Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis

NCT ID: NCT07138742

Last Updated: 2025-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2027-09-30

Brief Summary

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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

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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

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Vernal Keratoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

This group will be treated by steroid eye drops

Group Type ACTIVE_COMPARATOR

Steroid eye drops

Intervention Type DRUG

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

Intervention group 1

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

Group Type EXPERIMENTAL

Tacrolimus eye drops

Intervention Type 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

Intervention group 2

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

Group Type EXPERIMENTAL

Tacrolimus eye drops

Intervention Type 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

Interventions

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Steroid eye drops

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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

1. Coexisting eye infections
2. Contact lens use
3. Systemic immunosuppressive drug use
4. Herpes keratitis
5. Recent ocular surgery or trauma
6. Known hypersensitivity to Tacrolimus
7. Ophthalmological comorbidities as cataract, glaucoma, and congenital eye anomalies
8. Impaired renal or hepatic functions
Minimum Eligible Age

5 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sohag University

OTHER

Sponsor Role lead

Responsible Party

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Esraa Ahmed Okasha

principle investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Esraa Ahmed Okasha, assistant lecturer

Role: CONTACT

01028909988

Engy Mohamed Ahmed, professor

Role: CONTACT

01005643587

References

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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.

Reference Type RESULT
PMID: 28803239 (View on PubMed)

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.

Reference Type RESULT
PMID: 33144336 (View on PubMed)

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.

Reference Type RESULT
PMID: 27050351 (View on PubMed)

Other Identifiers

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Soh-Med-25-7-5MD

Identifier Type: -

Identifier Source: org_study_id

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