Effect of IKERVIS® eye drops administrated once daily on the quality of vision in dry eye disease patients with severe keratitis.

Phase 1

• Conditions: Effect of one eye drop of IKERVIS®on adult male or female (aged 18 years or above) Dry Eye Disease patients with severe keratitis despite the use of tear substitutes.; MedDRA version: 19.1 Level: PT Classification code 10023332 Term: Keratitis System Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-003497-40-FR
• Lead Sponsor: SANTEN SAS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-01-10
• Last Update Posted: 10 December 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 33

Inclusion Criteria

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

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 17
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 16

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified