Skip to main content
OpenTrials
Completed

NCT Number: NCT03464435

A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis

To evaluate the efficacy and safety of 0.1% tacrolimus combined with loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T) in vernal keratoconjunctivitis (VKC) patients resistant to conventional treatment. This prospective 6-mouth period study aims to include 20 severe VKC patients who were not responding to conventional treatments. All the patients will be treated with 0.1% tacrolimus suspension two times daily, LE/T eye drops four times daily for 1 month. Additionally, 0.1% olopatadine two times daily and preservative-free artificial tears four times daily will be used. After the first month, LE/T will be stopped, with other treatments continued for the last 5 months. Visual acuity and intraocular pressure (IOP) will be measured at enrollment and 1, 2, 3 and 6 months after treatment. Besides, 6 subjective symptoms and 6 clinical signs will be graded at each visit based on a 4-point scale. The primary endpoints are the change in symptoms and objective signs. Treatment failure will be recorded if extra corticosteroids were required.

Completed

Looking for future studies?

Notify Me

Key information

Age range

5 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • vernal keratoconjunctivitis patients resistant to conventional treatments

Exclusion criteria

  • Patients diagnosed with other coexisting eye disease; with a confirmed or possible pregnancy; younger than 5 years old; had presence of systemic diseases other than coexisting allergic rhinitis, asthma, and atopic dermatitis; reported hypersensitivity to tacrolimus

Treatment and study plan

Tacrolimus

Drug

All the patients will be treated with 0.1% tacrolimus suspension two times daily, LE/T eye drops four times daily for 1 month. 0.1% tacrolimus will be continued for the last 5 months.

Other names: loteprednol etabonate 0.5%/tobramycin 0.3% (LE/T)

Primary outcomes

  1. the change of objective ocular signs

    Time frame: before treatment and 1, 2, 3 and 6 months after treatment

    doctors judge the change of conjunctival injection, conjunctival edema, papillae, cobblestone papillae, limbal inflammation and corneal epithelial staining

Secondary outcomes

  1. the change of Best corrected visual acuity

    Time frame: before treatment and 1, 2, 3 and 6 months after treatment

    doctors measure the change of BCVA

  2. the change of intraocular pressure

    Time frame: before treatment and 1, 2, 3 and 6 months after treatment

    doctors measure the change of BCVA

  3. the change of subjective ocular symptoms

    Time frame: before treatment and 1, 2, 3 and 6 months after treatment

    patients report the change of itching, redness, burning, photophobia, grittiness, and mucus discharge

Sponsors and collaborators

Lead sponsor

Zhongshan Ophthalmic Center, Sun Yat-sen University

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 14, 2018
Registry last updated
Mar 14, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.