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Topical Immuonosuppressant Drugs in Spring Catarrh

Primary Purpose

Vernal Keratoconjunctivitis

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Prednisolone (as Acetate)
CycloSPORINE Ophthalmic Suspension
LTacrolimus Topical
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vernal Keratoconjunctivitis focused on measuring Resistant spring catarrh, Cyclosporine A, Tacrolimus

Eligibility Criteria

3 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients suffering from Vernal Keratoconjunctivitis refractory to conventional treatments (Topical Anti-histaminic agents, Mast-cell stabilizer and steroids) are included.

Exclusion Criteria:

  • Contact lens wearer. Patient with one functioning eye. Patients with any other active ocular inflammatory conditions. Patients with hypersentivity reaction to either Cyclosporine A or Tacrolimus. Loss of 2 or more follow up visits.

Sites / Locations

  • Assiut University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Topical steroids

Topical Cyclosporine A

Topical Tacrolimus

Arm Description

Topical Prednisolone acetate 1.0% Topical eye drops 4 times per day for 2 weeks followed by 4 times daily for 2 weeks, then twice daily for 2 weeks and finally once daily for 2 weeks.

Topical Prednisolone acetate 1.0% Topical eye drops 4 times per day for 2 weeks followed by Topical Cyclosporine A 2% Topical eye drops 2 times per day for 6 weeks.

Topical Prednisolone acetate 1.0% Topical eye drops 4 times per day for 2 weeks followed by Topical Tacrolimus A 0.3% Topical eye drops 2 times per day for 6 weeks.

Outcomes

Primary Outcome Measures

Ocular surface changes
Changes in papillary conjunctival reaction, conjunctival redness, Tranta spots and gelatinous masses

Secondary Outcome Measures

Ocular symptoms changes
Change of ocular symptoms as documented by the patient as redness, itching and discharge
Intraocular pressure changes
Mean change of intraocular pressure from baseline
Ocular surface toxicity
Development of corneal or conjunctival toxic effects as corneal epithelial defects or chronic conjunctival follicular reaction

Full Information

First Posted
January 10, 2021
Last Updated
January 10, 2021
Sponsor
Assiut University
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1. Study Identification

Unique Protocol Identification Number
NCT04705584
Brief Title
Topical Immuonosuppressant Drugs in Spring Catarrh
Official Title
Role of Topical Immuonosuppressant in the Management of Spring Catarrh: a Comparative Study Between Cyclosporine A 2% and Tacrolimus 0.3%
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
October 2021 (Anticipated)
Study Completion Date
February 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Spring catarrh is a prevalent type of conjunctival allergic disorder in temperate countries. Topical steroids are the cornerstone management of spring catarrh beside other anti allergic drugs. However, prolonged use of topical steroids especqially in resistant spring catarrh carries risk of ocular side effects as 2nd glaucoma and cataract. We will investigate the safety and efficacy of topical immuonosuppressant in the management of resistant spring catarrh as an alternative to steroid therapy.
Detailed Description
Vernal keratoconjunctivitis (VKC) (spring catarrh) is an allergic disease that affects children and young adults and is one of the most severe forms of atopic ocular disease. Classically, the incidence of VKC peaks in the summer and spring. However, 60% of cases can become chronic with persistent symptoms. VKC is mainly characterized by intense itching, but patients also frequently complain of lacrimation, foreign body sensation and photophobia. There are three different clinical forms of VKC; the palpebral form, which is characterized by giant papillae in the upper tarsal; the limbal form, with gelatinous nodules composed of eosinophilic infiltrates and degenerated epithelial cells (Horner- Tantra spots) and a mixed form. The treatment of VKC involves the use of topical Anti-histaminic and Mast Cell Stabilizers, which are usually sufficient to control symptoms in mild cases. However, a high number of patients are refractory to allergy therapy and require treatment with topical steroids. Side effects related to long-term steroid use, such as increased intraocular pressure (IOP), cataract development and increased susceptibility to infections. Refractory VKC, development of steroid complications or the need for long-term use of Topical steroids are indications to use Topical immune-suppressant drugs as Tacrolimus (TCL) or Cyclosporine A (CsA). Tacrolimus is an immunosuppressant derived from Streptomyces tsukubaensis, is an alternative to steroid therapy for allergic diseases of the ocular surface. Topical Cyclosporine A is a fungal metabolite that reduces ocular inflammation by inhibiting Th2 lymphocyte proliferation and histamine release from mast cells and basophils.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vernal Keratoconjunctivitis
Keywords
Resistant spring catarrh, Cyclosporine A, Tacrolimus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical steroids
Arm Type
Active Comparator
Arm Description
Topical Prednisolone acetate 1.0% Topical eye drops 4 times per day for 2 weeks followed by 4 times daily for 2 weeks, then twice daily for 2 weeks and finally once daily for 2 weeks.
Arm Title
Topical Cyclosporine A
Arm Type
Experimental
Arm Description
Topical Prednisolone acetate 1.0% Topical eye drops 4 times per day for 2 weeks followed by Topical Cyclosporine A 2% Topical eye drops 2 times per day for 6 weeks.
Arm Title
Topical Tacrolimus
Arm Type
Experimental
Arm Description
Topical Prednisolone acetate 1.0% Topical eye drops 4 times per day for 2 weeks followed by Topical Tacrolimus A 0.3% Topical eye drops 2 times per day for 6 weeks.
Intervention Type
Drug
Intervention Name(s)
Prednisolone (as Acetate)
Other Intervention Name(s)
Predforte Eye drops
Intervention Description
Standard treatment protocol includes Topical steroids for 8 weeks with gradual dose tapering.
Intervention Type
Drug
Intervention Name(s)
CycloSPORINE Ophthalmic Suspension
Intervention Description
This treatment arm includes the use of topical cyclosporine A after 2 weeks of topical steroid use.
Intervention Type
Drug
Intervention Name(s)
LTacrolimus Topical
Intervention Description
This treatment arm includes the use of topical Tacrolimus after 2 weeks of topical steroid use.
Primary Outcome Measure Information:
Title
Ocular surface changes
Description
Changes in papillary conjunctival reaction, conjunctival redness, Tranta spots and gelatinous masses
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Ocular symptoms changes
Description
Change of ocular symptoms as documented by the patient as redness, itching and discharge
Time Frame
8 weeks
Title
Intraocular pressure changes
Description
Mean change of intraocular pressure from baseline
Time Frame
8 weeks
Title
Ocular surface toxicity
Description
Development of corneal or conjunctival toxic effects as corneal epithelial defects or chronic conjunctival follicular reaction
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients suffering from Vernal Keratoconjunctivitis refractory to conventional treatments (Topical Anti-histaminic agents, Mast-cell stabilizer and steroids) are included. Exclusion Criteria: Contact lens wearer. Patient with one functioning eye. Patients with any other active ocular inflammatory conditions. Patients with hypersentivity reaction to either Cyclosporine A or Tacrolimus. Loss of 2 or more follow up visits.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zeiad H Eldaly, MD
Phone
002-0109-4544-721
Email
dr_ziadeldaly@aun.edu.eg
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71516
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zeiad H Eldaly
Phone
002-0109-4544-722
Email
dr_ziadeldaly@aun.edu.eg

12. IPD Sharing Statement

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Topical Immuonosuppressant Drugs in Spring Catarrh

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