Objective: To assess the changes in eyelid margins associated with eyelid hygiene using Blephaclean eye pads to manage anterior blepharitis or meibomian gland dysfunction (MGD) associated with dry eye complaints.
Method: The investigation was a bilateral, prospective, interventional, open-label investigation of 3-month duration. The test population included dry eye sufferers with at least mild symptoms (Ocular Surface Disease Index ≥ 13) who presented with mild to moderate anterior blepharitis or MGD. Eyelid hygiene was intensive (twice a day) for the initial 3 weeks and a maintenance regimen (once a day) for the remainder of the study. At each visit, a detailed assessment of eyelid margins was performed. This assessment included the rating of lashes contamination, lid margin foam, droplet, redness and staining, and meibomian gland blockage, dropout, and expression.
Result: Forty subjects aged 22 to 74 years (54 ± 15 years) were enrolled of whom 39 completed the investigation. The product usage revealed good overall compliance throughout the study. The results revealed a significant improvement in eyelid margin status. Significant (P<0.001) decrease in contamination of eyelashes and meibomian gland blockage were recorded at the completion of the initial 3-week intensive phase and maintained over the 3-month study during the maintenance phase. Meibomian gland expression, indicative of the glands functionality, was also significantly better at the completion of both study phases (intensive P=0.003; maintenance P=0.001). A decrease in eyelid margin staining was also observed but was only significant at the 3-month follow-up at the completion of the maintenance phase.
Conclusion: The results showed that eyelid hygiene with Blephaclean wipes by subjects with anterior blepharitis or MGD significantly improved the status of the eyelid margin tissues including the meibomian glands. The data confirmed the efficiency of the clinical methodology put forward of 3 weeks of intensive use (twice a day) of eyelid wipes followed by maintenance use (once a day) and that approach achieved a rapid improvement in tissue status and gland patency.
OTG Research & Consultancy, London, United Kingdom.
Address correspondence and reprint requests to Michel Guillon, Ph.D., F.C.Optom., F.A.A.O., F.B.C.L.A., C.C.T.I., OTG Research & Consultancy, 66 Buckingham Gate, London SW1E 6AU, United Kingdom; e-mail: firstname.lastname@example.org
This work was financially supported by Spectrum Théa Ltd.
The authors have no conflicts of interest to disclose.
Accepted July 7, 2012