Dry EyePhase 4NCT07510620
Single-Arm Study of a Treatment for Dry Eye in People Who Struggle to Wear Contact Lenses
A Phase 4 study testing Lacrifill in people with Dry Eye, run by Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists at 1 site in United States.
Trial summary
This research study is to see if using Lacrifill is safe, easy to use, and helpful for people who wear contact lenses but can't wear them comfortably for long. Specifically, the study aims to determine whether regular use of Lacrifill over a 2-3 month period can help people wear their contacts longer without… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Dry Eye
- What is being tested?
- Lacrifill
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Dec 2025to Aug 2026
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >21 years of age
- Contact lens wearer
- Previous Dry Eye Treatment
- Be on a stable dose of antihistamines/Birth Control Medication and Lifitegrast and cyclosporine.
- Schrimers Anesthetized less than or equal to 10
- CLDEQ-8 greater than or equal to 12
- Corneal Staining NEI grading scale greater than or equal to 1
Who cannot join
- Known allergy to Hyaluronic Acid
- Current topical ophthalmic drops other than dry eye treatment
- Uncontrolled Diabetes
- Diabetic Retinopathy
- Pregnancy or Lactating
- Corneal Surgery (except Refractive)
Show all 9Show fewer
- Corneal Scars
- Keratoconus
- Ocular Herpetic Keratitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Cheryl Bayley contact
United States1 site, 1 recruiting
- Recruiting
Eye Care Specialists
Kingston, Pennsylvania, 18704
Patti Myers, 877-489-7405, patti.myers@vipeyes.com
About this study
Official title: Prospective, Single Arm Clinical Trial for the Treatment of Dry Eyes Signs and Symptoms in Patients With Limited Tolerability of Contact Lens Wear
This research study is to see if using Lacrifill is safe, easy to use, and helpful for people who wear contact lenses but can't wear them comfortably for long. Specifically, the study aims to determine whether regular use of Lacrifill over a 2-3 month period can help people wear their contacts longer without discomfort and reduce signs and symptoms of dry eye.
- Conditions
- Dry Eye
- Being tested
- Lacrifill
- Keywords
- Dry Eye, Lacrifill, contact lenses
- 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
Lacrifill is a cross-linked hyaluronic acid derivative that temporarily blocks tear drainage, allowing patients eyed to be bathed in their own natural tears.
| Study group | Role | What they receive |
|---|---|---|
| Lacrifill | Experimental | Not described Receives: Drug: Lacrifill |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dry eye signs
To asses the effect of Lacrifill.
Measured: 2-3 months
Dry Eye Symptoms
To asses the effect of Lacrifill.
Measured: 2-3 Months
Contact Lens Tolerability
To asses the effect of Lacrifill.
Measured: 2-3 Months
Secondary outcomes (6)
Evaluate Changes in CLDEQ-8 Questionnaire
To assess the effect of Lacrifill
Measured: 2-3 Months
Evaluate the Changes in the OSDI Questionnaire
To assess the effect of Lacrifill
Measured: 2-3 Months
Evaluate changes in Contact Lens Wear Time
To assess the effect of Lacrifill
Measured: 2-3 Months
Evaluate Clinical Signs of Tear Break Up Time
To assess the effect of Lacrifill
Measured: 2-3 Months
Evaluate Clinical Signs of Corneal Staining
To assess the effect of Lacrifill
Measured: 2-3 Months
Evaluate clinical Signs of Schirmer's Tear Test
To assess the effect of Lacrifill
Measured: 2-3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2026
- Study start12 Dec 2025
- Primary completionJul 2026 (estimated)
- Study completionAug 2026 (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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists
- Sponsor type
- University, hospital or other
- Collaborators
- Nordic Pharma, USA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07510620
- Sponsor's protocol ID
- LAC-IST-001
- Status last verified
- Apr 2026
- First submitted
- 10 Dec 2025
- Last updated
- 3 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Unique study ID (no direct identifiers) Demographic characteristics (e.g., age, sex, race/ethnicity) Baseline clinical characteristics relevant to the study Outcome data (primary and secondary endpoints) Adverse events and serious adverse events Concomitant medications Intervention/exposure data Follow-up assessments and visit dates
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm Clinical Trial for the Treatment of Dry Eyes Signs and Symptoms in Patients With Limited Tolerability of Contact Lens Wear
- ClinicalTrials.gov ID
- NCT07510620
- Acronym / sponsor ID
- LAC-IST-001
- Conditions
- Dry Eye
- Keywords
- Dry Eye, Lacrifill, contact lenses
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care SpecialistsUniversity, hospital or other
- Collaborators
- Nordic Pharma, USA
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Aug 2026 (estimated)
- First posted
- 3 Apr 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 research study is to see if using Lacrifill is safe, easy to use, and helpful for people who wear contact lenses but can't wear them comfortably for long. Specifically, the study aims to determine whether regular use of Lacrifill over a 2-3 month period can help people wear their contacts longer without discomfort and reduce signs and symptoms of dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacrifill | Experimental | Drug: Lacrifill |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- >21 years of age
- Contact lens wearer
- Previous Dry Eye Treatment
- Be on a stable dose of antihistamines/Birth Control Medication and Lifitegrast and cyclosporine.
- Schrimers Anesthetized less than or equal to 10
Key exclusion criteria (9 listed)
- Known allergy to Hyaluronic Acid
- Current topical ophthalmic drops other than dry eye treatment
- Uncontrolled Diabetes
- Diabetic Retinopathy
- Pregnancy or Lactating
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 |
|---|---|---|
| LacrifillLacrifill is a cross-linked hyaluronic acid derivative that temporarily blocks tear drainage, allowing patients eyed to be bathed in their own natural tears. | Drug | Lacrifill |
Primary outcome
Dry eye signs
Time frame: 2-3 months
To asses the effect of Lacrifill.
Dry Eye Symptoms
Time frame: 2-3 Months
To asses the effect of Lacrifill.
Contact Lens Tolerability
Time frame: 2-3 Months
To asses the effect of Lacrifill.
6 secondary outcomes
Evaluate Changes in CLDEQ-8 Questionnaire
Time frame: 2-3 Months
Evaluate the Changes in the OSDI Questionnaire
Time frame: 2-3 Months
Evaluate changes in Contact Lens Wear Time
Time frame: 2-3 Months
Evaluate Clinical Signs of Tear Break Up Time
Time frame: 2-3 Months
Evaluate Clinical Signs of Corneal Staining
Time frame: 2-3 Months
Evaluate clinical Signs of Schirmer's Tear Test
Time frame: 2-3 Months
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 Apr 2026.
- Individual participant dataSharing planned: Yes. Unique study ID (no direct identifiers) Demographic characteristics (e.g., age, sex, race/ethnicity) Baseline clinical characteristics relevant to the study Outcome data (primary and secondary endpoints) Adverse events and serious adverse events Concomitant medications Intervention/exposure data Follow-up assessments and visit dates
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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.
Cheryl Bayley contact
1 site 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 in people with Dry Eye, run by Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists 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 7 inclusion and 9 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 3 Apr 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.
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?
Contact Patti Myers, COT (5707145910, patti.myers@vipeyes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dry eye signs (time frame: 2-3 months). The study lists 3 primary outcomes in all. 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 Apr 2026.