Randomized masked trial of the clinical efficacy of MGO Manuka Honey microemulsion eye cream for the treatment of blepharitis.

PURPOSE: To assess the clinical efficacy of a novel MGO Manuka Honey microemulsion (MHME) eye cream for the management of blepharitis. METHODS: Fifty-three participants (32 females, 21 males; mean ± SD age, 60 ± 12 years) with clinical signs of blepharitis were enrolled in a prospective, investigator-masked, randomized, paired-eye trial. The MHME eye cream (Manuka Health New Zealand) was applied to the closed eyelids of one eye (randomized) overnight for 3 months. Visual acuity, ocular surface characteristics, symptoms and tear film parameters were assessed at baseline, day 30, and day 90. Eyelid swab microbiology cultures were evaluated at baseline and day 90. RESULTS: Baseline measurements did not differ between treated and control eyes (all p > 0.05). Significant reductions in SANDE and SPEED symptomology scores were detected in treated eyes on days 30 and 90 (all p < 0.05), while clinical improvements in non-invasive tear film breakup time, lipid layer thickness, and inferior lid wiper epitheliopathy were observed on day 90 (all p < 0.05). Following the 3-month treatment period, ocular Demodex, Corynebacterium macginleyi, Propionibacterium acnes, and Staphylococcus epidermidis load decreased significantly in treated eyes (all p ≤ 0.001). There were no changes in visual acuity during the 90-day period (all p > 0.05), and no major adverse events were reported. CONCLUSION: Topical overnight application of the MHME eye cream effected significant improvements in ocular surface symptomology, tear film stability and lipid layer thickness, and reduced lid margin staining, ocular Demodex and bacterial load. The favourable clinical efficacy and tolerability profile suggests promise for the MHME eye cream as a treatment for blepharitis management. TRIAL REGISTRATION NUMBER: ACTRN12616000539437.

Comparing the in vitro effects of MGO™ Manuka honey and tea tree oil on ocular Demodex viability.

PURPOSE: To compare the in vitro antiparasitic effects of MGO™ Manuka honey and tea tree oil against ocular Demodex. METHODS: Fifty-two viable Demodex mites were acquired from the epilated eyelashes of 9 participants with blepharitis and symptomatic dry eye. Viable mites were randomised to one of five treatment groups: cyclodextrin-complexed and uncomplexed Manuka Honey, 100% and 50% tea tree oil, and no treatment. Following treatment application, mite viability was assessed for 240 min, based on limb and body movement and/or the development of a crenated/translucent appearance. Kaplan-Meier survival analysis was then performed. RESULTS: The log-rank test demonstrated a significant treatment effect on the survival distribution of Demodex mites (p < 0.001). Bonferroni-corrected post-hoc pairwise analysis showed that all treatments except for uncomplexed honey effected lower survival probabilities than the untreated group (all p < 0.001). Among the four treatments, survival probabilities were lowest with 100% tea tree oil (all p < 0.001), and highest with uncomplexed honey (all p ≤ 0.001). No difference was observed between complexed honey and 50% tea tree oil (p = 0.81). CONCLUSIONS: The in vitro efficacy of cyclodextrin-complexed Manuka honey was comparable with 50% tea tree oil, an established treatment for ocular Demodex. The findings support future clinical trials investigating the therapeutic effects of complexed honey in demodectic blepharitis patients.

Ocular surface microbiome in meibomian gland dysfunction.

BACKGROUND: To investigate the ocular microbiome in meibomian gland dysfunction in Auckland, New Zealand. DESIGN: Prospective, cross-sectional, observational, university-based study. PARTICIPANTS: Participants resident in New Zealand for ≥2 years (n = 157) were classified as normal (n = 66), mild (n = 41) or moderate-to-severe meibomian gland dysfunction (n = 50). Contact lens wear and anterior blepharitis status were recorded, as well as symptoms and clinical features. METHODS: Bacteria collected from lid margin swabs, before and after gland expression, were isolated and identified by conventional microbiological culture techniques. Aerobic isolates were identified in all 157 participants, and both aerobic and anaerobic bacteria isolated in a subset of 87 subjects. MAIN OUTCOME MEASURES: Bacterial incidence according to meibomian gland dysfunction status RESULTS: Symptoms, bulbar hyperaemia, conjunctival staining, lipid layer grade and tear film stability, but not corneal staining, showed moderate association with meibomian gland dysfunction severity. Participants with and without meibomian gland dysfunction showed a similar microbiome, unaffected by gland expression. Anterior blepharitis, a common co-morbidity, was not an independent predictor of the microbiome. Sterile cultures were more common in contact lens wearers than non-wearers. The incidence of Staphylococcus aureus was higher than anticipated across all severity groups, and that of coagulase-negative Staphylococcus, Corynebacterium and streptococci was lower. CONCLUSIONS: Modest differences in relative proportions of bacteria compared with other studies support climatic variations in the ocular surface microbiome. Similarity in microbiome profile, irrespective of meibomian gland dysfunction severity, anterior blepharitis presence or contact lens wear, suggests potential for commonality in treatment.

The natural history of corneal topographic progression of keratoconus after age 30†years in non-contact lens wearers.

