Dry Eye
Conditions
Brief summary
MAF-1217 is meant as the medical device which is to be effective in most forms of DED; therefore, it is expected that study patients benefit from study participation, and can reduce the signs and symptoms of surgery induced DED in patients undergoing cataract surgery, in a TID application pre-surgery.
Detailed description
This is a multicentre, pre-market, open label, randomized, prospective study exploring the performance of MAF-1217 when administered pre-surgery, in reducing the sign and symptoms of post-surgery DED in patients undergoing cataract surgery. Patients will be enrolled 2 weeks before Surgery (screening visit), will undergo cataract surgery (Day 0 - Baseline/Surgery), and then will be seen at week 1 and 2 after surgery.
Interventions
DEVICEMAF-1217
Patients will be enrolled at screening (2 weeks before surgery), then will be randomized with a 1:1 ratio to 2 groups of 23 patients each: A. patients receiving MAF-1217 B. patients receiving just standard antibiotic therapy
Sponsors
VISUfarma SpA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. At least 18 years old patients, male and female 2. Patients without diagnosed DED (including subclinical DED) or with mild DED, with BUT \>7 3. Normal to mild DED according to OSDI chart 4. Diagnosis of Cataract requiring surgery 5. Wishing to participate in the study and able to sign the ICF 6. Shirmer test \> 15 mm /5' 7. No topic ophthalmic medication, including lubricating eyedrops administration for at least 4 days before screening visit.
Exclusion criteria
1. Neuropathic causes of dry eye (diabetes, long-standing contact lens wearing, previous ocular herpes infections) 2. Patients with diagnosis of Glaucoma 3. Functional and anatomic eyelid abnormalities, 4. Complicated cataract, 5. Suture affixing during surgery, 6. Use of artificial tears in the month preceding the study visit 7. Coexisting corneal diseases 8. Autoimmune diseases 9. Past or active cicatricial conjunctivitis 10. Past ocular surface burns 11. Keratinization of the eyelid margin 12. Sjogren syndrome 13. History of corneal trauma 14. Pregnant and lactating women 15. Younger than 18 years old patients 16. Inability to self-administer study medications 17. Known allergic sensitivity to any of the devices ingredients, or any other type of allergy 18. Participation in a clinical trial during the 3 months prior to the beginning of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| break-up time (BUT) | 1 month | Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in break-up time (BUT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| osmolarity | 1 month | Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in osmolarity |
| OSDI score | 1 month | Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in OSDI score. The OSDI is assessed on a scale of 0 to 100, with higher scores representing greater disability. The index demonstrates sensitivity and specificity in distinguishing between normal subjects and patients with dry eye disease. |
| Schirmer test I | 1 month | Difference in the change (with respect to the baseline/surgery visit, V0) in the two arms occurred in Schirmer test I (test uses paper strips inserted into the eye for several minutes to measure the production of tears) |
Countries
Italy
Outcome results
None listed