NCT02456025

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2013

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 18, 2013

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

May 28, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

November 24, 2015

Status Verified

November 1, 2015

Enrollment Period

3.7 years

First QC Date

August 18, 2013

Last Update Submit

November 22, 2015

Conditions

Vernal Keratoconjunctivitis

Outcome Measures

Primary Outcomes (1)

  • 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

    Five months

Study Arms (2)

Topical tacrolimus

ACTIVE COMPARATOR

20 eyes with active Vernal Keratoconjunctivitis

Drug: Topical tacrolimus

Placebo

PLACEBO COMPARATOR

20 eyes with active Vernal Keratoconjunctivitis

Drug: Topical tacrolimus

Interventions

Topical tacrolimusDRUG

Topical tacrolimus 0.01% twice daily for one month

Also known as: Tacrolimus eye drops
PlaceboTopical tacrolimus

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Eye Center

Riyadh, Saudi Arabia

RECRUITING

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Tacrolimus

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

MacrolidesLactonesOrganic Chemicals

Study Officials

  • Samir S Shoughy

    THE EYE CENTER

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Samir S Shoughy

CONTACT

0096614649614samir.shawki@hotmail.com

Khalid F Tabbara

CONTACT

0096614649614k.tabbara@nesma.net.sa

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ophthalmologist

Study Record Dates

First Submitted

August 18, 2013

First Posted

May 28, 2015

Study Start

April 1, 2013

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

November 24, 2015

Record last verified: 2015-11

Locations

SA(1)