NCT04705584

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
180

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 12, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

9 months

First QC Date

January 10, 2021

Last Update Submit

January 10, 2021

Conditions

Vernal Keratoconjunctivitis

Keywords

Resistant spring catarrhCyclosporine ATacrolimus

Outcome Measures

Primary Outcomes (1)

  • Ocular surface changes

    Changes in papillary conjunctival reaction, conjunctival redness, Tranta spots and gelatinous masses

    8 weeks

Secondary Outcomes (3)

  • Ocular symptoms changes

    8 weeks

  • Intraocular pressure changes

    8 weeks

  • Ocular surface toxicity

    8 weeks

Study Arms (3)

Topical steroids

ACTIVE COMPARATOR

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)

Topical Cyclosporine A

EXPERIMENTAL

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

Topical Tacrolimus

EXPERIMENTAL

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

Interventions

Prednisolone (as Acetate)DRUG

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

Also known as: Predforte Eye drops
Topical steroids
CycloSPORINE Ophthalmic SuspensionDRUG

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

Topical Cyclosporine A
LTacrolimus TopicalDRUG

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

Topical Tacrolimus

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients suffering from Vernal Keratoconjunctivitis refractory to conventional treatments (Topical Anti-histaminic agents, Mast-cell stabilizer and steroids) are included.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71516, Egypt

Location

MeSH Terms

Conditions

Conjunctivitis, Allergic

Interventions

Prednisolone

Condition Hierarchy (Ancestors)

ConjunctivitisConjunctival DiseasesEye DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Central Study Contacts

Zeiad H Eldaly, MD

CONTACT

002-0109-4544-721dr_ziadeldaly@aun.edu.eg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Ophthalmology

Study Record Dates

First Submitted

January 10, 2021

First Posted

January 12, 2021

Study Start

January 1, 2021

Primary Completion

October 1, 2021

Study Completion

February 1, 2022

Last Updated

January 12, 2021

Record last verified: 2021-01

Locations

EG(1)