MedDataX Logo

Topical Tacrolimus in Vernal Keratoconjunctivitis

NCT ID: NCT02456025

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Vernal Keratoconjunctivitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Topical tacrolimus

20 eyes with active Vernal Keratoconjunctivitis

Group Type ACTIVE_COMPARATOR

Topical tacrolimus

Intervention Type DRUG

Topical tacrolimus 0.01% twice daily for one month

Placebo

20 eyes with active Vernal Keratoconjunctivitis

Group Type PLACEBO_COMPARATOR

Topical tacrolimus

Intervention Type DRUG

Topical tacrolimus 0.01% twice daily for one month

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Topical tacrolimus

Topical tacrolimus 0.01% twice daily for one month

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Tacrolimus eye drops

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* with bilateral symmetrical palpebral and limbal vernal keratoconjunctivitis
* Patients 6-18 years of age

Exclusion Criteria

* 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
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

The Eye Center and The Eye Foundation for Research in Ophthalmology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Samir S. Shoughy, MD, FRCS (Glasg.)

Ophthalmologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Samir S Shoughy

Role: PRINCIPAL_INVESTIGATOR

THE EYE CENTER

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The Eye Center

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Saudi Arabia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Samir S Shoughy

Role: CONTACT

[email protected]
0096614649614

Khalid F Tabbara

Role: CONTACT

[email protected]
0096614649614

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Samir S Shoughy

Role: primary

[email protected]
0096614649614

Khalid F Tabbara

Role: backup

[email protected]
0096614649614

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TEC 124

Identifier Type: -

Identifier Source: org_study_id