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Topical Immuonosuppressant Drugs in Spring Catarrh

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04705584
Enrollment
180
Registered
2021-01-12
Start date
2021-01-31
Completion date
2022-02-28
Last updated
2021-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Vernal Keratoconjunctivitis

Keywords

Resistant spring catarrh, Cyclosporine A, Tacrolimus

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.

Interventions

DRUGPrednisolone (as Acetate)

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

DRUGCycloSPORINE Ophthalmic Suspension

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

DRUGLTacrolimus Topical

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

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
3 Years to 18 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Ocular surface changes8 weeksChanges in papillary conjunctival reaction, conjunctival redness, Tranta spots and gelatinous masses

Secondary

MeasureTime frameDescription
Ocular symptoms changes8 weeksChange of ocular symptoms as documented by the patient as redness, itching and discharge
Intraocular pressure changes8 weeksMean change of intraocular pressure from baseline
Ocular surface toxicity8 weeksDevelopment of corneal or conjunctival toxic effects as corneal epithelial defects or chronic conjunctival follicular reaction

Countries

Egypt

Contacts

Primary ContactZeiad H Eldaly, MD
dr_ziadeldaly@aun.edu.eg002-0109-4544-721

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026