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Yureeda Qazi, Ahmad Kheirkhah, Thomas H Dohlman, Francisco Amparo, Reza Dana, Pedram Hamrah; Relative Efficacy of Loteprednol (Lotemax®) vs. Loteprednol-Tobramycin (Zylet®) on Corneal and Conjunctival Immune Response in Treatment of Meibomian Gland Dysfunction (MGD)-Associated Ocular Surface Inflammation: In Vivo Confocal Microscopy Results of a Phase IV Randomized Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2014;55(13):45.
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To use in vivo confocal microscopy (IVCM) to determine whether Zylet is superior to Lotemax in managing MGD-associated conjunctival inflammation and if either is more effective at treating inflammation than artificial tears.
An IRB-approved, phase IV, single-center, randomized, double-masked, vehicle-controlled clinical trial was conducted with 54 subjects (age = 56 ± 12 years) diagnosed with MGD and 62 age-matched normal controls (age = 49 ± 15 years). Subjects received artificial tears (AT; n= 20), Zylet only (n= 17), or Lotemax only (n= 17) for 4 weeks with follow-up (FUP) visits at 4 and 8 weeks post-initiation of treatment. IVCM of the central cornea and palpebral conjunctiva was done at baseline and 1st FUP visit. Imaging parameters included corneal immune dendritifom cell (DC) density, conjunctival epithelial (EIC) and stromal immune cell densities (SIC). Reliability tests for IVCM were performed. Symptom (Ocular Surface Disease Index questionnaire; OSDI) and ocular surface assessments were done at baseline and both FUP visits.
At baseline, subjects with clinical MGD had significantly increased corneal DC (P< 0.001), conjunctival EIC (P< 0.01) and SIC densities (P= 0.01). Imaging parameters were associated with symptoms (OSDI= 56 ± 3), low TBUT (3 ± 0.3s) and Schirmer’s scores (5 ± 0.8 mm). At the 1st FUP, improvement was detected in all imaging efficacy outcome measures in subjects treated with Zylet (DC: -49%, EIC: -29%, SIC: -14%) and Lotemax (DC:-58%, EIC: -34%, SIC: -32%) but not AT. Zylet and Lotemax reduced inflammation with comparable efficacy (DC: P= 0.6, EIC: P= 0.9, SIC= 0.4). There was a lag in symptomatic improvement, with 11% reduction in OSDI scores at the 1st FUP. IVCM had high inter-user agreement (intra-class correlation coefficient of agreement ≥ 0.93) with low bias.
Zylet and Lotemax are equally effective at reducing corneal and palpebral conjunctival inflammation in MGD and are superior to artificial tears. IVCM is a reliable tool in the quantitative detection and monitoring of ocular surface inflammation.
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