Topical Tacrolimus in Vernal Keratoconjunctivitis
Primary Purpose
Vernal Keratoconjunctivitis
Status
Unknown status
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Topical tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Vernal Keratoconjunctivitis
Eligibility Criteria
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
Sites / Locations
- The Eye CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Topical tacrolimus
Placebo
Arm Description
20 eyes with active Vernal Keratoconjunctivitis
20 eyes with active Vernal Keratoconjunctivitis
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT02456025
First Posted
August 18, 2013
Last Updated
November 22, 2015
Sponsor
The Eye Center and The Eye Foundation for Research in Ophthalmology
1. Study Identification
Unique Protocol Identification Number
NCT02456025
Brief Title
Topical Tacrolimus in Vernal Keratoconjunctivitis
Official Title
Topical Tacrolimus in Vernal Keratoconjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Eye Center and The Eye Foundation for Research in Ophthalmology
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vernal Keratoconjunctivitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Topical tacrolimus
Arm Type
Active Comparator
Arm Description
20 eyes with active Vernal Keratoconjunctivitis
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
20 eyes with active Vernal Keratoconjunctivitis
Intervention Type
Drug
Intervention Name(s)
Topical tacrolimus
Other Intervention Name(s)
Tacrolimus eye drops
Intervention Description
Topical tacrolimus 0.01% twice daily for one month
Primary Outcome Measure Information:
Title
The efficacy of Topical Tacrolimus in Vernal Keratoconjunctivitis
Description
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
Time Frame
Five months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Samir S Shoughy
Phone
0096614649614
Email
samir.shawki@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Khalid F Tabbara
Phone
0096614649614
Email
k.tabbara@nesma.net.sa
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Samir S Shoughy
Organizational Affiliation
THE EYE CENTER
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Eye Center
City
Riyadh
Country
Saudi Arabia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Samir S Shoughy
Phone
0096614649614
Email
samir.shawki@hotmail.com
First Name & Middle Initial & Last Name & Degree
Khalid F Tabbara
Phone
0096614649614
Email
k.tabbara@nesma.net.sa
First Name & Middle Initial & Last Name & Degree
Samir S Shoughy
12. IPD Sharing Statement
Learn more about this trial
Topical Tacrolimus in Vernal Keratoconjunctivitis
We'll reach out to this number within 24 hrs