Evaporative Dry Eye Disease
Conditions
Keywords
Dry Eye Disease, Lubricant eye drops, Meibomian Gland Dysfunction, Evaporative dry eye
Brief summary
A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye
Detailed description
Pilot, randomized, double-blind, prospective, non-inferiority study to demonstrate the safety and efficacy of I-DROP MGD vs two commercially available preservative-free lubricant eye drops for the management of evaporative dry eye
Interventions
DEVICEI-DROP MGD
All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30
DEVICETheloze Duo
All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30
DEVICESystane Complete PF
All drops are to be used for 28-30 days, twice daily with assessment done at Day 0, 30 minutes post-installation at day 0, day 7 and day 28/30
Sponsors
I-MED Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
All products will have their label removed and placed a white sticker showing the group (A or B or C). Products with be put in a white box with the letter indicated on it.
Intervention model description
in vivo, human patient with confirmed Evaporative dry eye disease
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Is at least 18 years of age and has full legal capacity to volunteer. * Has read and signed an information consent form. * Is willing and able to follow instructions and maintain the appointment schedule. * Has dry eye disease as per the TFOS DEWS II definition with a clear moderate to severe evaporative Dry Eye: * OSDI ≥ 13 * And TBUT \< 10 seconds * And \>5 spots of corneal fluorescein staining OR \> 9 conjunctival spots * Meibomian Gland score of 1 or higher using NEI grading criteria.
Exclusion criteria
* Is participating in any concurrent clinical or research study. * Is wears contact lenses. * Is using any systemic medications that could impact the aqueous tear layer, including antihistamines, vitamin A analogues, phenothiazines, anti-anxiety drugs, antidepressants, and other medications with anticholinergic activity. * Has undergone eye surgery involving the cornea or conjunctiva. * Aqueous deficient DED patients. * Is currently or has used any of the study drops in the last 3 months. * Has any known allergy or intolerance to any of the study drops. * Has any known active ocular disease such as allergies and/or infection or any ocular disease that in the opinion of the investigator may affect a study outcome variable * Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (e.g. uncontrolled autoimmune disease or uncontrolled immunodeficiency disease). * Has known sensitivity to sodium fluorescein. * Is pregnant, lactating or planning a pregnancy at the time of enrolment? * Unwilling to stop using their habitual artificial tears for the study. * Has been fitted with punctal plugs within 30 days before the study screening visit. * Contact lens users can still qualify for the study, however, participants should restrain their contact lens use to a very minimum during the study duration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescein Tear Break-Up Time (FTBUT) in seconds | Day 1 - 30 minutes post installation | The primary outcome of the study is FBUT at 30 minutes post-installation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fluorescein Tear Break-Up Time (FTBUT) in seconds | Day 7 - day 28 | One of the secondary endpoints is FTBUT at day 7 and day 28 |
| Tear Meniscus Height (TMH) in milimiters | Day 1 - Day 7 - day 28 | One of the secondary endpoints is TMH at day 1 (30 minutes post-installation), 7 and day 28 |
| Osmolarity in mOsm/L | Day 1 - Day 7 - day 28 | One of the secondary endpoints is osmolarity at day 1 (30 minutes post-installation), 7 and day 28 |
| Number of Corneal and Conjunctival spots | Day 7 - day 28 | One of the secondary endpoints is Corneal and conjunctival spots at day 7 and day 28 |
| Ocular Surface and Disease Index (OSDI) score | Day 7 - day 28 | One of the secondary endpoints is OSDI score at day 7 and day 28 |
Contacts
Primary ContactKarim Fahmy, Ph.D.
Outcome results
None listed