Eyelid Warming Technology for Meibomian Gland Dysfunction

Study Objectives and Purpose:

• A primary purpose of the study is to compare the efficacy of novel eyelid warming devices (Blephasteam and EyeGiene) for treatment of meibomian gland dysfunction by objective clinical scoring and objective assessment of ocular surface parameters in an Asian population.
• The second aim is to assess the patient acceptance of these modalities, in terms of comfort and convenience.
• A third aim of the study is to document Meibomian gland disease using non-invasive Meibography, and the possible alterations of this condition after treatment.

Study Design: Prospective, controlled, single masked, interventional study

Rationale:

Meibomian gland dysfunction and resulting evaporative dry eye is highly common in our general population. Behavioral factors and environmental stress may contribute to the severity of the disease. Eyelid warming devices have the potential to significantly improve meibomian gland health and alleviate dry eye symptoms associated with the disease. Currently eyelid warming devices suitable for treatment of meibomian gland dysfunction are not available in Singapore.

Recent technological advances, as well as the infrastructure of the Singapore Eye Research Institute (proximity to Singapore National Eye Center and pre-existing facility and infrastructure for clinical trials) have facilitated studies of products that are available elsewhere and may benefit the Singaporean population.

Methods:

Participants and target sample size Seventy-five patients from the dry eye clinic in the Singapore National Eye Center who have obstructive meibomian gland dysfunction and are keen to test alternative ways for treating the disease will be selected.

Randomisation is done by randomisation table as deemed appropriate by the statistician collaborator.

Treatment regime After informed written consent, patients will be randomly assigned to a group.

• Control group, 10-minute treatment, twice daily
• Blephasteam, 10-minute treatment, twice daily
• EyeGiene, 10-minute treatment, twice daily

All patients are permitted to continue their regular management of MGD such as use of lid scrubs or lid hygiene preparations (such as Lidcare and Blephagel). For consistency, the investigators will monitor the use of such measures in a daily diary and prohibit any other types of treatment for MGD such as Omega-3 tablets, antibiotic or steroid ointments, probing of MG.

Visit schedules Screening visit will be performed at the regular dry eye clinic. If eligible, patients will sign consent and undergo baseline examination.

Subsequent to this, the follow up visit will be after 4 weeks of treatment. A window period of

+/-3days is permitted for this visit.

Duration of study:

Four weeks.

Inclusion criteria

• Eyelids must present with blocked meibomian gland openings (plugs), at least 1 visible MG plug in the 4 eyelids, or discernable change in consistency of meibum when MG expressed in upper or lower eyelids.
• At least one out of 8 questions on dry eye symptoms is answered with often or all the time (Appendix C, Questionnaire modified after Schein et al.,1997).
• Eyes should not show any other ocular surface pathology which required more treatment than eye lubricant and conventional eyelid hygiene.

Exclusion criteria

• Known history of thyroid disorders (diagnosed by physician).
• No ocular surgery within the previous 6 months and LASIK within the previous 1 year.
• Any intake of central nervous system and hormonal drugs within last 30 days and inability to withhold such drugs for at least 6 weeks.
• Active ocular infection or pterygium.
• Anticipated necessity to wear contact lens in the duration of the study.
• Living in the same household as another participant of the study.
• Any other specified reason as determined by clinical investigator, for example, the need to use any treatment or eyedrops (eg. Restasis) not permitted by the study.