NCT07138742

Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis

Efficacy and Safety of Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Sohag University · Academic / Other
• Sex: All
• Age: 5 Years – 15 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate efficacy and safety of topical Tacrolimus eye drops in different concentrations in treatment of vernal keratoconjunctivitis (VKC) comparing it with Steroid based usual topical regimen

Detailed description

A hospital- based Prospective comparative randomized open label controlled trial . the study will be conducted on Patients with moderate to severe active VKC aged between (5-15) years old (pediatric age group). they will be divided into 2 groups control group will be treated with usual regimen ( steroid based) interventional group will be subdivided into 2 groups and each will be treated with Tacrolimus eye drops in 2 different concentrations Follow up visits: Will be scheduled 1st week , 2nd week then 4th week during the loading period Then every 2 weeks during the maintenance period Then monthly for another 3 months

Conditions

• Vernal Keratoconjunctivitis

Interventions

Type	Name	Description
DRUG	Steroid eye drops	steroid eye drops will be used in control group as usual regimen in treatment of vernal keratoconjunctivitis
DRUG	Tacrolimus eye drops	Compound Tacrolimus eye drops in 2 different concentrations will be assessed in treatment of vernal keratoconjunctivitis in terms of efficacy and safety being compared with steroid eye drops

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-03-01
• Completion: 2027-09-01
• First posted: 2025-08-24
• Last updated: 2025-08-24