Randomized comparison between two dry eye treatments
- Conditions
- Ocular dryness associated with meibomian gland dysfunctionEye Diseases
- Registration Number
- ISRCTN15276264
- Lead Sponsor
- Eurofins (France)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 120
1. Sex: male or female.
2. Age: 18 years and more.
3. Presenting dry eye symptoms for at least 6 months.
4. OSDI (Ocular Surface Disease Index) = 18
5. At least one eye eligible with:
5.1. sum of peripheral corneal and conjunctival staining = 4 and = 9 (Oxford 0-15 grading scheme) AND
5.2. sum of 3 measurements of Tear film Break-Up Time (TBUT) = 15s
6. Meibomian Gland Dysfunction on at least one eye (same eye eligible) with a score of 1 or higher for meibum quality score (from 0: clear to 3: toothpaste/obstruction) and evidence of partial or whole missing Meibomian Glands.
7. Ability and willingness to apply eyelid hygiene during the whole study, including wash-out period.
8. Having given freely and expressly his/her informed consent.
9. Able to comply with the study requirements, as defined in the present CIP, at the Investigator’s appreciation.
10. In France: subject being affiliated to a health social security system.
11. Female subjects of childbearing potential should use a medically accepted contraceptive regimen since at least 12 weeks before the beginning of the study, during all the study and at least 1 month after the study end.
1. Pregnant or nursing woman or planning a pregnancy during the study.
2. Subject deprived of freedom by administrative or legal decision.
3. Subject in a social or health institution
4. Subject who is under guardianship or who is not able to express his/her consent.
5. Use of contact lenses in either eye during the study.
6. Far best-corrected visual acuity = 1/10.
7. Subject with severe ocular dryness with one of these conditions:
7.1. Eyelid or blinking malfunction
7.2. Corneal disorders not related to dry eye syndrome
7.3. Ocular metaplasia
7.4. Filamentous keratitis
7.5. Corneal neovascularization
8. History of ocular traumatism, ocular infection or ocular inflammation within the last 3 months.
9. History of ocular allergy or ocular herpes within the last 12 months.
10. Subjects who underwent ocular surgery, including laser surgery, in either eye within the last 6 months.
11. Any troubles of the ocular surface not related to dry eye syndrome.
12. Use of the following ocular treatments: isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus during the month preceding the inclusion.
13. IOP > 21 mmHg
14. Uncontrolled systemic disease
15. Alcohol abuse
16. Psychiatric disorders
17. Cognitive impairment that could affect evaluation of preferences or inability to understand written patient information
18. Participation in other clinical studies in the last month
19. Hypersensitivity to one or more components of the study product
20. Dry eye due to systemic disease, concomitant medication, malign conditions or idiopathic causes
21. Punctual plugs during the past 3 months
22. Use of lipid-containing eye drops during the past 3 months
23. Use of other therapeutic ophthalmics during the past 3 months
24. Earlier participation at this clinical trial or the patient being an investigator or a member of the personnel involved at this clinical trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ocular dryness is measured in terms of Tear film Break-Up Time (TBUT) in seconds at all four visits (baseline, and approximately 7 days, 5 weeks, 14 weeks)
- Secondary Outcome Measures
Name Time Method 1. Cornea and conjunctiva staining score (Oxford score) measuring using lissamine green staining at all four visits. <br>2. Meibomian gland expression measured using a rating score from 1-3 at all four visits<br>3. Subjective expression of dryness measured using an OSDI questionnaire at all four visits. <br>4. Global performance of the study product measured by the investigator and participant on a four point scale from unsatisfactory to very satisfactory at the third and fourth visits.