Twelve-Month Results of Cyclosporine A

Cationic Emulsion in a Randomized Study

in Patients With Pediatric Vernal
Keratoconjunctivitis
1st year resident Byambadorj. M
Vernal keratoconjunctivitis

• Spring and fall

• Palpebral and limbal
• Itching and photosensitivity
• Type I and type IV hypersensitivity
• Commonly affects males in the first 2 decades of life

Giant papillae Horner-Trantas dots Shield ulcer

Patients

CsA controls:

• IL-2 production
• Effects of mediators
• Inhibiting Th2 proliferation
• Immune cell number increases
Introduction
Introduction

Authors:
DOMINIQUE BREMOND-GIGNAC, SERGE DOAN, MOURAD
AMRANE, DAHLIA ISMAIL, JESU´S MONTERO, JA´NOS NE
´METH, PASQUALE ARAGONA, AND ANDREA LEONARDI

Published online:
November 23, 2019

American Journal of Ophthalmology:

April, 2020, Volume 212, P116-126
Materials and Methods

• Prospective, multicenter,
randomized, double-masked,
vehicle-controlled, parallel-
arm, phase 3 study

• April 2013 – February 2016

• 51 sites in 11 countries
Patients

Inclusion criteria:

• 4 to <18 years

• Had experienced ≥1 recurrence previous year

• VKC grade 3 or 4 (Bonini scale)

• Grade 4 or 5 corneal fluorescein staining (CFS; modified Oxford scale)

• Mean VAS ≥ 60mm (photophobia, tearing, itching, and mucous discharge)

Assessments
Assessments
Assessments
Patients

Exclusion criteria:

• Topical or systemic corticosteroids (within 1 week)

• Topical or systemic immunosuppressive (within 90 days)

• Scraping of the vernal plaque (within 1 month)

• Other ocular surgery (within 6 months)

• Presence or history of severe systemic allergy

Patients
Patients
Overall

• Age: 4-17 years (9.1) • Time since diagnosis: 3.1–3.6

• Sex: Male(77.5%) > Female(22.5%) • VKC grade: 3(61.3%) > 4(38.7%)

• Race: White(70.4%) > Asian > Black > Other • CFS score: 4(88.0% > 5(12%)

• Form: Mixed(63.4%) > Tarsal > Limbal • Asthma: 17.6%

• Type: Perennial > Seasonal (except CsA CE

QID)
Patients
Patients
CsA CE 1 drop QID (57)
• Lack of efficacy (1)
• AE (2)
Period l (0-4 months) • Patient decision unrelated to
AE (2)
• Patient non-compliance (1)
• Adverse event (1)
Period ll (4-12 months)
• Lack of efficacy 11
• Patient decision unrelated to AE 7
Total • Adverse effect 4
• Patient non-compliance 2
• Lost to follow up 1
• Other 1
CsA CE 1 drop BID (55) Vehicle 1 drop QID (57)
• Lack of efficacy (5) • Lack of efficacy (5)
• Lost to follow-up (1) • AE (2)
• Patient decision unrelated to • Patient decision unrelated to
AE (3) AE (2)
• Patient non-compliance (1)
• Other (1)
• Lack of efficacy (1)
• Lost to follow-up (1)
• Patient decision unrelated to
AE (3)
Patients
CsA CE 1 drop QID (57)
• Lack of efficacy (1)
• AE (2)
Period l (0-4 months) • Patient decision unrelated to
AE (2)
• Patient non-compliance (1)
• Adverse event (1)
Period ll (4-12 months)
• Lack of efficacy 11
• Patient decision unrelated to AE 7
Total • Adverse effect 4
• Patient non-compliance 2
• Lost to follow up 1
• Other 1
CsA CE 1 drop BID (55) Vehicle 1 drop QID (57)
• Lack of efficacy (5) • Lack of efficacy (5)
• Lost to follow-up (1) • AE (2)
• Patient decision unrelated to • Patient decision unrelated to
AE (3) AE (2)
• Patient non-compliance (1)
• Other (1)
• Lack of efficacy (1)
• Lost to follow-up (1)
• Patient decision unrelated to
AE (3)
Safety

Rescue medication:

• CFS score worsening by ≥1grade • Dexamethasone 0.1% QID up to 5 days

1. Evaluation period – Maximum of 2 courses
• VAS ≥10mm 2. Follow-up period – Maximum 4 courses

• Artificial tears allowed

Safety & Efficacy

Follow-up period: Efficacy assessment:

• BCDVA and IOP • CFS score

• Blood samples: • Use of RT

CsA levels, serum creatinine, alanine
aminotransferase, aspartate aminotransferase • Occurrence of corneal ulceration

• Slit lamp examination • VAS score

1. Anterior chamber inflammation
2. Lens opacification • QoL over the preceding 2-week period

Overall effect of the medication:

0 (unsatisfactory) to 3 (very satisfactory)
Results
Results
Results
Results
 • CsA CE effective in improving keratitis, symptoms

• QoL in patients with severe VKC – QID most effective dosing

Conclusion • CFS, symptoms and QoL score remained stable over 12 months
Medication-related TEAEs reported for 15 patients (20.8%) in QID
and 11 patients (15.7%) in BID group

• Reduction in rescue dexamethasone usage

Discussion
Thank you for your
attention
Thank you for your
attention