Szczotka-Flynn Loretta B, Debanne Sara, Benetz Beth Ann, Wilson Tawnya, Brennan Noel
University Hospitals Eye Institute (L.B.S.-F., B.A.B.), University Hospitals Case Medical Center, Cleveland, OH; Departments of Ophthalmology and Visual Sciences (L.B.S.-F., B.A.B.), and Epidemiology and Biostatistics (S.D.), Case Western Reserve University, Cleveland, OH; and Johnson & Johnson Vision Care, Inc. (T.W., N.B.), Jacksonville, FL.
Eye Contact Lens. 2018 May;44(3):190-199. doi: 10.1097/ICL.0000000000000335.
This study hypothesized that a traditional high-water contact lens of moderate oxygen transmissibility (Dk/t) is noninferior to common silicone hydrogel (SH) lenses worn for daily wear with respect to measures of hypoxic stress.
Thirty-six habitual contact lens wearers completed wear of three lens types worn in a randomized order: etafilcon A (ACUVUE 2, control), lotrafilcon B (Air Optix Aqua), and comfilcon A (Biofinity). Central corneal thickness (CT) and limbal hyperemia were measured >2 hr after waking and after 6 to 8 hr of wear on days 1 and 7. Endothelial bleb formation was measured on day 1 of each lens type. Noninferiority of etafilcon A, with respect to the other two lens types, was assumed if the following difference margins of equivalence were met: <1.5% for corneal swelling, <0.5 grade for limbal hyperemia, and <1% area of endothelial blebs. Outcomes were modeled using generalized linear mixed modeling techniques.
All lenses showed reductions in least-square mean estimates of CT on both days: etafilcon A -0.26% at day 1 and -0.31% at day 7; lotrafilcon B -1.11% at day 1 and -1.06% at day 7; comfilcon A -0.63% at day 1 and -0.84% at day 7. The difference in mean swelling between etafilcon A and lotrafilcon B was 0.85% at day 1 (95% confidence interval [0.4%-1.3%]) and 0.75% at day 7 (0.3%-1.2%). The difference in mean swelling between etafilcon A and comfilcon A was 0.37% at day 1 (-0.1% to 0.8%) and 0.53% at day 7 (0.1%-1.0%). For limbal redness, etafilcon A fell within 0.1 grade of lotrafilcon B and 0.18 grade of comfilcon A. For endothelial bleb formation, etafilcon A fell within 0.45% of lotrafilcon B and 0.23% of comfilcon A.
The etafilcon A control lens resulted in corneal deswelling throughout the day as did the SH lens types. Limbal hyperemia and endothelial bleb formation with all lenses were negligible, and noninferiority assumptions were met between the lens types for all outcomes. Equivalence of etafilcon A with respect to the two SH lenses for three measures of hypoxic stress was demonstrated.
本研究假设，一款具有中等氧透性（Dk/t）的传统高含水量隐形眼镜在缺氧应激指标方面不劣于日常佩戴的普通硅水凝胶（SH）镜片。
36名隐形眼镜习惯性佩戴者按随机顺序佩戴三种镜片：依他氟康A（ACUVUE 2，对照）、洛替氟康B（爱尔康水润）和康菲康A（博士伦纯视）。在第1天和第7天，醒来后2小时以上以及佩戴6至8小时后测量中央角膜厚度（CT）和角膜缘充血情况。在每种镜片佩戴的第1天测量内皮小泡形成情况。如果满足以下等效差异界限，则假定依他氟康A相对于其他两种镜片不劣：角膜肿胀<1.5%，角膜缘充血<0.5级，内皮小泡面积<1%。使用广义线性混合建模技术对结果进行建模。
所有镜片在两天的CT最小二乘均值估计值均有所降低：依他氟康A在第1天为-0.26%，第7天为-0.31%；洛替氟康B在第1天为-1.11%，第7天为-1.06%；康菲康A在第1天为-0.63%，第7天为-0.84%。依他氟康A和洛替氟康B之间的平均肿胀差异在第1天为0.85%（95%置信区间[0.4%-1.3%]），第7天为0.75%（0.3%-1.2%）。依他氟康A和康菲康A之间的平均肿胀差异在第1天为0.37%（-0.1%至0.8%），第7天为0.53%（0.1%-1.0%）。对于角膜缘发红，依他氟康A与洛替氟康B相差0.1级，与康菲康A相差0.18级。对于内皮小泡形成，依他氟康A与洛替氟康B相差0.45%，与康菲康A相差0.23%。
依他氟康A对照镜片与SH镜片类型一样，全天都能使角膜消肿。所有镜片的角膜缘充血和内皮小泡形成均可忽略不计，并且在所有结果方面各镜片类型之间均满足非劣效性假设。证明了依他氟康A在三种缺氧应激指标方面与两种SH镜片等效。
