Topical Tacrolimus in Vernal Keratoconjunctivitis

The Eye Center and The Eye Foundation for Research in Ophthalmology

Status and phase: Unknown; Phase 4

Conditions: Vernal Keratoconjunctivitis

Treatments: Drug: Topical tacrolimus

Study type: Interventional

Funder types: Other

Identifiers

NCT02456025

TEC 124

Details and patient eligibility

About

The main aim of this study is to evaluate the efficacy and safety of topical tacrolimus 0.01% eyedrops in patients with vernal keratoconjunctivitis.

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

Topical tacrolimus

Active Comparator group

Description:

20 eyes with active Vernal Keratoconjunctivitis

Treatment:

Drug: Topical tacrolimus

Placebo

Placebo Comparator group

Description:

20 eyes with active Vernal Keratoconjunctivitis

Treatment:

Drug: Topical tacrolimus