Clinical trials on treatment of meibomian gland dysfunction lacking

FORT LAUDERDALE, Fla. — Efforts are under way to establish design standards for clinical trials on diagnosis and treatment of meibomian gland dysfunction, a speaker said at the Association for Research in Vision and Ophthalmology meeting here.

"We want randomized, controlled trials. We'd like them to be masked. We have not seen a great deal of evidence to date," Penny A. Asbell, MD, FACS, MBA, said during a preliminary report of the International Workshop on Meibomian Gland Dysfunction.

"We need information on the natural history of meibomian dysfunction," Dr. Asbell said. "We really haven't totally determined the relationship between [meibomian gland dysfunction] and dry eye disease. ... Clearly for treatment, understanding and eventually for our patient care, we'll be thinking about a clinical trial."

Dr. Asbell and fellow workshop members scanned existing literature for information that would shed light on clinical trial design.

An intense peer-review search of meibomian gland dysfunction studies yielded only 16 reports with proper clinical trial methodology, Dr. Asbell said. Only three of the studies were randomized clinical trials; most had small patient groups and lacked statistical power.

"The level of evidence often is not what we would like," she said.

A clinical trial for meibomian gland dysfunction would need specific inclusion and exclusion criteria, a definition of the quality of meibomian gland secretions, well-defined endpoints, treatment protocols, adequate sample size, identification of relevant biomarkers and minimal bias, Dr. Asbell said.

Genetic, systemic, environmental and cultural risk factors for meibomian gland dysfunction should also be examined.

Epidemiologic studies have yielded an understanding of the number of patients affected and risk factors for meibomian gland dysfunction, she said.