A Prospective Clinical Study Assessing the Effects of Tetracycline Antibiotic on Tear Film and Tear Lipid Composition Within a Population of Patients Diagnosed With Blepharitis and Dry Eye Disease

Tear film dysfunctions, which are collectively diagnosed as dry eye syndromes and Meibomian Gland Dystrophy (MGD) afflict millions of individuals worldwide, more than 10 million in the United States alone. Typically, symptoms include ocular burning, foreign body sensation, photophobia, redness and other symptoms that result in overall chronic discomfort in patients. Tetracycline analogues, such as minocycline, have demonstrated effectiveness in treating primary meibomianitis, one type of chronic blepharitis and have been prescribed to patients for sometime. It has been demonstrated that tetracycline can inhibit lipase activity and therefore decrease the release of noxious free fatty acids. Tetracycline also inhibits bacterial lipase activity in vitro and has other effects. We have been investigating the associations between chronic blepharitis and eyelid meibomian gland lipids and microflora for a number of years and have discovered important relationships between these lipids and chronic blepharitis disease states. Because of its high concentration 12 hours post dose, low renal clearance, long half life, and high level of binding to serum proteins, minocycline has been suggested as a good treatment option. The study proposes to determine the effect of oral treatment with tetracycline analogues on the Tear Film and Tear Lipid Composition within a Population of Patients Diagnosed with Dry Eye Disease and Meibomian Gland Dysfunction.

Patients diagnosed with dry eye syndrome as well as Meibomian Gland Dystrophy (MGD) will be selected to participate in a clinical study: baseline visit, 1-month following initiation of treatment, 3-months after initiation of treatment, and 3-months after discontinuation of treatment.

Once assessed and qualified to take part in the trial, participants will undergo the following tests during each visit:

I. Ocular assessment of signs and symptoms II. Evaporometry III. Fluorophotometery IV. Schirmers Testing V. TBUT VI. Bacteriology VII. Transillumination & Meibography VIII. Meibomian gland expression and lipid analysis

After completion of the baseline visit, each patient will be given a 2-week regimen of 50-mg dose of Minocycline followed by 10-week supply of 100-mg Minocycline to be taken daily after breakfast. In addition, they can continue using artificial tears and additional treatments as prescribed by their treating physicians.