Oral supplementation of omega-3 and omega-6 in dry eye syndrome
| ISRCTN | ISRCTN17233445 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17233445 |
| Secondary identifying numbers | Study #425 |
- Submission date
- 23/10/2008
- Registration date
- 28/11/2008
- Last edited
- 02/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Catherine Creuzot-Garcher
Scientific
Scientific
Hôpital Général
Service d'Ophtalmologie
3 Rue du Faubourg Raines
BP 1519
Dijon
21034
France
Study information
| Study design | Randomised, double-masked, two-armed, parallel group, placebo-controlled, multicentre study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | A three-month, multicentre, double-masked, randomised, controlled, clinical study to investigate the efficacy of Medilar™ in patients suffering from dry eye syndrome |
| Study objectives | Oral supplementation of omega-3 and omega-6 can reduce inflammatory markers in conjunctival cells of patients suffering from dry eye syndrome. |
| Ethics approval(s) | Italy: 1. Ethics Committee of the San Martino University Hospital (Azienda Ospedaliera Universitaria San Martino) gave approval on the 17th February 2006 (ref: 0016378/06) 2. Ethics Committee of the University Polyclinic (Azienda Policlinico Universitario) gave approval on the 12th January 2006 (ref: E 625/05) France: 1. Ethics Committee CCPPRB de Bourgogne gave approval on the 29th September 2005 (ref: 2005/20) |
| Health condition(s) or problem(s) studied | Dry eye syndrome |
| Intervention | Test product - Medilar™: Oral supplementation with 855 mg of omega-3 and 15 mg of omega-6, vitamins (C,E, B6, B12) and zinc per day (3 capsules per day) for 3 months. Comparator: Placebo (medium chain triglycerides), 3 capsules per day for 3 months. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Omega-3, omega-6 (Medilar™) |
| Primary outcome measure | Percentage of conjunctival epithelial cells expressing human leukocyte antigen DR-1 (HLA-DR) inflammatory markers in the worst eye, measured at baseline and month 3. |
| Secondary outcome measures | Efficacy (in worst eye): 1. Global subjective dry eye score (foreign body sensation, dryness, burning, stinging, photophobia) 2. Subjective dry eye score for each symptom 3. Objective dry eye score for each test (fluorescein staining of the cornea, Van Bijsterveld test, tear Break-Up Time [BUT] test, Schirmer-I) 4. Fluorescence intensity of conjunctival cells expressing HLA-DR inflammatory marker 5. Quality of life questionnaire for ocular surface disease Safety: 6. Adverse or unexpected events All secondary outcomes were assessed at baseline (D0), week 6 and month 3. |
| Overall study start date | 22/11/2005 |
| Completion date | 18/01/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 140 |
| Key inclusion criteria | 1. Legally adult outpatients, both males and females 2. Having given their written informed consent 3. Suffering from dry eye syndrome as defined by the presence of: 3.1. At least two of the following four objective tests corresponding to the scores below: 3.1.1. Schirmer-I-values less than 10 mm/5 min 3.1.2. Break-up-time-values less than 10 sec 3.1.3. Fluorescein staining of the cornea score greater than or equal to 1 and less than 4 3.1.5. Van Bijsterveld score greater than or equal to 3 and less than or equal to 6 (Lissamine green) 3.2. A score of at least 1, for at least two of the five following subjective tests (scored 0 to 3): 3.2.1. Foreign body sensation 3.2.2. Dryness 3.2.3. Burning 3.2.4. Stinging 3.2.5. Photophobia 4. Stable systemic treatment (unchanged for one month or longer) |
| Key exclusion criteria | 1. Aged less than 18 years 2. Severe dry eye (Lissamine green greater than 6 or corneal staining greater than or equal to 4) 3. Uncontrolled evolutive systemic disease 4. Patients with an implantable cardioverter defibrillator (ICD) 5. Uncontrolled inflammatory disease (treated with varying doses of steroids or non-steroidal anti-inflammatory substances) 6. Change in systemic treatment within the last month 7. Expected change in treatment of concomitant disease 8. Patients treated with anticoagulants or predisposed to bleeding or haemorrhage 9. Drastic change of food and/or food supplements within the last month 10. Other food supplement with eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) 11. Patients with a history of recurrent ocular herpes and/or recurrent uveitis 12. Evidence of acute ocular infection and/or intra-ocular inflammation within one month prior to the onset of this study 13. Patients who have undergone ocular surgery within the last 6 months 14. Change in ocular treatment within the last month 15. Patients currently using any ophthalmic medication including any ocular ointment except artificial tear preparation and eye cleaning solution for treatment of dry eye syndrome 16. Patients treated with topical ocular, steroidal or non-steroidal anti-inflammatory treatment within the last month 17. Patients treated with ocular topical cyclosporin within the last month 18. Occlusion therapy with lacrimal or punctum plugs within the last 3 months 19. Patients currently wearing contact lenses 20. Pregnant or lactating women 21. Women of childbearing potential considering becoming pregnant during the course of the study and those not taking precautions to avoid pregnancy 22. Patients for whom, in the physician's opinion, any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study 23. Patients who are unlikely to comply with the study protocol or who are likely to be moving and lost to follow-up in the study period 24. Known contraindication, adverse reaction, or hypersensitivity to any constituents of this food supplement 25. Patients who have participated in any clinical investigation within the last 30 days or are currently participating in a clinical study 26. Patients who are addicted to alcohol or drugs 27. Patients with neurotic, psychiatric disorders or suicidal tendencies 28. Patients who plan to start a diet or to change their diet during the course of the study |
| Date of first enrolment | 22/11/2005 |
| Date of final enrolment | 18/01/2007 |
Locations
Countries of recruitment
- France
- Italy
Study participating centre
Hôpital Général
Dijon
21034
France
21034
France
Sponsor information
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
Industry
Industry
416, rue Samuel Morse
CS 99535
Montpellier cedex 2
34961
France
| Website | http://www.bausch.fr |
|---|---|
"ROR" |
https://ror.org/018qejt38 |
Funders
Funder type
Hospital/treatment centre
Laboratoire Chauvin, Bausch & Lomb Inc. (France)
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 |
