Eyelid Diseases Clinical Trial
Official title:
Clinical Safety Study on an Eyelid Warming Device, Moist Heat Technology BLEPHASTEAM®, to Evaluate the Eyelid and Cornea Temperature in Healthy Volunteers
| NCT number | NCT01086943 |
| Other study ID # | LT2420-PI-CE-07/07 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 1 |
| First received | March 12, 2010 |
| Last updated | January 27, 2012 |
| Verified date | January 2012 |
| Source | Laboratoires Thea |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Ethics Committee |
| Study type | Interventional |
The eyelid warming device is designed to relieve the symptoms of dysfunction of the glands
in the eyelids.
Prospective, non comparative, open, monocentre study.
The objectives are:
- To verify and establish the temperature of the eyelids and cornea for each eye before
and after 10 minutes device application
- To evaluate the ocular surface, NIBUT and IOP before and after device application
- To determine the acceptability of healthy volunteers on the practical use of this
device
The subjects will attend 2 visits.
| Status | Completed |
| Enrollment | 25 |
| Est. completion date | |
| Est. primary completion date | |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
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. |
Intervention Model: Single Group Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | School of Optometry & Vision Sciences | Cardiff |
| Lead Sponsor | Collaborator |
|---|---|
| Laboratoires Thea |
United Kingdom,
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