1. Efficacy and safety study of an eyelid gel after repeated nocturnal application in healthy contact lens users and non-users
- Author
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Jorge Raga-Cervera, Maria D Pinazo-Duran, Silvia M. Sanz-González, Javier Benítez-del-Castillo, Vicente Zanon-Moreno, José Salgado-Borges, and Ana I. Ramírez
- Subjects
DHA, docosahexaenoic acid ,Non users ,FBUT, fluorescein break-up time ,ALA, alpha linolenic acid ,TDAH-AOX, tridocosahexaenoin-antioxidant ,NCLU, non contact lens users ,0302 clinical medicine ,LC PUFAs, long chain polyunsaturated fatty acids ,Medicine ,CL, contact lenses ,OS, ocular surface ,HA, hyaluronic acid ,OSDI, ocular surface disease index ,DE, dry eye ,CLU, contact lens users ,CLDEQ, contact lens dry eye questionnaire ,VEGF, vascular endothelial growth factor ,Docosahexaenoic acid ,BMC, biomicroscopy ,medicine.anatomical_structure ,Medicamentos ,Cytokines ,Oftalmología ,Original Article ,BCVA, best corrected visual acuity ,medicine.medical_specialty ,Ocular surface dysfunction ,Corneal staining ,Contact Lenses ,Hyaluronic acid ,RE, right eye ,DEs, dry eye syndrome ,03 medical and health sciences ,Ophthalmology ,Humans ,Adverse effect ,business.industry ,Eyelids ,EPA, eicosapentaenoic acid ,Anatomía ocular ,IOP, intraocular pressure ,eye diseases ,Clinical trial ,Contact lens ,MOISTURIZING GEL ,030221 ophthalmology & optometry ,Tears ,LE, left eye ,Eyelid ,sense organs ,business ,030217 neurology & neurosurgery ,Optometry - Abstract
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
- Published
- 2020