Topical Immuonosuppressant Drugs in Spring Catarrh

NCT ID: NCT04705584

Last Updated: 2021-01-12

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-31
• Study Completion Date: 2022-02-28

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.

Conditions

Vernal Keratoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Topical steroids

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.

Group Type: ACTIVE_COMPARATOR

Prednisolone (as Acetate)

Intervention Type: DRUG

Standard treatment protocol includes Topical steroids for 8 weeks with gradual dose tapering.

Topical Cyclosporine A

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.

Group Type: EXPERIMENTAL

CycloSPORINE Ophthalmic Suspension

Intervention Type: DRUG

This treatment arm includes the use of topical cyclosporine A after 2 weeks of topical steroid use.

Topical Tacrolimus

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.

Group Type: EXPERIMENTAL

LTacrolimus Topical

Intervention Type: DRUG

This treatment arm includes the use of topical Tacrolimus after 2 weeks of topical steroid use.

Interventions

Prednisolone (as Acetate)

Standard treatment protocol includes Topical steroids for 8 weeks with gradual dose tapering.

Intervention Type: DRUG

CycloSPORINE Ophthalmic Suspension

This treatment arm includes the use of topical cyclosporine A after 2 weeks of topical steroid use.

Intervention Type: DRUG

LTacrolimus Topical

This treatment arm includes the use of topical Tacrolimus after 2 weeks of topical steroid use.

Intervention Type: DRUG

Other Intervention Names

Predforte Eye drops

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.

• Minimum Eligible Age: 3 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Zeiad Eldalyl

Lecturer of Ophthalmology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Assiut University Hospital

Asyut, , Egypt

Countries

Egypt

Central Contacts

Zeiad H Eldaly, MD

Role: CONTACT

dr_ziadeldaly@aun.edu.eg

002-0109-4544-721

Facility Contacts

Zeiad H Eldaly

Role: primary

dr_ziadeldaly@aun.edu.eg

002-0109-4544-722

Other Identifiers

17101246

Identifier Type: -

Identifier Source: org_study_id