Dry Eye SyndromeNCT07911930
LacriFill Canalicular Occlusion for Dry Eye After LASIK
A study testing LacriFill Canalicular Filler in people with Dry Eye Syndrome, run by Mann Eye Institute at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 39 years
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- LacriFill Canalicular Filler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Previous ocular surgery. Keratoconus or ectasia. Autoimmune 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mann Eye Institute
Houston, Texas, 77004
Melissa Hamann Wright, 713-580-2500 ext. 2389, Melissa.Wright@manneye.com
Phillip Brunson, OD
About this study
Official title: Impact of LacriFill Lacrimal Occlusion on Post-LASIK Dry Eye Symptoms, Ocular Surface Recovery, and Patient-Reported Visual Quality
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.
- Conditions
- Dry Eye Syndrome
- Being tested
- LacriFill Canalicular Filler
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LacriFill Canalicular FillerDevice
LacriFill, a crosslinked hyaluronic acid-based bioresorbable gel, instilled for bilateral lower canalicular occlusion within 7 days prior to LASIK surgery.
| Study group | Role | What they receive |
|---|---|---|
| LacriFill Group | Experimental | Standard postoperative LASIK care plus bilateral lower canalicular LacriFill placement within 7 days prior to surgery (n=50). Receives: Device: LacriFill Canalicular Filler |
| Control Group | No intervention | 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Change from baseline in tear break-up time (TBUT)
Measured: 12 weeks
Change from baseline in corneal fluorescein staining (National Eye Institute Corneal Staining Scale)
Measured: 12 weeks
Uncorrected distance visual acuity (UDVA)
Measured: 12 weeks
Corrected distance visual acuity (CDVA)
Measured: 12 weeks
Manifest refraction
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study start9 Dec 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mann Eye Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Sengi
- Responsible party
- Sponsor
- Investigators
- Phillip Brunson, OD, Principal investigator, Mann Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07911930
- Sponsor's protocol ID
- PB-26-01
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of LacriFill Lacrimal Occlusion on Post-LASIK Dry Eye Symptoms, Ocular Surface Recovery, and Patient-Reported Visual Quality
- ClinicalTrials.gov ID
- NCT07911930
- Acronym / sponsor ID
- PB-26-01
- Conditions
- Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Mann Eye InstituteUniversity, hospital or other
- Collaborators
- Sengi
- Study start
- 9 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LacriFill Group | Experimental | Device: LacriFill Canalicular FillerStandard postoperative LASIK care plus bilateral lower canalicular LacriFill placement within 7 days prior to surgery (n=50). |
| Control Group | No intervention | –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). |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- Previous ocular surgery. Keratoconus or ectasia. Autoimmune 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LacriFill Canalicular FillerLacriFill, a crosslinked hyaluronic acid-based bioresorbable gel, instilled for bilateral lower canalicular occlusion within 7 days prior to LASIK surgery. | Device | LacriFill Group |
Primary outcome
Change from baseline in Ocular Surface Disease Index (OSDI) score
Time frame: 12 weeks
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.
10 secondary outcomes
Change from baseline in Ocular Surface Disease Index (OSDI) score
Time frame: 12 weeks
Proportion of subjects achieving ≥10-point improvement in OSDI score
Time frame: 12 weeks
Proportion of subjects achieving OSDI score <13
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
Time frame: 12 weeks
Requirement for rescue dry eye therapy
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2026.
- Individual participant dataSharing planned: No
Related trials for Dry Eye Syndrome
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland
Not yet recruitingPhase 2
Evaluation of Allogenic Mesenchymal Stem Cell (MSC) Injection Therapy for Refractory Graft-versus-Host Disease (GVHD) Unresponsive to Conventional Treatments
Dry Eye Disease (DED), Graft-Versus-Host Disease(GVHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Phillip Brunson, OD principal investigator
Mann Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LacriFill Canalicular Filler in people with Dry Eye Syndrome, run by Mann Eye Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Hamann Wright, Study Staff (713-580-2500 ext. 2389, Melissa.Wright@manneye.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Ocular Surface Disease Index (OSDI) score (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2026.