Topical Immuonosuppressant Drugs in Spring Catarrh

Vernal Keratoconjunctivitis Clinical Trial

Official title:

Role of Topical Immuonosuppressant in the Management of Spring Catarrh: a Comparative Study Between Cyclosporine A 2% and Tacrolimus 0.3%

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04705584
• Other study ID #: 17101246
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2021
• Est. completion date: February 2022

Study information

• Verified date: January 2021
• Source: Assiut University
• Contact: Zeiad H Eldaly, MD
• Phone: 002-0109-4544-721
• Email: dr_ziadeldaly[@]aun.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: February 2022
• Est. primary completion date: October 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Common Cold
• Conjunctivitis, Allergic
• Keratoconjunctivitis
• Vernal Keratoconjunctivitis

Intervention

Drug:
• Prednisolone (as Acetate)
Standard treatment protocol includes Topical steroids for 8 weeks with gradual dose tapering.
• CycloSPORINE Ophthalmic Suspension
This treatment arm includes the use of topical cyclosporine A after 2 weeks of topical steroid use.
• LTacrolimus Topical
This treatment arm includes the use of topical Tacrolimus after 2 weeks of topical steroid use.

Locations

Country	Name	City	State
Egypt	Assiut University Hospital	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ocular surface changes	Changes in papillary conjunctival reaction, conjunctival redness, Tranta spots and gelatinous masses	8 weeks
Secondary	Ocular symptoms changes	Change of ocular symptoms as documented by the patient as redness, itching and discharge	8 weeks
Secondary	Intraocular pressure changes	Mean change of intraocular pressure from baseline	8 weeks
Secondary	Ocular surface toxicity	Development of corneal or conjunctival toxic effects as corneal epithelial defects or chronic conjunctival follicular reaction	8 weeks