Vernal KeratoconjunctivitisPhase 4NCT02456025
Topical Tacrolimus in Vernal Keratoconjunctivitis
A Phase 4 study testing Topical tacrolimus in people with Vernal Keratoconjunctivitis, run by The Eye Center and The Eye Foundation for Research in Ophthalmology at 1 site in Saudi Arabia.
Trial summary
The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Vernal Keratoconjunctivitis
- What is being tested?
- Topical tacrolimus
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Apr 2013to Dec 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- with bilateral symmetrical palpebral and limbal vernal keratoconjunctivitis
- Patients 6-18 years of age
Who cannot join
- Pregnant patients
- Patients on systemic therapy for other allergic disorders
- Patients who cannot come for follow-up
- Patients who are on other topical medications for other comorbid ocular conditions
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site, 1 recruiting
- Recruiting
The Eye Center
Riyadh
Samir S Shoughy, 0096614649614, samir.shawki@hotmail.com
Khalid F Tabbara, 0096614649614, k.tabbara@nesma.net.sa
About this study
The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis.
Read the detailed description
A total of 20 patients with bilateral symmetrical vernal keratoconjunctivitis will be included. Each patient will undergo a complete ophthalmologic evaluation. Patient will be placed at random on topical Tacrolimus 0.01% ophthalmic solution in one eye and placebo eyedrops in the fellow eye. Patients will undergo ophthalmologic examination at one week and after one month. Photos will be taken. The outcome measures include graded symptoms, graded signs, and laboratory investigations. Symptoms of itching, redness, foreign body sensation, tearing and discharge following will be recorded before and after treatment. The grading of clinical signs of conjunctival hyperemia, conjunctival papillary hypertrophy, perilimbal infiltrates, Trantas dots, superficial punctate keratopathy will be recorded before and after treatment. Conjunctival surface temperature will be determined before and after treatment. Conjunctival scrapings will be stained with Giemsa and will be assessed before and after therapy and number of eosinophils per hpf will be determined and recorded.
- Conditions
- Vernal Keratoconjunctivitis
- Being tested
- Topical tacrolimus
- Medical subject headings
- Conjunctivitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Topical tacrolimusDrug
Also called Tacrolimus eye drops
Topical tacrolimus 0.01% twice daily for one month
| Study group | Role | What they receive |
|---|---|---|
| Topical tacrolimus | Active comparator | 20 eyes with active Vernal Keratoconjunctivitis Receives: Drug: Topical tacrolimus |
| Placebo | Placebo comparator | 20 eyes with active Vernal Keratoconjunctivitis Receives: Drug: Topical tacrolimus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis
To evaluate the efficacy of topical tacrolimus 0.01 eye drops in patients with vernal keratoconjunctivitis in symptoms of redness, itching, foreign body sensation and discharge and signs of conjunctival hyperemia,perlimbal infiltrates, Trantas dots and papillary reaction
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2015 (estimated)
- Study startApr 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vernal KeratoconjunctivitisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Eye Center and The Eye Foundation for Research in Ophthalmology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samir S. Shoughy, MD, FRCS (Glasg.), The Eye Center and The Eye Foundation for Research in Ophthalmology
- Investigators
- Samir S Shoughy, Principal investigator, THE EYE CENTER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02456025
- Sponsor's protocol ID
- TEC 124
- Status last verified
- Nov 2015
- First submitted
- 18 Aug 2013
- Last updated
- 24 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Topical Tacrolimus in Vernal Keratoconjunctivitis
- ClinicalTrials.gov ID
- NCT02456025
- Acronym / sponsor ID
- TEC 124
- Conditions
- Vernal Keratoconjunctivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Eye Center and The Eye Foundation for Research in OphthalmologyUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 28 May 2015 (estimated)
- 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 main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis.
Detailed description
A total of 20 patients with bilateral symmetrical vernal keratoconjunctivitis will be included. Each patient will undergo a complete ophthalmologic evaluation. Patient will be placed at random on topical Tacrolimus 0.01% ophthalmic solution in one eye and placebo eyedrops in the fellow eye. Patients will undergo ophthalmologic examination at one week and after one month. Photos will be taken. The outcome measures include graded symptoms, graded signs, and laboratory investigations. Symptoms of itching, redness, foreign body sensation, tearing and discharge following will be recorded before and after treatment. The grading of clinical signs of conjunctival hyperemia, conjunctival papillary hypertrophy, perilimbal infiltrates, Trantas dots, superficial punctate keratopathy will be recorded before and after treatment. Conjunctival surface temperature will be determined before and after treatment. Conjunctival scrapings will be stained with Giemsa and will be assessed before and after therapy and number of eosinophils per hpf will be determined and recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Topical tacrolimus | Active comparator | Drug: Topical tacrolimus20 eyes with active Vernal Keratoconjunctivitis |
| Placebo | Placebo comparator | Drug: Topical tacrolimus20 eyes with active Vernal Keratoconjunctivitis |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- with bilateral symmetrical palpebral and limbal vernal keratoconjunctivitis
- Patients 6-18 years of age
Key exclusion criteria (4 listed)
- Pregnant patients
- Patients on systemic therapy for other allergic disorders
- Patients who cannot come for follow-up
- Patients who are on other topical medications for other comorbid ocular conditions
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 |
|---|---|---|
| Topical tacrolimusAlso: Tacrolimus eye dropsTopical tacrolimus 0.01% twice daily for one month | Drug | Placebo, Topical tacrolimus |
Primary outcome
The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis
Time frame: Five months
To evaluate the efficacy of topical tacrolimus 0.01 eye drops in patients with vernal keratoconjunctivitis in symptoms of redness, itching, foreign body sensation and discharge and signs of conjunctival hyperemia,perlimbal infiltrates, Trantas dots and papillary reaction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2015.
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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. This study is not recruiting at the moment.
Samir S Shoughy principal investigator
THE EYE CENTER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Topical tacrolimus in people with Vernal Keratoconjunctivitis, run by The Eye Center and The Eye Foundation for Research in Ophthalmology at 1 site in Saudi Arabia.
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 2 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 24 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Saudi Arabia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samir S Shoughy (0096614649614, samir.shawki@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis (time frame: Five months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2015.