Topical Immuonosuppressant Drugs in Spring Catarrh

Sponsor

Assiut University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT04705584

Collaborator

(none)

180

Enrollment

Location

Arms

Anticipated Duration (Months)

13.8

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Vernal Keratoconjunctivitis	Drug: Prednisolone (as Acetate) Drug: CycloSPORINE Ophthalmic Suspension Drug: LTacrolimus Topical	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

180 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2021

Anticipated Primary Completion Date :

Oct 1, 2021

Anticipated Study Completion Date :

Feb 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Prednisolone (as Acetate) Standard treatment protocol includes Topical steroids for 8 weeks with gradual dose tapering. Other Names: Predforte Eye drops
Experimental: 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.	Drug: CycloSPORINE Ophthalmic Suspension This treatment arm includes the use of topical cyclosporine A after 2 weeks of topical steroid use.
Experimental: 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.	Drug: LTacrolimus Topical This treatment arm includes the use of topical Tacrolimus after 2 weeks of topical steroid use.

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Prednisolone (as Acetate)

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

Other Names:

Predforte Eye drops

Experimental: 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.

Drug: CycloSPORINE Ophthalmic Suspension

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

Experimental: 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.

Drug: LTacrolimus Topical

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

Outcome Measures

Primary Outcome Measures

Ocular surface changes [8 weeks]
Changes in papillary conjunctival reaction, conjunctival redness, Tranta spots and gelatinous masses

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Years to 18 Years

Sexes Eligible for Study:

All

Accepts 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.