An interventional study of Steroid eye drops and Tacrolimus eye drops in Vernal Keratoconjunctivitis, sponsored by Sohag University. Not yet recruiting. Open to participants aged 5 Years to 15 Years. Per ClinicalTrials.gov, last updated 2025-08-24.
Sponsored by Sohag University · Not applicable, Interventional, and Treatment
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
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
210 studies on the registry are indexed under Conjunctivitis, Allergic; 18 are open to participants now.
This study's planned enrollment of 90 is close to the median of 87 across 174 interventional studies indexed under Conjunctivitis, Allergic.
Browse Conjunctivitis, Allergic studies →Sohag University is the lead sponsor of 1,230 studies on the registry; 636 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This group will be treated by steroid eye drops
Drug: Steroid eye drops
This group will be treated by compound Tacrolimus eye drop in 0.1% concentration
Drug: Tacrolimus eye drops
This group will be treated by compound Tacrolimus eye drop in 0.01% concentration
Drug: Tacrolimus eye drops
steroid eye drops will be used in control group as usual regimen in treatment of vernal keratoconjunctivitis
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
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)
Time frame: 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)
Time frame: during loading period of drug intake ( 1 month )
visual acuity
management of acute episodes : with follow up of visual acuity using snellen chart
Time frame: during loading period of drug intake ( 1 month )
IOP measurement
management of acute episodes : with follow up IOP measurement in mmHg using applanation tonometry
Time frame: during loading period of drug intake ( 1 month )
time of persistence
Reduction of exacerbations of inflammatory manifestations
Time frame: during maintenance period of drug intake ( 2 months)
No study locations are listed for this record.
Plan to share: No
Start is estimated for Sep 2025; primary completion for Mar 2027, 18 months later.
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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tacrolimus