The aim of this study was to assess the efficacy of using a combination treatment approach consisting of lipid emulsion eye drops, eyelid cleansing wipes, and omega-3 vitamin supplements compared with warm compresses in improving meibomian gland functionality in patients with lipid-deficient/evaporative dry eye disease (LDDE).
This single-center, open-label, investigator-masked, randomized study enrolled patients aged ≥18 years, clinically diagnosed with LDDE defined as having ≤6 functional meibomian glands [meibomian gland yielding liquid secretion (MGYLS)] and positive for dry eye symptoms at screening. Patients were randomized to receive either the combination treatment (lipid emulsion eye drops, omega-3 supplements, and lid hygiene with eyelid wipes) or to apply warm, wet compresses once daily, 8 minutes per day, for 3 months. Meibomian gland functionality (number of MGYLS; primary outcome) and patient-reported subjective assessments (SPEED and OSDI questionnaires; secondary outcomes) were evaluated. Adverse events (AEs) and visual acuity were assessed as safety endpoints.
Mean patient age was 41.7 years (n = 26; n = 13 per group). Mean ± SD number of MGYLS was not statistically significantly different between groups at baseline (combination treatment, 3.5 ± 1.5; warm compresses, 4.2 ± 1.4, P > 0.5), and was significantly greater with combination treatment versus warm compresses after 3 months of treatment (9.3 ± 2.7 vs. 4.7 ± 2.3; P = 0.006). Dry eye symptoms were significantly improved in both groups at all follow-up visits. Two AEs unrelated to treatment were reported; the BCVA was unchanged from baseline in both groups.
The combination treatment regimen resulted in significant improvement in meibomian gland functionality and dry eye symptoms. No safety issues were observed.
Korb Associates, Boston, MA.
Reprints: Caroline A. Blackie, OD, PhD, 400 Commonwealth Ave, Unit #2, Boston, MA 02215 (e-mail: email@example.com).
Supported by Alcon Research, Ltd, Fort Worth, TX.
D. R. Korb is the inventor or coinventor of and has financial interest in commercially marketed products including Systane Balance (Alcon Laboratories, Inc, Fort Worth, TX), Soothe XP, LipiView (TearScience, Morrisville, NC), LipiFlow (TearScience), and the Korb Meibomian Gland Evaluator (TearScience). C. A. Blackie and T. Douglass have financial interest in TearScience. V. M. Finnemore has no funding or conflicts of interest to disclose.
Received August 13, 2014
Received in revised form October 30, 2014
Accepted November 30, 2014