Topical Immuonosuppressant Drugs in Spring Catarrh

Not Applicable

• Conditions: Vernal Keratoconjunctivitis
• Interventions: Drug: Prednisolone (as Acetate); Drug: CycloSPORINE Ophthalmic Suspension; Drug: LTacrolimus Topical

• Registration Number: NCT04705584
• Lead Sponsor: Assiut University

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.

Study Timeline

• Status Verified: 2021-01
• Study Start: 2021-01
• Study First Submitted: 2021-01-10
• Study First Submitted QC: 2021-01-10
• Last Update Submitted: 2021-01-10
• Study First Posted: 2021-01-12
• Last Update Posted: 2021-01-12
• Primary Completion: 2021-10
• Study Completion: 2022-02

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 180

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Topical steroids	Prednisolone (as Acetate)	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 Cyclosporine A	CycloSPORINE Ophthalmic Suspension	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 Tacrolimus	LTacrolimus Topical	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.

Primary Outcome Measures

Name	Time	Method
Ocular surface changes	8 weeks	Changes in papillary conjunctival reaction, conjunctival redness, Tranta spots and gelatinous masses

Secondary Outcome Measures

Name	Time	Method
Ocular symptoms changes	8 weeks	Change of ocular symptoms as documented by the patient as redness, itching and discharge
Intraocular pressure changes	8 weeks	Mean change of intraocular pressure from baseline
Ocular surface toxicity	8 weeks	Development of corneal or conjunctival toxic effects as corneal epithelial defects or chronic conjunctival follicular reaction

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt