One cohort Study To Assess the duration of the improvement following NOVA22007 Treatment Discontinuation in Improved Patients With Severe Dry Eye Disease.

• Conditions: Severe Dry Eye Disease; MedDRA version: 14.1Level: LLTClassification code 10023350Term: Keratoconjunctivitis siccaSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10013778Term: Dry eyesSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: LLTClassification code 10013777Term: Dry eye syndromeSystem Organ Class: 10015919 - Eye disorders; MedDRA version: 14.1Level: PTClassification code 10013774Term: Dry eyeSystem Organ Class: 10015919 - Eye disorders; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2012-002066-12-GB
• Lead Sponsor: OVAGALI Pharma S.A.S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-10-29
• Last Update Posted: 4 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

1. Patient completed the main study (NVG10E117).
2. Patient was treated with NOVA22007 during the last 6 months.
3. Patient must provide written informed consent for the extension study.
4. Patient must be willing and able to undergo and return for scheduled study-related examinations
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 65
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 65

Exclusion Criteria

Patients will not be eligible for inclusion in the extension study if one of the following criteria is met:
1. Drop out from the main study (NVG10E117).
2. Completion of last visit Month 12 of the main study (NVG10E117) more than 2 weeks ago.
3. Resistance to treatment. A patient is considered treatment resistant at Month 12 if at Month 9 and 12 visits CFS score was at grade 4 or 5. (The patient is not treatment resistant and consequently eligible if at Month 12 visit the grade was 4 or more but at Month 9 visit the grade was 3 or less).
4. Active herpes Keratitis or history of ocular herpes. 5. Active ocular infection (viral, bacterial, fungal, protozoal). 6. Presence or history of any systemic or ocular disorder, condition ordisease that could possibly interfere with the conduct of the required study procedures or the interpretation of study results or judged by the investigator to be incompatible with the study.
7. Women of childbearing potential not using a medically acceptable, highly effective method of birth control (such as hormonal implants, injectable or oral contraceptives together with condoms, some intrauterine devices, sexual abstinence or vasectomized partner) throughout the conduct of the study treatment periods and up to 2 weeks after the study end. Post-menopausal women (two years without menstruation) do not need to use any method of birth control.
8. Current participation in another clinical trial than the main study.

Study & Design

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