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NCT Number: NCT07138742

Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis

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

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Key information

Conditions

Vernal Keratoconjunctivitis Conjunctival Diseases Conjunctivitis Conjunctivitis, Allergic Eye Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases

Age range

5 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with moderate to severe active VKC aged between (5-15) years old (pediatric age group)

Exclusion criteria

  • Coexisting eye infections
  • Contact lens use
  • Systemic immunosuppressive drug use
  • Herpes keratitis
  • Recent ocular surgery or trauma
  • Known hypersensitivity to Tacrolimus
  • Ophthalmological comorbidities as cataract, glaucoma, and congenital eye anomalies
  • Impaired renal or hepatic functions

Treatment and study plan

Steroid eye drops

Drug

steroid eye drops will be used in control group as usual regimen in treatment of vernal keratoconjunctivitis

Tacrolimus eye drops

Drug

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

Primary outcomes

  1. Total subjective symptoms score (TSSS)

    Time frame: during loading period of drug intake ( 1 month )

    management of acute episodes : through Assessment of change in severity scores for symptoms and signs of inflammation from base line depending on Total subjective symptoms score (TSSS)

  2. Total objective ocular signs score (TOSS)

    Time frame: during loading period of drug intake ( 1 month )

    management of acute episodes : through Assessment of change in severity scores for symptoms and signs of inflammation from base line depending on Total objective ocular signs score (TOSS)

  3. visual acuity

    Time frame: during loading period of drug intake ( 1 month )

    management of acute episodes : with follow up of visual acuity using snellen chart

  4. IOP measurement

    Time frame: during loading period of drug intake ( 1 month )

    management of acute episodes : with follow up IOP measurement in mmHg using applanation tonometry

Secondary outcomes

  1. time of persistence

    Time frame: during maintenance period of drug intake ( 2 months)

    Reduction of exacerbations of inflammatory manifestations

Study contacts

Contact information is provided by the study sponsor or research team.

Engy Mohamed Ahmed, professor

CONTACT

01005643587

Esraa Ahmed Okasha, assistant lecturer

CONTACT

[email protected]

01028909988

Sponsors and collaborators

Lead sponsor

Sohag University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2025
Registry last updated
Aug 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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