A Pilot Comparative study between I-DROP MGD vs two commercially available lubricant eye drops for the management of evaporative dry eye
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
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
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
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
Fluorescein Tear Break-Up Time (FTBUT) in seconds
The primary outcome of the study is FBUT at 30 minutes post-installation
Time frame: Day 1 - 30 minutes post installation
Fluorescein Tear Break-Up Time (FTBUT) in seconds
One of the secondary endpoints is FTBUT at day 7 and day 28
Time frame: Day 7 - day 28
Tear Meniscus Height (TMH) in milimiters
One of the secondary endpoints is TMH at day 1 (30 minutes post-installation), 7 and day 28
Time frame: Day 1 - Day 7 - day 28
Osmolarity in mOsm/L
One of the secondary endpoints is osmolarity at day 1 (30 minutes post-installation), 7 and day 28
Time frame: Day 1 - Day 7 - day 28
Number of Corneal and Conjunctival spots
One of the secondary endpoints is Corneal and conjunctival spots at day 7 and day 28
Time frame: Day 7 - day 28
Ocular Surface and Disease Index (OSDI) score
One of the secondary endpoints is OSDI score at day 7 and day 28
Time frame: Day 7 - day 28
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