Short-term effect of non-preserved cationic oil-in-water ophthalmic emulsion on tear meniscus parameters of healthy individuals in a prospective, controlled pilot study

Med Hypothesis Discov Innov Ophthalmol. 2021 May 31;10(1):5-10. doi: 10.51329/mehdiophthal1415. eCollection 2021 Spring.

Abstract

Background: This study investigated the effect of instilling a single drop of non-preserved cationic oil-in- water ophthalmic emulsion (Cationorm®) on the lower (LTM) and upper tear meniscus (UTM) parameters of normal eyes.

Methods: In this prospective, single-center, non-randomized, controlled pilot study, optical coherence tomography was used to estimate the UTM and LTM height, depth, and cross-sectional area in participants without a history of dry eye disease. In the right eye (study eye), we instilled one drop of Cationorm® in the lower conjunctival sac. Scans of the tear menisci were acquired at baseline, before the instillation, and at 5, 15, and 30 min thereafter. Control scans of the left eye (control eye) were obtained at the same timepoints. The tear meniscus parameters of the study eye were compared with the control eye at each timepoint.

Results: Twenty subjects (11 male and 9 female; mean [standard deviation] of age: 37.8 [10.9] years) were included in the study. Compared to the control eye, instillation of a single drop of Cationorm® resulted in significantly higher LTM parameter values and a higher UTM cross-sectional area up to 30 min after instillation (all P < 0.05). The UTM height and depth were significantly greater in the study eye than in the control eye up to 5 min (P < 0.001 and 0.007, respectively) and 15-min (P = 0.045, and 0.002, respectively) after Cationorm® instillation. In the study eye, Cationorm® resulted in a significant increase in LTM parameter values up to 30 min post-instillation (all P < 0.001). The UTM height was significantly greater up to 15 min post-instillation than at baseline. The UTM depth and area increased significantly from baseline to 5 min after instillation (P = 0.043, and 0.002, respectively).

Conclusions: Cationorm® seems to have a prolonged residence time on the ocular surface of healthy subjects as indicated by LTM parameters and to a lesser extent by UTM parameters.

Keywords: SD-OCT; cationorm; lower tear meniscus; ophthalmic emulsion; residence time; spectral domain-optical coherence tomography; upper tear meniscus.