Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01190397
Other study ID # LT2420-PI-CE-07/10
Secondary ID
Status Completed
Phase Phase 1
First received August 25, 2010
Last updated December 3, 2010
Start date September 2010
Est. completion date November 2010

Study information

Verified date December 2010
Source Laboratoires Thea
Contact n/a
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date November 2010
Est. primary completion date November 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 4 Years and older
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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Warming goggles

warm and moist compresses


Locations

Country Name City State
United Kingdom School of Optometry & Vision Sciences Cardiff

Sponsors (1)

Lead Sponsor Collaborator
Laboratoires Thea

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Temperature measurements The temperature in the chamber of the goggles for Blephasteam device, or between the lid and the compresses for the moist and warm compress, will be evaluated in 10 consecutive measurements over a period of 10 minutes with a micro sensor at the lower lid margin of one randomly selected eye of 10 randomly selected subjects No
Secondary Humidity measurements The humidity in the chamber of the goggles for Blephasteam device, or between the lid and the compresses for the moist and warm compress, will be evaluated in 10 consecutive measurements over a period of 10 minutes with a micro sensor at the lower lid margin of one randomly selected eye of 10 randomly selected subjects. No
See also
  Status Clinical Trial Phase
Withdrawn NCT05672407 - The Role of Local Tranexamic Acid on Periorbital Oculoplastic Surgery Phase 4
Completed NCT03199911 - Topical Antibiotic Prophylaxis for Eyelids Phase 4
Recruiting NCT04689230 - Small Incision Technique Versus Upper Blepharoplasty in Upper Eyelid Medial Pad Fat Removal N/A
Completed NCT01091311 - Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases Phase 4
Recruiting NCT04359979 - Tamsulosin for Thyroid Lid Retraction N/A
Recruiting NCT04102878 - Transconjunctival vs Transcutaneous Anaesthesia in Oculoplastics N/A
Completed NCT01189474 - Evaluation of Satisfaction Regarding Patient's Management of Ocular Surface Diseases Phase 4
Active, not recruiting NCT04149210 - FLuorometholone as Adjunctive MEdical Therapy for TT Surgery (FLAME) Trial Phase 3
Not yet recruiting NCT04235803 - Telemedicine Follow-up for Routine, Low-Risk Oculoplastic Surgery N/A
Completed NCT04554329 - Bandage Contact Lenses Versus Eye Patching of Müller's Muscle-conjunctival Resection N/A
Recruiting NCT04898933 - Patient Satisfaction After Eyelid Lesion Excision
Recruiting NCT04861454 - Brassiere Brow Suture and Internal Browpexy
Recruiting NCT04201925 - Functional Changes After Upper Blepharoplasty
Recruiting NCT04255667 - Eyelid Crush for Marginal Eyelid Surgery
Recruiting NCT05750251 - Effect of Upper Eyelid Surgeries on Corneal Characteristics
Recruiting NCT05016362 - Medial Fat Pad Preservation in Upper Eyelid Blepharoplasty
Recruiting NCT05945069 - Feasibility of Dynamic Muscle Stimulation + Radiofrequency for Improving Blink Quality in Subjects With Dry Eye Disease N/A
Recruiting NCT04140734 - Spacer Graft Study N/A
Recruiting NCT04720586 - Surgical Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis N/A
Recruiting NCT04921020 - Assessment of Eyelid Topology and Kinetics Based on Deep Learning Method