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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
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Active Comparator | This group will be treated by steroid eye drops |
|
| Intervention group 1 | Experimental | This group will be treated by compound Tacrolimus eye drop in 0.1% concentration |
|
| Intervention group 2 | Experimental | This group will be treated by compound Tacrolimus eye drop in 0.01% concentration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Steroid eye drops | Drug | steroid eye drops will be used in control group as usual regimen in treatment of vernal keratoconjunctivitis |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 ) |
| Measure | Description | Time Frame |
|---|---|---|
| time of persistence | Reduction of exacerbations of inflammatory manifestations | during maintenance period of drug intake ( 2 months) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esraa Ahmed Okasha, assistant lecturer | Contact | 01028909988 | esraa011037@med.sohag.edu.eg | |
| Engy Mohamed Ahmed, professor | Contact | 01005643587 |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28803239 | Result | 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. | |
| 33144336 | Result | 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. |
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| ID | Term |
|---|---|
| D003233 | Conjunctivitis, Allergic |
| ID | Term |
|---|---|
| D003231 | Conjunctivitis |
| D003229 | Conjunctival Diseases |
| D005128 | Eye Diseases |
| D006969 | Hypersensitivity, Immediate |
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| Tacrolimus eye drops | 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 |
|
| 27050351 | Result | 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. |
| D006967 |
| Hypersensitivity |
| D007154 | Immune System Diseases |