This study is designed to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug.
The objective of this study is to evaluate the clinical utility and safety of the Visant Medical Canalicular Plug compared to a commercially available canalicular plug over 6 months of subject follow-up. Study subjects who are eligible for enrollment and have provided written informed consent will be randomized in a 2:1 ratio (i.e., 2 subjects randomized to the Visant Medical Canalicular Plug for every 1 subject randomized to a commercially available canalicular plug). All study subjects will be treated bilaterally with plugs placed in the inferior canaliculi.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
156
Plug is inserted into the inferior canaliculi and assessed for 6 months
Plug is inserted into the inferior canaliculi and assessed for 6 months
Schwartz Laser Eye Center
Scottsdale, Arizona, United States
Eye Research Foundation, Inc.
Newport Beach, California, United States
Andover Eye Associates
Andover, Massachusetts, United States
Piedmont Eye, Inc.
Lynchburg, Virginia, United States
Mean change in Schirmer's score from baseline to Month 3 compared to commercially available plug
Non-inferiority hypothesis. Higher Score using this continuous variable equates to larger tear film
Time frame: 3 months
Proportion of responders achieving improvement from Baseline in Ocular Surface Disease Index (OSDI) score by a Minimal Clinically Important Difference (MCID).
Non-inferiority hypothesis. Scale of 0-100. Lower OSDI score means fewer symptoms.
Time frame: 3 months
Mean change in tear meniscus height from baseline
Null hypothesis of no improvement from baseline. Larger measurement equates to larger tear film.
Time frame: Month 3
Mean change in OSDI score from baseline
Null hypothesis of no improvement from baseline. Non-inferiority hypothesis. Scale of 0-100. Lower OSDI score means fewer symptoms.
Time frame: Month 3
Mean change in corneal staining score from baseline (NEI workshop scale)
Null hypothesis of no improvement from baseline. Scale is 0-15. More staining is associated with more severe dry eye.
Time frame: Month 3
Mean change in tear meniscus height from baseline
Null hypothesis of no improvement from baseline. Larger measurement equates to larger tear film.
Time frame: Month 6
Mean change in OSDI score from baseline
Null hypothesis of no improvement from baseline. Non-inferiority hypothesis. Scale of 0-100. Lower OSDI score means fewer symptoms.
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See Clearly Vision
McLean, Virginia, United States
Time frame: Month 6
Mean change in corneal staining score from baseline (NEI workshop scale)
Null hypothesis of no improvement from baseline. Scale is 0-15. More staining is associated with more severe dry eye.
Time frame: Month 6
Mean change in tear break up time from baseline
Null hypothesis of no improvement from baseline. Increased time equates to more stable tear film
Time frame: Month 3
Mean change in Schirmer score from baseline
Null hypothesis of no improvement from baseline. Higher Score using this continuous variable equates to larger tear film
Time frame: Month 6
Mean change in tear break up time from baseline
Null hypothesis of no improvement from baseline. Increased time equates to more stable tear film
Time frame: Month 6