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.
| ISRCTN | ISRCTN91412460 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN91412460 |
| Secondary identifying numbers | SVS20-EUR-06-01 |
- Submission date
- 01/06/2007
- Registration date
- 13/06/2007
- Last edited
- 02/05/2014
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Christophe Baudouin
Scientific
Scientific
Service dOphtalmologie
Hôpital des Quinze-Vingts
28, Rue de Charenton
Paris
75012
France
Study information
| 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 |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | 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. |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 15/10/2007 |
| Completion date | 28/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 300 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/10/2007 |
| Date of final enrolment | 28/02/2009 |
Locations
Countries of recruitment
- France
- United Kingdom
Study participating centre
Service dOphtalmologie
Paris
75012
France
75012
France
Sponsor information
TRB Chemedica International SA (Switzerland)
Industry
Industry
c/o Dr Nabila Ibnou-Zekri
12 Rue Michel-Servet
Geneva
1211
Switzerland
| Website | http://www.trbchemedica.com/ |
|---|---|
"ROR" |
https://ror.org/012pz6314 |
Funders
Funder type
Industry
TRB Chemedica International SA (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2012 | Yes | No |
