Ultrastructural Ocular Surface Safety Of A Novel Citrus-Derived Antiseptic Assessed By Scanning Electron Microscopy

To evaluate the ocular surface safety and ultrastructural effects of Oftasecur®, a Biosecur®-based citrus bioflavonoid antiseptic lubricant with previously demonstrated broad-spectrum antimicrobial activity, using scanning electron microscopy (SEM) of conjunctival impression cytology, with particular focus on conjunctival microvilli as early biomarkers of epithelial integrity.

The study was conducted at the Ophthalmology Unit of Salerno University Hospital, Salerno, Italy.

In this double-blind, controlled pilot study, 10 patients with mild dry eye disease (6 females, 4 males) were randomized to receive either Oftasecur® (n=5) or balanced saline solution (BSS; n=5) three times daily for 3 weeks.

Superior bulbar conjunctival impression cytology was performed at baseline (T0) and after treatment (T1). SEM analysis assessed microvilli density and morphology using a standardized grading system (Del Prete et al., 2008).

Exclusion criteria included: age <18 years, moderate-to-severe dry eye (NEI ≥2, Schirmer <10 mm, BUT <10 s, OSDI >22), ocular surface infection or inflammation within 3 months, ocular surgery within 6 months, or topical therapy within 4 weeks prior to enrollment.

At baseline, mean SEM microvilli scores were comparable between groups (2.00 ± 0.71 in the Oftasecur® group vs 2.60 ± 0.89 in BSS; p=0.42).

After 3 weeks, the Oftasecur® group demonstrated a significant improvement in microvilli density and integrity (1.40 ± 0.89; p=0.041), whereas no significant change was observed in the control group (2.60 ± 1.14; p=0.89).

At T1, microvilli integrity was significantly better in the Oftasecur® group compared to controls (p=0.048). Improvement was observed in 3/5 patients in the treatment arm, with stability in the remaining two. In contrast, four control patients remained unchanged and one showed ultrastructural worsening.

While antiseptic eye drops are essential for infection control, epithelial tolerability remains a critical concern for long-term use. SEM analysis demonstrated that Oftasecur® preserves—and may enhance—conjunctival microvilli without evidence of cytotoxicity.

These findings support its ocular surface biocompatibility and suggest that this citrus-derived antiseptic may represent a safe option for prolonged topical use. Larger randomized studies are warranted to confirm these preliminary results.