Dry Eye Clinical Studies

MORRISVILLE, N.C. ─ September 8, 2015 ─ TearScience, a privately held medical device company, announces the results of a major review demonstrating that a single LipiFlow®procedure can significantly improve meibomian gland function and relieve symptoms associated with Meibomian Gland Disease (MGD) with efficacy reported for 12 months and longer. The review by researchers from Korb Associates in Boston, Massachusetts, and the Duke Eye Center, Durham, North Carolina, noted that “A single vectored thermal pulsation treatment allows for reducing dry eye symptoms, improving meibomian gland function and other correlates of the ocular surface health.” To date, more than 79,000 LipiFlow procedures have been performed.

MGD is an obstructive disease that is prevalent, progressive and a major cause of Dry Eye Disease (DED); in some studies, MGD is the primary cause in as many as 86% of DED cases. Thus, safe and effective removal of obstruction remains the core therapeutic procedure in MGD management prior to the inclusion of various adjunctive therapies. !!!!

“This review validates the important and fundamental role of LipiFlow in the management of MGD, a prevalent and under-reported disease, and primary contributor to the discomfort and fluctuating vision that accompanies Dry Eye. Notably, it is one of the leading motivations for many patients seeking an eye care provider,” said Alan Carlson, MD, Vice Chair, Development at Duke Eye Center, Durham North Carolina.

Blackie and colleagues looked at data from 23 meeting presentations and 8 peer-reviewed published studies on effects of the vectored thermal pulsation procedure on MGD. According to the report of sponsored and independent studies, 30 of the 31 studies showed a mean improvement in symptom score following a single treatment. All of the studies demonstrated that the LipiFlow treatment was effective in improving meibomian gland function, on average.

Two long-term controlled studies demonstrated mean reduction of dry eye symptoms and mean improvement in gland function for 6 and 12 months, respectively, for patients who received a single LipiFlow procedure.    “In both cases [sic], the single 12-min vectored thermal pulsation procedure performed better than the twice-daily ‘standard-of-care’ approach,” (ie Hot Compresses)  the study authors wrote. Blackie and colleagues cautioned that while results of the one uncontrolled long-term study “remain somewhat speculative,” that case series showed lasting mean improvement in meibomian gland function for up to 4 years following treatment.

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Br J Ophthalmol. 2015 Feb;99(2):199-204. doi: 10.1136/bjophthalmol-2014-305410. Epub 2014 Aug 19.

Oral azithromycin versus doxycycline in meibomian gland dysfunction: a randomised double-masked open-label clinical trial.

Abstract

BACKGROUND/AIMS:

To assess the efficacy and safety of oral azithromycin compared with oral doxycycline in patients with meibomian gland dysfunction (MGD) who had failed to respond to prior conservative management.

METHODS:

110 patients (>12 years old) with MGD were randomly assigned to receive either oral 5-day azithromycin (500 mg on day 1 and then 250 mg/day) or 1-month doxycycline (200 mg/day). They also continued eyelid warming/cleaning and artificial tears. A score comprising five symptoms and seven signs (primary outcome) was recorded prior to treatment and at 1 week, and 1 and 2 months after treatment. Total score was the sum of both scores at each follow-up. Side effects were recorded and overall clinical improvement was categorised as excellent, good, fair or poor based on the percentage of change in the total score.

RESULTS:

Symptoms and signs improved significantly in both groups (p=0.001). While improvement of symptoms was not different between the groups, bulbar conjunctival redness (p=0.004) and ocular surface staining (p=0.01) were significantly better in the azithromycin group. The azithromycin group showed a significantly better overall clinical response (p=0.01). Mild gastrointestinal side effects were not significantly different between the groups except for the second visit, when the doxycycline group had significantly more side effects (p=0.002).

CONCLUSIONS:

Although both oral azithromycin and doxycycline improved the symptoms of MGD, 5-day oral azithromycin is recommended for its better effect on improving the signs, better overall clinical response and shorter duration of treatment.