Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis

NCT03237936 | Completed Phase 4 Results

• 1 other identifier: NVG16E128
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed 3-month study is a prospective, open-label, multicentre, phase IV, proof of concept study. The study is designed to assess the effect on the quality of vision of IKERVIS® (1mg/mL ciclosporin) eye drops administered once daily in dry eye disease (DED) patients with severe keratitis, as well as its safety and efficacy.

Conditions

Keratitis

Outcome Measures

Primary Outcomes (1)

• Correlation Between the Change From Baseline in VMR Measured With FVA System at Month 3 and the Change From Baseline in the CFS at Month 3.

  Spearman's coefficient of correlation will be calculated at Month 3 between the change from baseline of Corneal Fluorescein Staining (CFS) and respectively the change from baseline of Visual Maintenance Ratio (VRM).

  at month 3

Study Arms (1)

IKERVIS® (1mg/mL ciclosporin) eye drops

EXPERIMENTAL

one drop of study medication (IKERVIS®1mg/mL) once daily in each eye at bedtime during 3 months.

Drug: 1mg/mL ciclosporin

Interventions

1mg/mL ciclosporin DRUG

IKERVIS® (1mg/ml ciclosporin) eye drops administered once daily following 3 months of treatment

Also known as: IKERVIS®

IKERVIS® (1mg/mL ciclosporin) eye drops

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient eligibility is determined according to the following criteria:
• In the opinion of the investigator, the patient is capable of understanding and complying with protocol requirements.
• The patient signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures
• Male or female patient is aged 18 years or above.
• DED patients with persistent severe keratitis at the Screening and
• Baseline Visits defined as the following:
• CFS score of 3, 4 or 5 on the modified Oxford scale
• Patient must be willing and able to undergo and return for scheduled study-related examinations.
• The same eye (eligible eye) should fulfill all the above criteria.

You may not qualify if:

• Patients with history of ocular trauma or ocular infection (viral, bacterial, fungal, protozoal) within 90 days before the Screening Visit and any ocular diseases other than dry eye disease requiring topical ocular treatment during the course of the study.

Sponsors & Collaborators

• Santen SAS: lead

Study Sites (1)

CHU de Brest

Brest, France

Location

MeSH Terms

Conditions

Keratitis

Interventions

Cyclosporine

Condition Hierarchy (Ancestors)

Corneal Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Cyclosporins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Results Point of Contact

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

evelyn.chikere@santen.com

4152689199

Study Officials

• Pierre-Jean PISELLA

  CHU Bretonneau

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: August 3, 2017
• Study Start: March 28, 2017
• Primary Completion: July 11, 2018
• Study Completion: July 11, 2018
• Last Updated: April 18, 2024
• Results First Posted: April 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)