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Methods for treating ocular rosacea

a technology for ocular rosacea and ocular irritation, which is applied in the direction of drug compositions, aerosol delivery, extracellular fluid disorder, etc., can solve the problems of meibomian gland atrophy, long time-consuming treatment, and potential sight-threatening problems, so as to reduce ocular irritation, delay the effect of tear clearance and relief of symptoms

Inactive Publication Date: 2006-07-13
PFLUGFELDER STEPHEN C +2
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0007] The subject invention concerns a class of agents and methods of using those agents for treatment of a patient having meibomian gland disease, including relief of symptoms or conditions associated with the disease, such as ocular irritation, delayed tear clearance, or recurrent corneal epithelial erosion. More specifically, the subject invention concerns agents and methods for decreasing ocular irritation, and surface inflammation, improving tear clearance, reducing tear IL-1α concentration, or inhibiting IL-1α-mediated matrix metalloproteinase activity which is increased in patients with meibomian gland disease or delayed tear clearance. The subject invention can thus be useful for reducing eye irritation, improving tear clearance, reducing IL-1α concentration in the tear fluid, or inhibiting MMP activity in the tear fluid of patients with delayed tear clearance and increased tear fluid IL-1α.

Problems solved by technology

It has been reported that 15% of patients with ocular rosacea develop recurrent corneal epithelial erosions, a potentially sight-threatening problem.
Although patients with this condition usually have normal production of aqueous tears by their lacrimal glands, their meibomian glands can atrophy and this is frequently accompanied by metaplasia of the ductal epithelium of these glands.
Therefore, previous treatments of meibomian gland disease were directed only to treatment of presumed infection of the eyelids or meibomian glands, or had particular disadvantages that made such treatments of little use for long periods of time.
For example, patients with meibomian gland disease have been symptomatically treated with artificial tears, but these agents provide limited, if any, improvement.
However, steroids are not good long-term solutions because of the potential side-effects e.g., cataract and glaucoma.
Meibomian gland disease is currently not curable or reversible; therefore, patients with this condition must be treated for life.
However, one disadvantage for using antimicrobially active tetracyclines or tetracycline analogues orally in the treatment of meibomian gland disease is that a high percentage of patients are unable to tolerate oral tetracyclines for extended periods of time.
The intolerance to tetracyclines can manifest itself in gastrointestinal problems, e.g., epigastric pain, nausea, vomiting, and diarrhea, or other problems related to taking long-term oral antibiotics, such as mucosal candidiasis.
At the present time there are no available long-term treatments of meibomian gland disease.

Method used

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  • Methods for treating ocular rosacea
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  • Methods for treating ocular rosacea

Examples

Experimental program
Comparison scheme
Effect test

example 1

Identification of Increased IL-1α Concentrations in Meibomian Gland Disease Patients

[0034] In one study, tear fluid concentrations of Interleukin-1-alpha (IL-1α), Tumor Necrosis Factor-α (TNF-α), and Epidermal Growth Factor (EGF) in patients having ocular rosacea were compared with those concentrations in normal patients (controls).

[0035] Fourteen (14) patients with severe meibomian gland disease, facial rosacea, and symptoms of ocular irritation were examined for ocular surface disease, tear production and tear clearance rate (TCR). For meibomian gland disease assessment, meibomian glands were examined by slit lamp biomicroscopy and graded for the presence of orifice metaplasia, expressibility of meibum, and meibomian gland acinar dropout, as previously described and known from the scientific literature. Twelve (12) controls, frequency-matched for age, and fifteen (15) ideal normals were assessed using the same parameters.

[0036] Minimally stimulated tear samples (20 μl) were dra...

example 2

Correlation of Gelatinise Activity with IL-1α Concentration and Tear Clearance

[0041] Tear fluorescein clearance was correlated with IL-1α concentration and 92 kD gelatinase (MMP 9) activity in the tears of patients. Thirteen patients with ocular rosacea (including 1 patient with recurrent epithelial erosion, 2 with recurrent peripheral corneal infiltrates and vascularization and 2 patients with epithelial basement membrane dystrophy) and 13 normal subjects with normal aqueous tear production and no irritation symptoms were evaluated. Tear fluorescein clearance was evaluated by measuring fluorescence in tear fluid collected from the inferior meniscus 15 minutes after instillation of 5 ml of 2% Na-fluorescein with a Cytofluor II. IL-1α was measured by ELISA using an R&D Systems kit. Gelatinase activity was evaluated by gelatin zymography, comparing tear activity to purified 92 kD gelatinase (MMP 9).

[0042] Compared to normal controls, patients with ocular rosacea had greater delay of...

example 3

Reduced Tear Clearance in Ocular Irritation

[0043] Reduced tear clearance is commonly found in most patients with ocular irritation irrespective of the patient's tear production. Forty (40) abnormal patients presenting with a chief complaint of ocular irritation and forty (40) asymptomatic controls of similar age distribution were used to correlate and compare a new method of measuring tear fluorescein clearance and the Schirmer 1 test with the severity of ocular irritation symptoms, presence of meibomian gland disease, corneal fluorescein staining scores, and corneal and conjunctival sensitivity. All subjects completed a symptom questionnaire, a baseline ocular examination, fluorescein clearance test (FCT) and Schirmer test.

[0044] Methods. The fluorescein clearance test (FCT) was performed by measuring the fluorescein concentration in minimally-stimulated tear samples collected from the inferior tear meniscus 15 minutes after instillation of 5 μl of 2% sodium fluorescein with a Cy...

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Abstract

A method for treating a patient having meibomian gland disease, ocular irritation associated with delayed tear clearance, or recurrent corneal epithelial erosion, is disclosed. Preferably, the method concerns treatment of a patient with topical tetracycline, a derivative or analogue of tetracycline, or a chemically modified tetracycline (CMT). Oral administration of a CMT is also disclosed as part of the method for treating meibomian gland disease, ocular irritation associated with delayed tear clearance, or recurrent corneal epithelial erosion.

Description

BACKGROUND OF THE INVENTION [0001] Meibomian gland disease is the most common tear film and ocular surface disorder causing eye irritation. The incidence of the disease increases with age, and occurs in approximately 50% of patients with the skin disease, rosacea. A conservative estimate of the number of patients affected with this condition is 10 million in the United States alone. It has been reported that 15% of patients with ocular rosacea develop recurrent corneal epithelial erosions, a potentially sight-threatening problem. [0002] Common complaints of patients suffering from meibomian gland disease include blurred or filmy vision, burning or foreign body sensations in the eye, photophobia, and pain severe enough to awaken the person from sleep. Although patients with this condition usually have normal production of aqueous tears by their lacrimal glands, their meibomian glands can atrophy and this is frequently accompanied by metaplasia of the ductal epithelium of these glands...

Claims

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Application Information

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IPC IPC(8): A61K31/65A61K9/06A61P27/02
CPCY10S514/912A61K31/65A61P27/00A61P27/02A61P31/00A61P33/00A61P7/02
Inventor PFLUGFELDER, STEPHEN C.LOKESHWAR, BALAKRISHNA L.SELZER, MARIE
Owner PFLUGFELDER STEPHEN C
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