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RESEARCH PRODUCT

Efficacy and safety study of an eyelid gel after repeated nocturnal application in healthy contact lens users and non-users

Jorge Raga-cerveraMaria D Pinazo-duranSilvia M. Sanz-gonzálezJavier Benítez-del-castilloVicente Zanon-morenoJosé Salgado-borgesAna I. RamírezAna I. Ramírez

subject

DHA docosahexaenoic acidNon usersFBUT fluorescein break-up timeALA alpha linolenic acidTDAH-AOX tridocosahexaenoin-antioxidantNCLU non contact lens users0302 clinical medicineLC PUFAs long chain polyunsaturated fatty acidsMedicineCL contact lensesOS ocular surfaceHA hyaluronic acidOSDI ocular surface disease indexDE dry eyeCLU contact lens usersCLDEQ contact lens dry eye questionnaireVEGF vascular endothelial growth factorDocosahexaenoic acidBMC biomicroscopymedicine.anatomical_structureMedicamentosCytokinesOftalmologíaOriginal ArticleBCVA best corrected visual acuitymedicine.medical_specialtyOcular surface dysfunctionCorneal stainingContact LensesHyaluronic acidRE right eyeDEs dry eye syndrome03 medical and health sciencesOphthalmologyHumansAdverse effectbusiness.industryEyelidsEPA eicosapentaenoic acidAnatomía ocularIOP intraocular pressureeye diseasesClinical trialContact lensMOISTURIZING GEL030221 ophthalmology & optometryTearsLE left eyeEyelidsense organsbusiness030217 neurology & neurosurgeryOptometry

description

Purpose: To evaluate skin biocompatibility of a nighttime hydrating eyelid gel and possible ocular surface effects in contact lens users (CLU) and non-contact lens users (NCLU). The formulation is registered as a medical device as Tridocosahexaenoine-AOX® (TDHA-AOX) (a concentrated DHA triglyceride), containing also hyaluronic acid (HA). Methods: A prospective, randomized, masked clinical trial was performed with 62 participants of both sexes, aged 20–70 years, split into: (1) CLU (n = 30) and (2) NCLU (n = 32). All participants were instructed to apply a single dose of the moisturizing gel (containing TDHA-AOX and HA) nightly to the upper and inner eyelids of their right eye (RE) only, and during 2 consecutive weeks. Personal interviews, questionnaires, ophthalmic examinations and reflex tear collection were performed. Ophthalmological parameters included ocular surface response and contact lens status. Levels of satisfaction/adverse events were also recorded. Biochemical parameters included basal and final determination of pro-inflammatory mediator molecules in tear samples by multiplex analyses. Statistics were done by the SPSS 24.0 program. Results: The CLU group had higher OS dysfunction than NCLU, but overall clinical parameters (corneal staining, and Schirmer/FBUT tests) and OSDI scores showed significant improvement in CLU individuals as compared to the NCLU participants, at the end of study. CLDEQ-8 scores pinpointed significant amelioration in initial risk of developing DEs by applying eyelid gel. Multiplex analyses demonstrated significantly lower VEGF expression levels (p < 0,05) in tears among the CLU compared to NCLU after nightly application of eyelid gel. Conclusions: Eyelid gel appeared to safely and efficiently provide hydration and decongestion of the skin and amelioration of the ocular surface during sleep.

yearjournalcountryeditionlanguage
2020-01-01
10.1016/j.optom.2019.12.002