Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis
NCT ID: NCT07138742
Last Updated: 2025-08-24
Study Results
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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NOT_YET_RECRUITING
NA
90 participants
INTERVENTIONAL
2025-09-30
2027-09-30
Brief Summary
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Detailed Description
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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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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control group
This group will be treated by steroid eye drops
Steroid eye drops
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
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 group 2
This group will be treated by compound Tacrolimus eye drop in 0.01% concentration
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
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
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
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
5 Years
15 Years
ALL
No
Sponsors
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Sohag University
OTHER
Responsible Party
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Esraa Ahmed Okasha
principle investigator
Central Contacts
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Engy Mohamed Ahmed, professor
Role: CONTACT
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.
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.
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.
Other Identifiers
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Soh-Med-25-7-5MD
Identifier Type: -
Identifier Source: org_study_id
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