A one month study of the efficacy and safety of SVS20 versus carbomer and saline in patients with bilateral moderate dry eye syndrome: a randomised, double blind, controlled, parallel group, pilot, phase II study

Completed

• Conditions: Dry eye syndrome; Eye Diseases; Disorders of lacrimal system

• Registration Number: ISRCTN06098697
• Lead Sponsor: TRB Chemedica International SA (Switzerland)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-13
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. Signed informed consent
2. Male and female patients aged 18 years and over
3. Patients with at least a three-month documented history of bilateral moderate dry eye due to Sjogren's syndrome (immune exocrinopathy) or diagnosed as a primary syndrome
4. Patients with total score of staining with lissamine green of at least 5/12 and not more than 10/12 for each eye
5. Patients with at least two symptoms of dry eye among soreness, scratchiness, dryness, grittiness and burning each:
5.1. Occurring at least often and
5.2. Rated at least 30 mm and not more than 70 mm on the 0 to 100 mm visual analogue scale (VAS)
6. Patients with at least two out of three following objective parameters:
6.1. Schirmer test less than or equal to 10 mm wetting/5 minutes for each eye
6.2. Tear film break-up time (BUT) less than or equal to 10 seconds for each eye
6.3. Staining with fluorescein with a total score greater than or equal to 3/7 for each eye
7. Eligible patients using the following medications should have been taking them continuously for the two months before the screening visit and the dose should not have changed during the whole trial:
7.1. Tricyclic antidepressive agents
7.2. Anti-histaminic agents
7.3. Phenothiazines
7.4. Cholinergic agents
7.5. Antimuscarinic agents
7.6. Non-steroidal anti-inflammatory drugs (NSAIDs)
7.7. Beta-blockers
7.8. Immunomodulators
7.9. Anti-acneic agents
7.10. Diuretic agents
8. Female patients should be post-menopausal or be using a recognised, reliable method of contraception for at least three months before selection
9. Patients complying with the local regulations (e.g. social security system)

Exclusion Criteria

1. Patients who respond to Unilarm® during or at the end of the run-in period so that their inclusion criteria are not met at D0 examinations
2. Patients with unilateral dry eye
3. Severe dry eye syndrome, defined as:
3.1. Staining with fluorescein with a depth score less than 3 in any eye and/or
3.2. Severe bulbar conjunctival hyperaemia (score of 4) in any eye and/or
3.3. Severe limbal hyperaemia (score of 4) in any eye and/or
3.4. Severe palpebral observation (score of 4) in any eye and/or
3.5. Severe blepharitis in any eye
4. Patients who underwent:
4.1. Refractive surgery within the last 12 months before selection and/or
4.2. Any other ocular surgery or ocular trauma within the last four months before selection
5. Patients taking the following systemic concomitant medications within the last two months before selection:
5.1. Corticosteroids and/or
5.2. Tetracyclines
6. Patients requiring concomitant in-eye medication for the whole trial, except Unilarm® during the selection period only
7. Patients with abnormality of the nasolacrimal drainage apparatus
8. Patient with permanent occlusion of lacrimal puncta in any eye
9. Patient with temporary punctal plug within two months before selection in any eye
10. Patients with 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)
11. Patients who participated in any other clinical trial within the last 30 days before selection
12. Patients with known hypersensitivity to hyaluronic acid or any component or procedure used in the study
13. Patients who need or intend to wear contact lens during the whole trial
14. Patients with best corrected visual acuity (BCVA) less than 1/10 in any eye
15. Pregnant or lactating females
16. Known human immunodeficiency virus (HIV) positive patients, if they belong to an anamnestic known risk group like drug addicts, etc., or if there is any reasonable doubt about HIV a validated test must be performed
17. Patients with a concomitant diagnosis of sarcoidosis, non-hodgkin lymphoma, bone marrow transplant or any secondary Sjogren's syndrome due to rheumatoid diseases or as an adverse event possibly of any other prior of concomitant medication

Study & Design

• Study Type: Interventional
• Study Design: Not specified