ISRCTN17233445CompletedNot Applicable
A three-month, multicentre, double-masked, randomised, controlled, clinical study to investigate the efficacy of Medilar™ in patients suffering from dry eye syndrome
aboratoire Chauvin, Bausch & Lomb Inc. (France)0 sites140 target enrollmentStarted: November 28, 2008Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 140
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
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
Investigators
Similar Trials
Active, not recruiting
Phase 1
A clinical study of OPT-302 with ranibizumab compared to ranibizumab alone in patients with neovascular age-related macular degeneratioEUCTR2020-004736-24-HUOpthea Limited990
Active, not recruiting
Phase 1
A clinical study of OPT-302 with aflibercept compared to aflibercept alone in patients with neovascular age-related macular degeneratioEUCTR2020-004694-46-BGOpthea Limited990
Active, not recruiting
Phase 1
A clinical study of OPT-302 with aflibercept compared to aflibercept alone in patients with neovascular age-related macular degeneratioeovascular Age-related Macular Degeneration (wet AMD)MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 27.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2020-004694-46-DEOpthea Limited990
Active, not recruiting
Phase 1
A clinical study of OPT-302 with ranibizumab compared to ranibizumab alone in patients with neovascular age-related macular degeneratioeovascular age-related macular degeneration (wet AMD)MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2020-004736-24-BGOpthea Limited990
Active, not recruiting
Phase 1
A clinical study of OPT-302 with aflibercept compared to aflibercept alone in patients with neovascular age-related macular degeneratioeovascular Age-related Macular Degeneration (wet AMD)MedDRA version: 20.0Level: SOCClassification code 10015919Term: Eye disordersSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.0Level: PTClassification code 10071129Term: Neovascular age-related macular degenerationSystem Organ Class: 10015919 - Eye disordersMedDRA version: 20.1Level: LLTClassification code 10067791Term: Wet macular degenerationSystem Organ Class: 10015919 - Eye disordersEUCTR2020-004694-46-ESOpthea990