Safety and Efficacy of Tacrolimus Ointment 0.03 % as a Steroid-Sparing Regimen in Patients with Severe or Refractory Vernal Keratoconjunctivitis (VKC): A study from Quetta, Balochistan

Abstract

Background: Vernal keratoconjunctivitis (VKC) is a chronic, seasonally exacerbated ocular surface disease of childhood for which steroid-sparing therapy is desirable. We evaluated the safety and efficacy of tacrolimus 0.03% ointment in severe or refractory VKC over 12 months.
Methodology: This was a single-arm, non-randomized, prospective interventional study (no comparator group) conducted over 12 months (July 2024–June 2025) at Helpers Eye Hospital, Quetta, Pakistan. Ninety children (5–20 years) with severe or refractory VKC, enrolled by consecutive sampling, received tacrolimus 0.03% ointment nightly for 4–6 months. Symptom and sign scores (0–12 composite) and intraocular pressure (IOP) were recorded at baseline, 6, and 12 months and analyzed in SPSS v25.0 using paired t-tests. Primary outcome: change in composite symptom and sign scores from baseline; secondary outcomes: symptom, sign, and composite responder rates (≥50% reduction) at 12 months, and overall safety status.
Results: Lost to follow-up at 12 months was 13/90 (14.4%). Composite symptom scores improved by 4.66 at 6 months and 5.56 at 12 months (both p<0.001); composite sign scores improved by 1.77 and 2.78, respectively (both p<0.001). IOP remained stable at both time points. At 12 months, symptom responders were 69%, sign responders 3%, and composite responders 1%; safety was observed in 94%.
Conclusions: In severe/refractory pediatric VKC, tacrolimus 0.03% ointment was associated with large symptom improvement, moderate sign improvement, and favorable safety through 12 months, with stable IOP. When composite thresholds are strict, domain-specific responder reporting is helpful in clarifying clinical benefit. The results are supportive of tacrolimus 0.03% ointment being a practical steroid-sparing treatment.