Effect of Topical (0.03%) Tacrolimus Eye Ointment in the Management of Vernal Keratoconjunctivitis

Abstract

Background: Vernal keratoconjunctivitis (VKC) is a chronic, severe ocular inflammatory disorder predominantly affecting children and young adults. Current treatments, including antihistamines and corticosteroids, can have significant side effects, particularly with long-term use. Tacrolimus, a macrolide immunosuppressant, has emerged as a promising alternative due to its ability to inhibit T-cell proliferation and cytokine release, key factors in VKC pathogenesis.

Objective: To determine the efficacy and safety of 0.03% tacrolimus eye ointment in the management of vernal keratoconjunctivitis compared to standard steroid-based treatment.

Methods: This quasi-experimental study was conducted at the Department of Ophthalmology, Pak-Emirates Military Hospital, Rawalpindi, from January 2022 to May 2024. A total of 40 patients (80 eyes) diagnosed with VKC were included. Patients aged 5 to 60 years with bilateral VKC and no prior treatment in the last month were enrolled. Exclusion criteria included concurrent eye infections, use of contact lenses, systemic comorbidities, and previous ocular surgeries. The intervention group received 0.03% tacrolimus ointment twice daily for two months, followed by once daily for two months, and then on alternate days for the final two months. The control group received a combination of 0.1% fluorometholone eye drops, 0.3% tobramycin/0.1% dexamethasone ointment, and 0.1% olopatadine, with steroid tapering after two weeks. Patients were followed up at two weeks, one month, three months, and six months. The primary outcome was the change in symptom and sign scores from baseline to six months. Data were analyzed using SPSS version 25, with statistical significance set at p≤0.05.

Results: The median age of the study population was 15.50 years (IQR: 10.00), with 57.4% female. The tacrolimus group showed significant improvement in eye discharge (p=0.033), itching (p=0.004), lacrimation (p=0.008), and foreign body sensation (p=0.015) compared to the control group. The average symptom score decreased more significantly in the tacrolimus group (p<0.001). Clinical signs such as punctate keratitis (p=0.031) and papillae (p=0.018) also showed greater resolution in the tacrolimus group, with a significant reduction in the average sign score (p=0.009).

Conclusion: Topical 0.03% tacrolimus eye ointment is an effective and safe treatment for VKC, providing superior symptom relief and clinical improvement compared to standard steroid-based therapy. It offers a promising alternative for long-term management of VKC, with fewer side effects than traditional corticosteroids.