Efficacy and Tolerance of Nova22007 Versus Vehicle in Patients With Vernal Keratoconjunctivitis (VKC)

NCT00328653 | Completed Phase 2 Results

• 1 other identifier: NOVATIVE - NVG05L101
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is:

• To assess the efficacy of Nova22007, a cyclosporine A (CsA), 0.05% and 0.1% versus vehicle in patients with vernal keratoconjunctivitis (VKC) after a 4-week treatment period. The secondary objectives of this study are:
• To compare the safety and ocular tolerance of Nova22007 0.05% and 0.1%;
• To assess the long term safety and ocular tolerance of Nova22007 0.05% and 0.1%; and
• To assess the decrease in frequency of concomitant artificial tears use.

Conditions

Conjunctivitis, Vernal

Keywords

vernal keratoconjunctivitis (VKC), eye, allergy, cyclosporin

Outcome Measures

Primary Outcomes (2)

• Overall Rating of Subjective Symptoms of VKC in Period I

  The primary criteria of the trial was the overall rating of subjective symptoms in ocular symptoms of VKC as compared to Baseline and assessed at Week 4 (Month 1) based on a five-point scale based on BenEzra trial (BenEzra 1986): 1. = Overall worsening of the subjective findings. 2. = No change in the symptoms. 3. = Slight improvement with the child still unable to participate in all normal daily activities. 4. = Marked improvement despite temporary mild itching or mucus discharge. 5. = Completely free of all symptoms.

  Week 4

• Overall Rating of Objective Symptoms of VKC in Period I

  Overall rating of objective signs was to be assessed under the slit lamp by the Investigator and recorded on a five-point scale based on BenEzra trial (BenEzra 1986): 1. Intense congestion of conjunctival vessels, perilimbal injection, or corneal involvement with the papillary proliferations more extensive or similar to the situation recorded before treatment in at least one of the eyes. 2. The overall condition was assessed as better than before treatment in both eyes. 3. Total re-epithelialisation of the cornea although slight conjunctival and perilimbal hyperaemia and papillary proliferations remains in both eyes. 4. Only slight conjunctival hyperaemia without perilimbal injection or papillary proliferations in at least one eye 5. Both eyes were quiet with no papillary proliferations or conjunctival or perilimbal injection.

  Week 4

Secondary Outcomes (2)

• Change in Mean Daily Number of Unpreserved Artificial Tears Instillations in Period I

  Up to Month1

• Ocular Tolerance in Period I

  Up to Month1

Study Arms (3)

NOVA22007 0.05%

EXPERIMENTAL

four times daily

Drug: Cyclosporine NOVA22007 0.05%

NOVA22007 0.1%

EXPERIMENTAL

four times daily

Drug: Cyclosporine NOVA22007 0.1%

Vehicle

SHAM COMPARATOR

administered four times daily

Drug: Vehicle

Interventions

Cyclosporine NOVA22007 0.05% DRUG

NOVA22007 0.05%

Cyclosporine NOVA22007 0.1% DRUG

NOVA22007 0.1%

Vehicle DRUG

Vehicle

Eligibility Criteria

• Age: 4 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• At least the two following signs, in at least one eye\* (the same eye should fulfill both criteria):
• Presence of giant papillae with a diameter ≥ 1 mm on the upper tarsal conjunctiva AND
• Superficial keratitis
• At least two 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.
• Hyperemia score equal to or greater than 2.

You may not qualify if:

• Concomitant corneal ulcer of infectious origin.
• Active ocular herpes
• Disease that could possibly interfere with the interpretation of the study 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 study.
• Active herpes.
• History of malignancy or a recurrence in the last 5 years.
• Abnormality of nasolacrimal drainage apparatus.
• Concomitant disease not stabilized within 1 month before Screening Visit (e.g. diabetes with glycemia out of range, trouble with thyroid secretions, etc.) or judged by the investigator to be incompatible with the study (e.g. current systemic infections), or condition incompatible with the frequent assessments needed by the study.
• Known hypersensitivity to one of the components of the investigational medicinal products (IMP) or test products.
• Severe systemic allergy requiring systemic treatment at study entry.
• Female of childbearing potential.
• History of drug or alcohol addiction (\> 50g/day, 5 glasses alcohol/day).

Sponsors & Collaborators

• Santen SAS: lead

Study Sites (1)

Groupe Hospitalier Bichat-Claude Bernard

Paris, 75018, France

Location

Related Publications (1)

• Leonardi A, Pisella PJ, Benitez-Del-Castillo JM, Amrane M, Ismail D, Doan S, Bremond-Gignac D. NOVATIVE: A Phase II/III, Multicenter, Double-masked, Randomized Study of Cyclosporine A 0.05% and 0.1% Ophthalmic Cationic Emulsion Versus Vehicle in Patients with Vernal Keratoconjunctivitis. Clin Ther. 2023 Dec;45(12):1284-1288. doi: 10.1016/j.clinthera.2023.09.022. Epub 2023 Oct 21.

  PMID: 37872059 DERIVED

MeSH Terms

Conditions

Conjunctivitis, Allergic; Hypersensitivity

Condition Hierarchy (Ancestors)

Conjunctivitis; Conjunctival Diseases; Eye Diseases; Hypersensitivity, Immediate; Immune System Diseases

Results Point of Contact

• Title: R&D Quality Manager
• Organization: Santen Inc

evelyn.chikere@santen.com

415 268 9199

Study Officials

• David BenEzra, Pf

  Haddassah University Hospital

  PRINCIPAL INVESTIGATOR

• Christophe Baudouin, Pf.

  Hôpital des XV-XX 28 rue de Charenton 75012 Paris

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 19, 2006
• First Posted: May 22, 2006
• Study Start: May 1, 2006
• Primary Completion: February 22, 2007
• Last Updated: December 14, 2021
• Results First Posted: December 14, 2021

Record last verified: 2021-11

Locations

FR (1)