Dry EyePhase 4NCT07796178
Evaluation of Lacrifill
A Phase 4 study testing Lacrifill and Saline in people with Dry Eye and Ocular Surface Disease, run by Eye Research Associates, LLC at 2 sites in United States.
Trial summary
Dry Eye Disease is defined as "a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Dry Eye, Ocular Surface Disease, Cataract Surgery
- What is being tested?
- Lacrifill and Saline
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 2 Sep 2026to 15 Feb 2027
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults ≥18 years of age.
- Have the potential of 20/40 visual acuity or better post-cataract surgery.
- have cataract surgery scheduled for both eyes
- Corneal staining score of ≥3 on the original National Eye Institute (NEI; 0-15 total score) staining scale in the study eye.
- willing to discontinue contact lens throughout the study?
- pre-treatment OSDI scores of ≤12 (asymptomatic)?
Who cannot join
- Known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)?
- History of ocular surgery within the past 12 months (excluding cataract surgery)
- Anticipated complications from cataract surgery in either eye?
- History of severe ocular trauma, active ocular infection or inflammation that is not dry eye-related?
- Used Accutane or is currently using ocular medications/treatments outside of study treatments? Artificial tears will be allowed.
- Physical meibomian gland treatment withing 1 month of enrollment?
- Having any conditions or are in a situation, which in the investigator's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation in the study.
- Currently pregnant or breast feeding
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Insight Eyecare Specialties Inc
Kansas City, Missouri, 64111
Crystal Remington, OD, 816-531-9100, drremington@vseyecare.com
Crystal Remington, OD
- Recruiting
Kannarr Eye Care
Pittsburg, Kansas, 66762
Shane Kannarr, OD, 620-232-3277, skannarr@kannarreyecare.com
Shane Kannarr, OD
About this study
Official title: Evaluation of Lacrifill Treatment for Alleviating Dry Eye Symptoms in Post-Operative Cataract Surgery Subjects
Dry Eye Disease is defined as "a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.' 'By the The Tear Film and Ocular Surface Society. Despite there being a number of factors that impact DED however one factor that has been considered likely is that of a complication from ocular surgery itself. Which can cause both corneal nerve, and ocular surface damage. Therefore this study aims to determine how Lacrfill performs in preventing post-operative dry eye symptoms in those who have recently had unilateral cataract surgery.
- Conditions
- Dry Eye, Ocular Surface Disease, Cataract Surgery, Eyes Dry Feeling of
- Being tested
- Lacrifill, Saline
- 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.
LacrifillDrug
Participants will receive Lacrifill achemically crosslinked, particulate hyaluronic acid (HA) hydrogel intracanalicular occlusion device that is intended to occlude tear drainage
SalineDrug
Participants will be provided with a saline eye drop which is standard of care for those recovering from cataract surgery, and other complications that could cause symptoms related to Dry Eye Disease.
| Study group | Role | What they receive |
|---|---|---|
| Lacrifill | Experimental | Qualifying subjects will be treated with Lacrifill via the manufacturer's instructions Receives: Drug: Lacrifill |
| Saline/Standard of care | Active comparator | Qualifying subjects will be treated with saline via the manufacturer's instructions Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale)
Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort.
Measured: 1-month post operative compared to pre-treatment
Secondary outcomes (3)
• OSDI Scores at the 3-month post-operative visit compared to pre-treatment (0-100 scale).
Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort.
Measured: pre-treatment as compared to 3 months post operative.
Eye Dryness visual analog scale (VAS) Scores 1 month post operative
The Eye Dryness visual analog scale VAS will be conducted 1 month post operative with higher scores indicating more discomfort. Scale 0-100 with score 0 representing No Symptoms and Score 100 representing Severe Symptoms.
Measured: 1 month post operative as compared to pre-treatment.
Eye Dryness visual analog scale (VAS) Scores 3 month post operative
The Eye Dryness visual analog scale VAS will be conducted 3 month post operative with higher scores indicating more discomfort. Scale 0-100 with score 0 representing No Symptoms and Score 100 representing Severe Symptoms.
