Vernal KeratoconjunctivitisNCT07138742
Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis
A study testing Steroid eye drops and Tacrolimus eye drops in people with Vernal Keratoconjunctivitis, run by Sohag University.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 5 to 15 years
- Conditions the study is for
- Vernal Keratoconjunctivitis
- What is being tested?
- Steroid eye drops and Tacrolimus eye drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with moderate to severe active VKC aged between (5-15) years old (pediatric age group)
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Engy Mohamed Ahmed, professor contact
About this study
Official title: Efficacy and Safety of Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis
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
Read the 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
- Conditions
- Vernal Keratoconjunctivitis
- Being tested
- Steroid eye drops, Tacrolimus eye drops
- Keywords
- vernal keratoconjunctivitis, Tacrolimus eye drops
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid eye dropsDrug
steroid eye drops will be used in control group as usual regimen in treatment of vernal keratoconjunctivitis
Tacrolimus eye dropsDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | This group will be treated by steroid eye drops Receives: Drug: Steroid eye drops |
| Intervention group 1 | Experimental | This group will be treated by compound Tacrolimus eye drop in 0.1% concentration Receives: Drug: Tacrolimus eye drops |
| Intervention group 2 | Experimental | This group will be treated by compound Tacrolimus eye drop in 0.01% concentration Receives: Drug: Tacrolimus eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: during loading period of drug intake ( 1 month )
visual acuity
management of acute episodes : with follow up of visual acuity using snellen chart
Measured: during loading period of drug intake ( 1 month )
IOP measurement
management of acute episodes : with follow up IOP measurement in mmHg using applanation tonometry
Measured: during loading period of drug intake ( 1 month )
Secondary outcomes (1)
time of persistence
Reduction of exacerbations of inflammatory manifestations
Measured: during maintenance period of drug intake ( 2 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study startSep 2025 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vernal KeratoconjunctivitisStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Esraa Ahmed Okasha, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07138742
- Sponsor's protocol ID
- Soh-Med-25-7-5MD
- Status last verified
- Aug 2025
- First submitted
- 8 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 28803239Zhao 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.
PubMed 33144336Gokhale 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.
PubMed 27050351
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tacrolimus Eye Drops in Treatment of Vernal Keratoconjunctivitis
- ClinicalTrials.gov ID
- NCT07138742
- Acronym / sponsor ID
- Soh-Med-25-7-5MD
- Conditions
- Vernal Keratoconjunctivitis
- Keywords
- vernal keratoconjunctivitis, Tacrolimus eye drops
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Drug: Steroid eye dropsThis group will be treated by steroid eye drops |
| Intervention group 1 | Experimental | Drug: Tacrolimus eye dropsThis group will be treated by compound Tacrolimus eye drop in 0.1% concentration |
| Intervention group 2 | Experimental | Drug: Tacrolimus eye dropsThis group will be treated by compound Tacrolimus eye drop in 0.01% concentration |
Who may qualify
- Ages
- 5 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with moderate to severe active VKC aged between (5-15) years old (pediatric age group)
Key exclusion criteria (8 listed)
- Coexisting eye infections
- Contact lens use
- Systemic immunosuppressive drug use
- Herpes keratitis
- Recent ocular surgery or trauma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Steroid eye dropssteroid eye drops will be used in control group as usual regimen in treatment of vernal keratoconjunctivitis | Drug | Control group |
| Tacrolimus eye dropsCompound 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 | Drug | Intervention group 1, Intervention group 2 |
Primary outcome
Total subjective symptoms score (TSSS)
Time frame: during loading period of drug intake ( 1 month )
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)
Total objective ocular signs score (TOSS)
Time frame: during loading period of drug intake ( 1 month )
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)
visual acuity
Time frame: during loading period of drug intake ( 1 month )
management of acute episodes : with follow up of visual acuity using snellen chart
IOP measurement
Time frame: during loading period of drug intake ( 1 month )
management of acute episodes : with follow up IOP measurement in mmHg using applanation tonometry
1 secondary outcome
time of persistence
Time frame: during maintenance period of drug intake ( 2 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Results publication: PubMed 28803239Wan 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.
- Results publication: PubMed 33144336Zhao 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.
- Results publication: PubMed 27050351Gokhale 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Engy Mohamed Ahmed, professor contact
Questions about this trial
What is this clinical trial studying?
A study testing Steroid eye drops and Tacrolimus eye drops in people with Vernal Keratoconjunctivitis, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Esraa Ahmed Okasha, assistant lecturer (01028909988, esraa011037@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total subjective symptoms score (TSSS) (time frame: during loading period of drug intake ( 1 month )). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07138742, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.