Lacrifill for contact lens wearers with dry eye who can't wear lenses comfortably
Prospective, Single Arm Clinical Trial for the Treatment of Dry Eyes Signs and Symptoms in Patients With Limited Tolerability of Contact Lens Wear
This trial will try Lacrifill eye drops in adults with dry eye who have trouble wearing contact lenses to see if regular use helps them wear lenses longer with less discomfort.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 22 Years and up |
| Sex | All |
| Sponsor | Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists Academic / other |
| Locations | 1 site (Kingston, Pennsylvania) |
| Trial ID | NCT07510620 on ClinicalTrials.gov |
What this trial studies
This is a Phase 4, single-arm interventional study giving Lacrifill eye drops to adult contact lens wearers with dry eye over a two- to three-month period to measure comfort and ocular surface signs. Eligible participants are over 21, currently wear contact lenses, have prior dry eye treatment, CLDEQ-8 ≥12, Schirmer anesthetized ≤10, and corneal staining NEI ≥1, and may remain on stable permitted medications. The protocol tracks contact lens wearing time, symptom scores, Schirmer testing, and corneal staining without a randomized control group. The trial is sponsored by Vision Innovation Centers of Pennsylvania in collaboration with Nordic Pharma and is conducted at Eye Care Specialists in Kingston, PA.
Who should consider this trial
Good fit: Adults over 21 who currently wear contact lenses, have moderate-to-severe dry eye symptoms (CLDEQ-8 ≥12), Schirmer ≤10, and corneal staining ≥1, and who are stable on permitted medications are ideal candidates.
Not a fit: People with a known hyaluronic acid allergy, active corneal disease (e.g., herpetic keratitis, keratoconus, corneal scars), uncontrolled diabetes, or those who are pregnant or breastfeeding are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, regular Lacrifill use could let people with dry eye wear contact lenses longer and feel less discomfort while improving ocular surface test results.
How similar studies have performed: Hyaluronic acid–based lubricants have previously shown benefit for dry eye and contact lens comfort, but this specific Lacrifill formulation has limited published data in this exact population.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria * \>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 Exclusion Criteria: * 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) * Corneal Scars * Keratoconus * Ocular Herpetic Keratitis
Where this trial is running
Kingston, Pennsylvania
- Eye Care Specialists — Kingston, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Patti Myers, COT
- Email: patti.myers@vipeyes.com
- Phone: 5707145910
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.