NCT07138742

Brief 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

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
16mo left

Started Sep 2025

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Sep 2025Sep 2027

First Submitted

Initial submission to the registry

August 8, 2025

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 24, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

September 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2027

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

August 24, 2025

Status Verified

August 1, 2025

Enrollment Period

1.5 years

First QC Date

August 8, 2025

Last Update Submit

August 22, 2025

Conditions

Vernal Keratoconjunctivitis

Keywords

vernal keratoconjunctivitis, Tacrolimus eye drops

Outcome Measures

Primary Outcomes (4)

  • Total subjective symptoms score (TSSS)

    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)

    during loading period of drug intake ( 1 month )

  • Total objective ocular signs score (TOSS)

    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)

    during loading period of drug intake ( 1 month )

  • visual acuity

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

    during loading period of drug intake ( 1 month )

  • IOP measurement

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

    during loading period of drug intake ( 1 month )

Secondary Outcomes (1)

  • time of persistence

    during maintenance period of drug intake ( 2 months)

Study Arms (3)

Control group

ACTIVE COMPARATOR

This group will be treated by steroid eye drops

Drug: Steroid eye drops

Intervention group 1

EXPERIMENTAL

This group will be treated by compound Tacrolimus eye drop in 0.1% concentration

Drug: Tacrolimus eye drops

Intervention group 2

EXPERIMENTAL

This group will be treated by compound Tacrolimus eye drop in 0.01% concentration

Drug: Tacrolimus eye drops

Interventions

Steroid eye dropsDRUG

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

Control group
Tacrolimus eye dropsDRUG

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

Intervention group 1Intervention group 2

Eligibility Criteria

Age5 Years - 15 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Wan Q, Tang J, Han Y, Wang D, Ye H. Therapeutic Effect of 0.1% Tacrolimus Eye Drops in the Tarsal Form of Vernal Keratoconjunctivitis. Ophthalmic Res. 2018;59(3):126-134. doi: 10.1159/000478704. Epub 2017 Aug 12.

    PMID: 28803239RESULT

  • Zhao M, He F, Yang Y, Lin W, Qiu W, Meng Q, Zhang J, Zhou Z. Therapeutic efficacy of tacrolimus in vernal keratoconjunctivitis: a meta-analysis of randomised controlled trials. Eur J Hosp Pharm. 2022 May;29(3):129-133. doi: 10.1136/ejhpharm-2020-002447. Epub 2020 Nov 3.

    PMID: 33144336RESULT

  • Gokhale NS. Systematic approach to managing vernal keratoconjunctivitis in clinical practice: Severity grading system and a treatment algorithm. Indian J Ophthalmol. 2016 Feb;64(2):145-8. doi: 10.4103/0301-4738.179727.

    PMID: 27050351RESULT

MeSH Terms

Conditions

Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Central Study Contacts

Esraa Ahmed Okasha, assistant lecturer

CONTACT

01028909988esraa011037@med.sohag.edu.eg

Engy Mohamed Ahmed, professor

CONTACT

01005643587

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

August 8, 2025

First Posted

August 24, 2025

Study Start

September 1, 2025

Primary Completion (Estimated)

March 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

August 24, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share