An interventional study of LacriFill Canalicular Filler in Dry Eye Syndrome, sponsored by Mann Eye Institute. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 39 Years. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Mann Eye Institute · Not applicable, Interventional, and Basic science
This study is a single-site, prospective, randomized (2:1) controlled study of subjects aged 18-39 who are candidates for bilateral LASIK and have dry eye symptoms (OSDI ≥13). The LacriFill group (n=50) receives bilateral lower canalicular LacriFill placement within 7 days prior to surgery plus standard postoperative care; the control group (n=25) receives standard postoperative care only. The primary outcome is the change in Ocular Surface Disease Index (OSDI) score from baseline to 3 months after bilateral LASIK.
1,366 studies on the registry are indexed under Dry Eye Syndromes; 207 are open to participants now.
This study's planned enrollment of 75 is above the median of 60 across 1,129 interventional studies indexed under Dry Eye Syndromes.
Browse Dry Eye Syndromes studies →Mann Eye Institute is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Age 18-39 years. Bilateral LASIK candidate. OSDI ≥13. BCDVA 20/20 or better. Discontinue soft contact lenses within 5 days of surgery and RGP lenses 4 weeks prior.
Able to complete study visits.
Exclusion Criteria:
Previous ocular surgery. Keratoconus or ectasia. disease. Pregnancy. Uncontrolled diabetes. Significant ocular surface disease unrelated to LASIK. Active ocular infection or inflammation.
The principal investigator reserves the right to declare a patient ineligible or non-evaluable based on medical evidence that indicates they are unsuitable for the trial.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Standard postoperative LASIK care plus bilateral lower canalicular LacriFill placement within 7 days prior to surgery (n=50).
Device: LacriFill Canalicular Filler
Standard postoperative LASIK care only; no punctal plugs, LacriFill, or other canalicular occlusion before completion of the primary 3-month endpoint unless medically necessary as rescue therapy (n=25).
LacriFill, a crosslinked hyaluronic acid-based bioresorbable gel, instilled for bilateral lower canalicular occlusion within 7 days prior to LASIK surgery.
Change from baseline in Ocular Surface Disease Index (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. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Time frame: 12 weeks
Change from baseline in Ocular Surface Disease Index (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. The OSDI© is a valid and reliable instrument for measuring dry eye disease (normal, mild to moderate, and severe) and effect on vision-related function.
Time frame: 12 weeks
Proportion of subjects achieving ≥10-point improvement in OSDI score
Proportion of subjects achieving an improvement of 10 points or more in OSDI score from baseline following bilateral LASIK.
Time frame: 12 weeks
Proportion of subjects achieving OSDI score <13
Proportion of subjects with an OSDI score below 13 (normal range) at the 12-week postoperative visit.
Time frame: 12 weeks
Change from baseline in tear break-up time (TBUT)
Time frame: 12 weeks
Change from baseline in corneal fluorescein staining (National Eye Institute Corneal Staining Scale)
Time frame: 12 weeks
Uncorrected distance visual acuity (UDVA)
Time frame: 12 weeks
Corrected distance visual acuity (CDVA)
Time frame: 12 weeks
Manifest refraction
Time frame: 12 weeks
Artificial tear usage and time to discontinuation of routine artificial tears
Artificial tear usage, time to discontinuation of routine artificial tears, and requirement for rescue dry eye therapy through the 12-week postoperative visit.
Time frame: 12 weeks
Requirement for rescue dry eye therapy
Incidence and documentation (indication, timing, treatment administered) of rescue dry eye therapy through the 12-week postoperative visit.
Time frame: 12 weeks
PROWL-SS Questionnaire
PROWL-SS can be used to assess satisfaction with vision and the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items). Subjects select one of 6 responses for each question. Responses are scaled from 0 to 100, with 0 being a worse overall outcome and 100 being a better overall outcome for the existence, bothersomeness and impact on usual activities in the last 7 days of four visual symptoms - double images (8 items), glare (8 items), halos (8 items) and starbursts (8 items).
Time frame: 12 weeks
Change from baseline in iTrace Corneal Performance Index (CPI)
Objective optical quality measure assessed at baseline and12-week postoperative visit.
Time frame: 12 weeks
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Dec 2026; primary completion for Dec 2027, 12 months later.
Of 199 non-industry interventional studies with no phase under Dry Eye Syndromes, half reached primary completion within 12 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 12 months is close to that.
Counting every sponsor, half of 312 studies reached it within 10 months; a quarter within 4 and three quarters within 18.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Mann Eye Institute