BACKGROUND/AIMS: To determine if significant progression of disease occurs in older, non-contact lens wearing, subjects with keratoconus and to identify potential predictive factors. METHODS: Clinical and computerised corneal topography records of subjects with keratoconus attending a specialist optometry practice were retrospectively analysed to identify those aged ≥30 years, with ≥2 consultations ≥12 months apart, no contact lens wear and no corneal scarring, surgery or corneal hydrops. Topographic parameters assessed included: maximum keratometry (Kmax), steep keratometry (Ksteep), flat keratometry (Kflat), inferior-superior (I-S) ratio and the surface asymmetry and regularity (surface asymmetry index and surface regularity index) indices. RESULTS: Of the 449 subjects with keratoconus assessed, 43 eyes of 27 patients (6.01%) met inclusion criteria, with median age 38.45 (12.86) years at baseline and median follow-up 4.36 (8.68) years. There was a significant increase in Kmax (0.30 (1.21) D), Ksteep (0.27 (0.90) D), Kflat (0.34 (1.12) D) and I-S (0.26 (0.82) D) between baseline and final review, p<0.05. Notably, 18.6%-25.6% of eyes demonstrated ≥1.00 D increase in one or more of four principal topographic parameters (Kmax, Ksteep, Kflat, I-S ratio), while 18.5%-37.0% of subjects had ≥1.00 D increase in the aforementioned parameters in at least one eye over the study period. However, <10% of eyes exhibited ≥1.00 D increase/year in all topographic parameters. The only significant predictor of progression was follow-up time. CONCLUSIONS: This study confirms that keratoconus may continue to progress beyond age 30. Older subjects with keratoconus should be monitored for progression, particularly with respect to possible corneal collagen cross-linking or astigmatic correction in cataract surgery.

Preclinical development of MGO Manuka Honey microemulsion for blepharitis management.

OBJECTIVE: To evaluate the in vitro antimicrobial effects of cyclodextrin-complexed and uncomplexed Manuka honey on bacteria commonly associated with blepharitis, and in vivo rabbit eye tolerability of a cyclodextrin-complexed methylglyoxal (MGO) Manuka Honey microemulsion (MHME). METHODS AND ANALYSIS: In vitro phase: Bacterial growth inhibition was assessed by area under the growth curve (AUC) for Staphylococcus aureus, and the minimum inhibitory concentration (MIC) and minimum bactericidal concentration (MBC) for S. aureus, Staphylococcus epidermidis and Pseudomonas aeruginosa with cyclodextrin-complexed and uncomplexed Manuka honey were determined. In vivo phase: Six rabbits were administered 20 µL of MHME (at 1:10 dilution) to the right eye (treated) and 20 µL of saline to the left eye (control) daily, for 5 days. Tear evaporation, production, osmolarity, lipid layer, conjunctival hyperaemia and fluorescein staining were assessed daily, before and 15 min after instillation. RESULTS: In vitro phase: The relative AUC for cyclodextrin-complexed Manuka honey was lower than that of uncomplexed honey at both 250 and 550 mg/kg of MGO (both p <0.05). Cyclodextrin-complexed honey had lower MIC and MBC than uncomplexed honey for both S. aureus and S. epidermidis, but not P. aeruginosa. In vivo phase: No significant changes were observed in the parameters assessed in either treated or control eyes (all p >0.05). CONCLUSION: Overall, antimicrobial potency of cyclodextrin-complexed Manuka honey was greater than uncomplexed honey. No significant immediate or cumulative adverse effects were observed with MHME application on rabbit eyes, supporting future conduct of clinical safety and tolerability trials in human subjects.

Randomised masked trial of the clinical safety and tolerability of MGO Manuka Honey eye cream for the management of blepharitis.

OBJECTIVE: To assess the clinical safety and tolerability of a novel MGO Manuka Honey microemulsion (MHME) eye cream for the management of blepharitis in human subjects. METHODS AND ANALYSIS: Twenty-five healthy subjects were enrolled in a prospective, randomised, paired-eye, investigator-masked trial. The MHME eye cream (Manuka Health New Zealand) was applied to the closed eyelids of one eye (randomised) overnight for 2 weeks. LogMAR visual acuity, eyelid irritation symptoms, ocular surface characteristics and tear film parameters were assessed at baseline, day 7 and day 14. Expression of markers of ocular surface inflammation (matrix metalloproteinase-9 and interleukin-6) and goblet cell function (MUC5AC) were quantified using impression cytology at baseline and day 14. RESULTS: There were no significant changes in visual acuity, eyelid irritation symptoms, ocular surface characteristics, tear film parameters and inflammatory marker expression during the 2-week treatment period in treated and control eyes (all p>0.05), and measurements did not differ significantly between eyes (all p>0.05). No major adverse events were reported. Two subjects experienced transient ocular stinging, presumably due to migration of the product into the eye, which resolved following aqueous irrigation. CONCLUSION: The MHME eye cream application was found to be well tolerated in healthy human subjects and was not associated with changes in visual acuity, ocular surface characteristics, tear film parameters, expression of markers of inflammation or goblet cell function. The findings support future clinical efficacy trials in patients with blepharitis. TRIAL REGISTRATION NUMBER: ACTRN12616000540415.