Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SVS20-EUR-06-01
Study information
Scientific title
Acronym
Study hypothesis
The aim of this study is to assess the efficacy and safety of SVS20 vs saline and carbomer in patients with bilateral moderate dry eye syndrome due to Sjögrens syndrome (immune exocrinopathy) or diagnosed as a primary syndrome.
Ethics approval
Ethics approval received from:
1. France: CPP 8 Ile de France on the 09/07/2007 (ref: 07 06 39). Amendments performed on 28/09/2007 and 12/03/2008.
2. France: AFFSAPS (MoH) on the 23/08/2007 (ref: A70459-55). Amendments performed on 18/04/2008.
3. UK: South East Research Ethics Committee on the 12/09/2007 (ref: 07/H1102/86). Amendments performed on 18/10/2007 and 03/04/2008.
4. UK: MHRA on the 24/07/2007 (ref: 31838/0001/001-0001 and -0002). Amendments performed on 22/04/2008.
Study design
Prospective, double-masked, randomised, controlled, parallel-group, 3 arm, multicentre, phase III trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Bilateral moderate dry eye syndrome / ophthalmology
Intervention
Patients will be asked to instill SVS20 (an eyedrop; active ingredient: Sodium Hyaluronate [SH]) or saline plus carbomer 2-4 times per day of for 3 months.
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measures
Symptom frequency at baseline, 1 month, 2 and 3 months.
Secondary outcome measures
The following will be assessed at baseline, 1 month, 2 and 3 months:
1. General ophthalmic examinations
2. Break-Up Time (BUT) of the tear film
3. Tear production assessed by the Schirmer test
4. Clinical state of the ocular surface assessed by fluorescein and lissamine staining
5. Symptom intensity
6. Presence and duration of blurred vision upon instillation and global evaluation
Overall trial start date
15/10/2007
Overall trial end date
28/02/2009
Reason abandoned
Eligibility
Participant inclusion criteria
1. Signed informed consent
2. Male and female patients aged 18 years and over
3. With at least a 3-month documented history of moderate dry eye due to Sjögrens syndrome 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:
4.1. At least occurring often and
4.2. Rated at least 30 mm and not more than 70 mm on the 0 to 100 mm Visual Analogue Scale (VAS)
5. Moderate dry eye defined as at least 3 out of the 4 following objective parameters:
5.1. Reduced tear volume: Schirmer test ≤ 10 mm wetting/5 min for each eye
5.2. Tear film instability: Break-Up Time (BUT) ≤ 10 seconds for each eye
5.3. 3/7 for each staining with fluorescein with a total score (type + extent) of eye
5.4. Patient with total score (nasal + corneal conjunctiva + temporal conjunctiva) of staining with lissamine green of at least 3/12 for each eye
6. If the patient takes the following medications that influence tear production, he/she should have taken these products continuously for 2 months before the selection visit and dose will not change during the whole trial:
6.1. Tricyclic antidepressive agents
6.2. Anti-histaminic agents
6.3. Phenothiazines
6.4. Cholinergic agents
6.5. Anti-muscarinic agents
6.6. Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
6.7. Beta-blockers
6.9. Immunomodulators
6.10. Anti-acneic agents and
6. 11. Diuretic agents
7. Female patients should be post-menopausal or be using recognised, reliable methods of contraception for at last 3 months before the selection visit
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
1. Patients with unilateral dry eye
2. Severe dry eye syndrome, defined as:
2.1. Staining with fluorescein with a depth score greater or equal to 3 and / or
2.2. Severe bulbar conjunctival hyperaemia (score of 4) and / or
2.3. Severe limbal hyperaemia (score of 4) and / or
2.4. Severe palpebral observation (score of 4) and / or
2.5. Severe anterior or posterior blepharitis
2.6. 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
3. Patients taking the following systemic concomitant medications within 2 months before selection and for the whole trial:
3.1. Corticosteroids and/or
3.2. Tetracyclines
4. Patients taking cyclosporine within the 4 weeks prior to screening (between 16 to 7 days prior to intervention) through the duration of the treatment period
5. Patients requiring concomitant in-eye medication for the whole trial, except Unilarm® during the selection period only
6. Abnormality of the nasolacrimal drainage apparatus
7. Patient with permanent occlusion of lacrimal puncta in any eye
8. Use of temporary punctal plug within 2 months before the selection visit in any eye
9. 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 disability of the upper limbs)
10. Known hypersensitivity to hyaluronic acid or any component or procedure used in the study
11. Patients who participated in any other clinical trial within the last 30 days before selection
12. Patients who need or intend to wear contact lens during the whole trial
13. Patients with Best-Corrected Visual Acuity (BCVA) < 1/10 in any eye
14. Pregnant or lactating females
Recruitment start date
15/10/2007
Recruitment end date
28/02/2009
Locations
Countries of recruitment
France, United Kingdom
Trial participating centre
Service dOphtalmologie
Paris
75012
France
Sponsor information
Organisation
TRB Chemedica International SA (Switzerland)
Sponsor details
c/o Dr Nabila Ibnou-Zekri
12 Rue Michel-Servet
Geneva
1211
Switzerland
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
TRB Chemedica International SA (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22483761
Publication citations
-
Results
Baeyens V, Bron A, Baudouin C, , Efficacy of 0.18% hypotonic sodium hyaluronate ophthalmic solution in the treatment of signs and symptoms of dry eye disease., J Fr Ophtalmol, 2012, 35, 6, 412-419, doi: 10.1016/j.jfo.2011.07.017.