Oral supplementation of omega-3 and omega-6 in dry eye syndrome

Completed

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

• Registration Number: ISRCTN17233445
• Lead Sponsor: aboratoire Chauvin, Bausch & Lomb Inc. (France)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-11-28
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 140

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)

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified