Topical Immuonosuppressant Drugs in Spring Catarrh

Status Not yet recruiting

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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04705584
Study type	Interventional
Source	Assiut University
Contact	Zeiad H Eldaly, MD
Phone	002-0109-4544-721
Email	dr_ziadeldaly@aun.edu.eg
Status	Not yet recruiting
Phase	N/A
Start date	January 2021
Completion date	February 2022

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05076084` - Evaluation of the Efficacy and Safety of Tacrolimus Drops in Children With Vernal Keratoconjunctivitis
Recruiting	`NCT02057822` - Cytokine Assay in Tears of Healthy Children and With Vernal Keratoconjunctivitis: Case Control Study and Monitoring of Cases at 6 Months	N/A
Completed	`NCT03464435` - A Novel Combined Therapy for Refractory Vernal Keratoconjunctivitis	Phase 4
Completed	`NCT00445120` - Lactobacillus Rhamnosus GG Oral Treatment Efficacy on Vernal Keratoconjunctivitis Treatment	Phase 2/Phase 3
Recruiting	`NCT03557203` - Dermatologic Tacrolimus Ointment on Eyelids in the Treatment of Refractory Vernal Keratoconjunctivitis and Atopic Keratoconjunctivitis
Completed	`NCT01211327` - Topical Cyclosporine for Vernal Keratoconjunctivitis (VKC) in Rwanda	Phase 4
Completed	`NCT05353101` - Cyclosporine 0.05% Eye Drops for Vernal Keratoconjunctivitis Trial	Phase 1
Completed	`NCT03379311` - A Study of AK002 in Patients With Atopic Keratoconjunctivitis, Vernal Keratoconjunctivitis, and Perennial Allergic Conjunctivitis	Phase 1
Completed	`NCT00426023` - Cyclosporin A Eye Drop Treatment in Vernal Keratoconjunctivitis	Phase 3
Completed	`NCT01751126` - Double-Masked Trial of NOVA22007 (1mg/mL Ciclosporin/Cyclosporine) Versus Vehicle in Pediatric Patients With Active Severe Vernal Keratoconjunctivitis	Phase 3
Recruiting	`NCT02456025` - Topical Tacrolimus in Vernal Keratoconjunctivitis	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.