Measured: 3 month post operative as compared to pre-treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start2 Sep 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion15 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Subjects will be randomized to either the Lacrifill group or the saline/standard of care. After eligibility requirements are meant.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eye Research Associates, LLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07796178
- Sponsor's protocol ID
- Lacrifill 101 IRB ID: 17131
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Lacrifill Treatment for Alleviating Dry Eye Symptoms in Post-Operative Cataract Surgery Subjects
- ClinicalTrials.gov ID
- NCT07796178
- Acronym / sponsor ID
- Lacrifill 101 IRB ID: 17131
- Conditions
- Dry Eye, Ocular Surface Disease, Cataract Surgery, Eyes Dry Feeling of
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eye Research Associates, LLCUniversity, hospital or other
- Study start
- 2 Sep 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 15 Feb 2027 (estimated)
- First posted
- 1 Sep 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.
Dry Eye Disease is defined as "a multifactorial disease of the tears and ocular surface that results in symptoms of discomfort, visual disturbance, and tear film instability with potential damage to the ocular surface. It is accompanied by increased osmolarity of the tear film and inflammation of the ocular surface.' 'By the The Tear Film and Ocular Surface Society. Despite there being a number of factors that impact DED however one factor that has been considered likely is that of a complication from ocular surgery itself. Which can cause both corneal nerve, and ocular surface damage. Therefore this study aims to determine how Lacrfill performs in preventing post-operative dry eye symptoms in those who have recently had unilateral cataract surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Subjects will be randomized to either the Lacrifill group or the saline/standard of care. After eligibility requirements are meant.
| Arm | Type | Receives |
|---|---|---|
| Lacrifill | Experimental | Drug: LacrifillQualifying subjects will be treated with Lacrifill via the manufacturer's instructions |
| Saline/Standard of care | Active comparator | Drug: SalineQualifying subjects will be treated with saline via the manufacturer's instructions |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults ≥18 years of age.
- Have the potential of 20/40 visual acuity or better post-cataract surgery.
- have cataract surgery scheduled for both eyes
- Corneal staining score of ≥3 on the original National Eye Institute (NEI; 0-15 total score) staining scale in the study eye.
- willing to discontinue contact lens throughout the study?
Key exclusion criteria (8 listed)
- Known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome)?
- History of ocular surgery within the past 12 months (excluding cataract surgery)
- Anticipated complications from cataract surgery in either eye?
- History of severe ocular trauma, active ocular infection or inflammation that is not dry eye-related?
- Used Accutane or is currently using ocular medications/treatments outside of study treatments? Artificial tears will be allowed.
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 |
|---|---|---|
| LacrifillParticipants will receive Lacrifill achemically crosslinked, particulate hyaluronic acid (HA) hydrogel intracanalicular occlusion device that is intended to occlude tear drainage | Drug | Lacrifill |
| SalineParticipants will be provided with a saline eye drop which is standard of care for those recovering from cataract surgery, and other complications that could cause symptoms related to Dry Eye Disease. | Drug | Saline/Standard of care |
Primary outcome
OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale)
Time frame: 1-month post operative compared to pre-treatment
Ocular Surface Disease Index scores will be determined on a scale with higher scores meaning more discomfort.
3 secondary outcomes
• OSDI Scores at the 3-month post-operative visit compared to pre-treatment (0-100 scale).
Time frame: pre-treatment as compared to 3 months post operative.
Eye Dryness visual analog scale (VAS) Scores 1 month post operative
Time frame: 1 month post operative as compared to pre-treatment.
Eye Dryness visual analog scale (VAS) Scores 3 month post operative
Time frame: 3 month post operative as compared to pre-treatment.
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 25 Sep 2026.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lacrifill and Saline in people with Dry Eye and Ocular Surface Disease, run by Eye Research Associates, LLC at 2 sites 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 6 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
OSDI Scores at the 1-month post-operative visit compared to pre-treatment (0-100 scale) (time frame: 1-month post operative compared to pre-treatment). 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 25 Sep 2026.