Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Steroid eye drops, Tacrolimus eye drops.
- Who it may be relevant to
- Registry conditions: Vernal Keratoconjunctivitis. Basic parameters: 5 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Safety of Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis
Overview
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
Interventions
- 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
Primary outcome measures
- Total subjective symptoms score (TSSS) [Time frame: during loading period of drug intake ( 1 month )]
- Total objective ocular signs score (TOSS) [Time frame: during loading period of drug intake ( 1 month )]
- visual acuity [Time frame: during loading period of drug intake ( 1 month )]
- IOP measurement [Time frame: during loading period of drug intake ( 1 month )]
Secondary outcome measures (1)
- time of persistence [Time frame: during maintenance period of drug intake ( 2 months)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- 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 28803239
- 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 33144336
- 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 27050351
Identifiers
NCT: NCT07138742 · Soh-Med-25-7-5MD