Caterina Gagliano1,2,3, Vincenzo Papa4, Roberta Amato1, Giulia Malaguarnera1,2, Teresio Avitabile2. 1. a Neurovisual Science Technology (NEST) , Catania , Italy. 2. b Department of Ophthalmology , University of Catania , Catania , Italy. 3. d Eye Clinic S.Marta Hospital , Catania , Italy. 4. c Medical Affairs SIFI SpA , Catania , Italy.
Abstract
Purpose/aim of the study: The purpose of this study was to measure the pre-corneal retention time of two marketed formulations (eye drops and eye gel) of a steroid-antibiotic fixed combination (FC) containing 0.1% dexamethasone and 0.3% netilmicin. MATERIALS AND METHODS:Pre-corneal retention time was evaluated in 16 healthy subjects using anultrahigh-resolution anterior segment spectral domain optical coherence tomography (OCT). All subjects randomly received both formulations of the FC (Netildex, SIFI, Italy). Central tear film thickness (CTFT) was measured before instillation (time 0) and then after 1, 10, 20, 30, 40 50, 60 and 120 min. The pre-corneal retention time was calculated by plotting CTFT as a function of time. Differences between time points and groups were analyzed by Student's t-test. RESULTS:CTFT increased significantly after the instillation of the eye gel formulation (p < 0.001). CTFT reached its maximum value 1 min after instillation and returned to baseline after 60 min. No effect on CTFT was observed after the instillation of eye drops. The difference between the two formulations was statistically significant at time 1 min (p < 0.0001), 10 min (p < 0.001) and 20 min (p < 0.01). CONCLUSIONS: The FC formulated as eye gel was retained on the ocular surface longer than the corresponding eye drop solution. Consequently, the use of the eye gel might extend the interval between instillations and decrease the frequency of administration.
RCT Entities:
Purpose/aim of the study: The purpose of this study was to measure the pre-corneal retention time of two marketed formulations (eye drops and eye gel) of a steroid-antibiotic fixed combination (FC) containing 0.1% dexamethasone and 0.3% netilmicin. MATERIALS AND METHODS: Pre-corneal retention time was evaluated in 16 healthy subjects using an ultrahigh-resolution anterior segment spectral domain optical coherence tomography (OCT). All subjects randomly received both formulations of the FC (Netildex, SIFI, Italy). Central tear film thickness (CTFT) was measured before instillation (time 0) and then after 1, 10, 20, 30, 40 50, 60 and 120 min. The pre-corneal retention time was calculated by plotting CTFT as a function of time. Differences between time points and groups were analyzed by Student's t-test. RESULTS:CTFT increased significantly after the instillation of the eye gel formulation (p < 0.001). CTFT reached its maximum value 1 min after instillation and returned to baseline after 60 min. No effect on CTFT was observed after the instillation of eye drops. The difference between the two formulations was statistically significant at time 1 min (p < 0.0001), 10 min (p < 0.001) and 20 min (p < 0.01). CONCLUSIONS: The FC formulated as eye gel was retained on the ocular surface longer than the corresponding eye drop solution. Consequently, the use of the eye gel might extend the interval between instillations and decrease the frequency of administration.
Entities:
Keywords:
OCT; Xanthan gum; dexamethasone; netilmicin; tear film thickness
Authors: Antonio Rapisarda; Paolo Arpa; Paolo Maria Fantaguzzi; Francesco Faraldi; Roberto Ratiglia; Stanislao Rizzo; Paola Vaona; Claudio Iannacone; Vincenzo Papa Journal: Clin Ophthalmol Date: 2020-10-14