Evaluation of eyelid cleansing wipes for dry eye management
- Conditions
- Eye DiseasesDry eye/meibomian glands dysfunction (MGD)
- Registration Number
- ISRCTN18065902
- Lead Sponsor
- aboratoires Horus Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 33
1. There are no requirements as to participant race or occupation
2. At least 18 years old
3. Have read and understood the Participant Information Sheet
4. Have read, signed and dated the Informed Consent
5. Dry eye sufferers defined by an OSDI symptom score >13
6. Abnormal eyelid margin defined by:
6.1. Meibomian gland dysfunction (MGD) identified by a positive MGD score of Grade 2 or higher; and/or
6.2. Anterior blepharitis identified by eyelash contamination
7. Best corrected visual acuity of at least 20/30 in each eye
8. Have normal eyes with the exception of the need for visual correction
9. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule
1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate study participation
2. Use of systemic or ocular medications that could be contraindicated as determined by the investigator
3. Monocular participants (only one eye with functional vision)
4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit
5. History of herpetic keratitis, ocular surgery or irregular cornea
6. Known pregnancy or lactation during the study period
7. 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
8. Participation in any clinical trial within 30 days of the enrolment visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method