Warming Efficiency of Warm Compresses Versus BLEPHASTEAM® in Eyelid Therapy

Thea Pharma

Status and phase: Completed; Phase 1

Conditions: Eyelid Diseases

Treatments: Device: Warming goggles; Device: warm and moist compresses

Study type: Interventional

Funder types: Industry

Identifiers

NCT01190397

LT2420-PI-CE-07/10

Details and patient eligibility

About

The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands in the eyelids

Phase I, prospective, comparative study, investigator masked , monocentric

Objectives are To assess and compare the warming and moisture of Blephasteam® device versus the warming and moisture of warm and moist compresses.

To assess and compare safety on the ocular surface after 10 minutes of Blephasteam® application versus after 10 minutes of warm and moist compresses application

Enrollment: 20 estimated patients

Sex: All

Ages: 4+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

• Male or female aged from 18 to 80 years old.
• Healthy volunteers.
• For any contact lens wearers, they must be wearing hydrogel contact lenses (worn at least 3 times per week)
• Normal ocular examination in both eyes.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

20 participants in 2 patient groups

Blephasteam Arm

Experimental group

Treatment:

Device: Warming goggles

warm and moist compresses arm

Active Comparator group

Treatment:

Device: warm and moist compresses