A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial.

• Register: EUCTR
• Last refreshed on: 25 November 2019
• Main ID: EUCTR2007-001708-19-GB
• Date of registration: 01/08/2007
• Prospective Registration: Yes
• Primary sponsor: TRB CHEMEDICA INTERNATIONAL SA
• Public title: A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial.
• Scientific title: A 3-month study of the efficacy and safety of SVS20 in patients with bilateral moderate dry eye syndrome : A prospective, double-masked, randomised, controlled, parallel-group, 3-arm, multicentre, phase III trial.
• Date of first enrolment: 21/02/2008
• Target sample size: 300
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001708-19
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes; Randomised: yes; Open: no; Single blind: no; Double blind: yes; Parallel group: yes; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: yes; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

France, United Kingdom

Key inclusion & exclusion criteria

Inclusion criteria:
1. Signed informed consent,
2. Male and female patients aged between 18 and 80 years,
3. With at least a 3-month documented history of moderate dry eye due to Sjögren’s syndrome (immune exocrinopathy) or diagnosed as a primary syndrome before the selection visit,
4. With at least 2 symptoms of dry eye among soreness, scratchiness, dryness, grittiness and burning each:
· Occurring at least often and
· Rated at least 30 mm and not more than 70 mm on the 0 to 100 mm VAS,
5. With moderate dry eye defined as at least 3 out of the 4 following objective parameters:
· Reduced tear volume : Schirmer test = 10 mm wetting/5min for each eye,
· Tear film instability : BUT = 10 seconds for each eye,
· Staining with fluorescein with a total score (type + extent) of >= 3/7 for each eye,
· Staining with lissamine green with total score (nasal + corneal conjunctiva + temporal conjunctiva) of at least 3/12 for each eye
6. If the patient is taking the following medications that influence tear production, he/she should have taken these products continuously for the last 2 months before the selection visit and the dose must not change during the whole trial:
· Tricyclic antidepressive agents,
· Anti-histaminic agents,
· Phenothiazines,
· Cholinergic agents,
· Anti-muscarinic agents,
· NSAIDs,
· Beta-blockers,
· Immunomodulators,
· Anti-acneic agents and
· Diuretic agents.
7. Female patients should be post-menopausal or be using recognised, reliable methods of contraception for at least 3 months before the selection visit.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion criteria:
1. Patients with unilateral dry eye.
2. Severe dry eye syndrome, defined as:
· Staining with fluorescein with a depth score >= 3 in any eye and / or
· Severe bulbar conjunctival hyperaemia (score of 4) in any eye and / or
· Severe limbal hyperaemia (score of 4) in any eye and / or
· Severe palpebral observation (score of 4) in any eye and / or
· Severe anterior or posterior blepharitis in any eye.
3. Patients who underwent:
· Refractive surgery within the last 12 months before selection and / or
· Any other ocular surgery or ocular trauma within the last 4 months before selection.
4. Patients taking the following systemic concomitant medications:
· Corticosteroids within 2 months before selection and for the whole trial and / or
· Tetracyclines within 1 month before selection and for the whole trial.
5. Patients using in-eye cyclosporine within the last 4 weeks prior to selection (D-16 to D-7) and for the whole trial.
6. Patients requiring concomitant in-eye medication for the whole trial, except Unilarm® during the selection period only,
7. Abnormality of the nasolacrimal drainage apparatus.
8. Patient with permanent occlusion of lacrimal puncta in any eye.
9. Use of temporary punctal plug in any eye within 2 months before the selection visit.
10. Other diseases or characteristics judged by the investigator to be incompatible with the frequent assessments needed in this study or with reliable instillation of the products (for example: mental or physical incapacity, language comprehension, geographical localisation, etc…).
11. Known hypersensitivity to hyaluronic acid or any component or procedure used in the study.
12. Patients who participated in any other clinical trial within the last 30 days before selection,
13. Patients that need or intend to wear contact lens during the whole trial,
14. Patients with BCVA < 1/10 in any eye,
15. Pregnant or lactating females.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

treatment on bilateral moderate dry eye syndrome due to Sjögren's syndrome or diagnosed as a primary syndrome
MedDRA version: 9.1 Level: LLT Classification code 10013774 Term: Dry eye

Intervention(s)

Product Name: SVS20
Product Code: SVS20
Pharmaceutical Form: Eye drops, solution

Trade Name: carbomer
Pharmaceutical Form: Eye gel

Trade Name: 0.9% sodium chloride
Pharmaceutical Form: Eye drops, solution

Primary Outcome(s)

Secondary Objective: Secondary objectives will be to assess whether SVS20:
· Is superior to saline and equivalent to or greater than the carbomer for the efficacy parameters: symptom intensity, impact of symptoms on daily life activities, BUT, corneal staining with fluorescein, staining with lissamine green, Schirmer test, average number of daily instillations and global evaluation of efficacy,
· Is equivalent to or greater than saline and carbomer for the safety parameters: BCVA, comfort of the eye drops (presence and duration of blurred vision upon instillation), examination of ocular adnexa and adverse events reporting.

Main Objective: The primary objective will be to confirm that, as shown in the previous studies SVS20-99-04 and SVS20-HUN-05-01, the frequency of moderate dry eye symptoms will be significantly improved (greater decrease in the change from baseline values) in the SVS20 group compared to the saline group and equivalent to or greater than the carbomer group.

Primary end point(s): The primary efficacy endpoint will be the difference between groups for the change from baseline at D28 in symptom frequency (summed scores for soreness + scratchiness + dryness + grittiness + burning each rated on a 0–3 scale; maximum total score 15).

Secondary ID(s)

CCT-NAPN-16588

SVS20-EUR-06-01

Ethics review

Status: Approved
Approval date:
Contact: