Table 1.

Inclusion/exclusion criteria of the two clinical trials.

NOVATIVE	VEKTIS
Inclusion	Inclusion
• ≥4 years of age • Active VKC (acute or chronic) needing treatment • ≥2 following signs, in at least one eye:   ○ Presence of giant papillae with a diameter ≥1 mm on the upper tarsal conjunctiva and superficial keratitis • ≥2 of the following ocular symptoms with a score >2 in at least one eye: burning/stinging, tearing, itching, pain, sticky eyelids, foreign body sensation, mucus discharge, and photophobia • Hyperaemia score ≥2 • Informed consent	• 4 to <18 years of age • Active severe VKC* with severe keratitis† • ≥1 recurrence of VKC during the previous year • Mean score of ≥60 mm on a 0–100-mm VAS for the 4 main VKC symptoms (photophobia, tearing, itching, and mucous discharge) • Informed consent
Exclusion	Exclusion
• Concomitant corneal ulcer of infectious origin • Active herpes • Disease that could possibly interfere with the interpretation of the trial results: active uveitis (defined by Tyndall score >0), previous history of ocular hypertension or glaucoma, or condition incompatible with the frequent assessments needed by the trial • History of malignancy or a recurrence in the last 5 years • Abnormality of nasolacrimal drainage apparatus • Concomitant disease not stabilised within 1 month before screening visit or incompatible with the trial • Severe systemic allergy requiring systemic treatment at trial entry • Female of childbearing potential • History of drug or alcohol addiction • Use of prohibited concomitant medications	• Ocular anomalies other than VKC affecting the ocular surface • Abnormalities of lid anatomic features, nasolacrimal drainage, or blinking function • Active ocular infection or history of ocular herpes, varicella zoster or vaccinia virus infection; or any ocular disease that would require topical ocular treatment during the study • Presence or history of severe systemic allergy • Topical or systemic corticosteroids within 1 week; topical CsA, tacrolimus, or sirolimus or any systemic immunosuppressive drug within 90 days before enrolment • Scraping of the vernal plaque within 1 month; or any other ocular surgery within 6 months prior to baseline visit

CFS corneal fluorescein staining, CsA cyclosporine, VAS visual analogue scale, VKC vernal keratoconjunctivitis.

*Grade 3 or 4 on the Bonini scale.

^†CFS score of Grade 4 or 5 on the modified Oxford scale.