Evaluation of the efficacy and safety of Vismed® eyedrop for the treatment of moderate to severe ocular dryness
- Conditions
- Moderate to severe dry eye/meibomian glands dysfunction (MGD)Eye DiseasesOther disorders of lacrimal gland
- Registration Number
- ISRCTN40779210
- Lead Sponsor
- aboratoires Horus Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
There are no requirements as to participant race, gender or occupation
1. Age: more than 18 years
2. Subject with a moderate to severe dry eye syndrome needing artificial tears in the 3 months preceding the inclusion
3. Subject having used only artificial tears without preservative (NaCl 0.9%, Hydrabak®) during 1 to 2 weeks before inclusion (up to 6 times a day)
4. Subject with a score = 6 for the 5-Item Dry Eye Questionnaire (DEQ-5)
5. Subject with at least one eye with:
5.1. Global ocular staining (cornea and conjunctiva) =4 and =9 (Oxford scale from 0 to 15)
AND one the following criteria:
5.2. Schirmer test = 3mm/5 min and =9mm/ 5 min
OR
5.3. Sum of 3 measurements of Tear film Break-Up Time (TBUT) = 30s
6. Have read and understood the Participant Information Sheet
7. Have read, signed and dated the Informed Consent
8. Able to comply with the study requirements, willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study. The following are specific criteria that exclude a candidate from enrolment in this study:
1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate participation in the study
2 Use of systemic or ocular medications (isotretinoïd, cyclosporine, tacrolimus, sirolimus, pimecrolimus, punctual plugs) that would contraindicate participation in the study as determined by the investigator
3. Distance Best corrected visual acuity <1/10
4. Severe ocular dryness with one of these conditions:
4.1. Eyelid or blinking malfunction
4.2. Corneal disorders not related to dry eye syndrome
4.3. Ocular metaplasia
4.4. Filamentous keratitis
4.5. Corneal neovascularization
5. Had ocular surgery, including laser surgery, in either eye within the last 6 months
6. Wearing contact lenses during the study
7. Received ocular therapy (either eye) with any ophthalmic medication, except tear substitutes, within 2 weeks prior to study start or expected to receive ocular therapy during the study
8. Known pregnancy or lactation during the study period
9. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals
10. Participation in any clinical trial within 30 days of the enrollment visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ocular surface integrity; cornea and conjunctiva staining (Oxford score) on the worse eye between D0 and D35 (Visit 2 and Visit 3)
- Secondary Outcome Measures
Name Time Method <br> Comparison of D35 versus D0 and D84 versus D0 progression for test and control eyedrop and comparison between test and control eyedrop for the following parameters:<br> 1. Cornea and conjunctiva staining (Oxford score) on worse eye<br> 2. DEQ-5 score (5-Items Dry Eye Questionnaire)<br> 3. Lissamine green staining score in worse eye<br> 4. Schirmer test (tear volume) result in worse eye<br> 5. Tear film Break-Up Time (TBUT in seconds) in worse eye<br> 6. Ocular dryness severity symptoms (0 to 10 scale) and total score of all symptoms<br>