|---|---|
| IRB00000533 | Other Identifier | WCG IRB |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intense Pulsed Light treated arm | Experimental | The treatment consists in Intense Pulsed Light C.STIM® with recommended fluence. |
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| Very low fluence Intense Pulsed Light arm (placebo) | Placebo Comparator | The treatment consists in Intense Pulsed Light C.STIM® with a very low fluence. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intense pulsed light with C.STIM device | Device | 4 flashes per treatment session |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 60 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Visionary Consultants Inc. | Lexington | Kentucky | 40517 | United States | ||
| Triangle Eye Consultants |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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MULTI-CENTER, PROSPECTIVE, RANDOMIZED, SHAM-CONTROLLED, SUPERIORITY, NON-SIGNIFICANT RISK
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| 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) | 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 | 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 | 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. | 60 days |
| Use of artificial tear drops | Change in use of artificial tear drops frequency before treatment and after treatment | 60 days |
| Use of artificial tear drops | Change in use of artificial tear drops quantity before treatment and after treatment | 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) | 60 days |
| Raleigh |
| North Carolina |
| 27617 |
| United States |
| Toyos Clinic | Nashville | Tennessee | 37215 | United States |
| Eye Centers of Racine & Kenosha | Kenosha | Wisconsin | 53142 | United States |