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Single-Arm Study of a Treatment for Dry Eye in People Who Struggle to Wear Contact Lenses

Prospective, Single Arm Clinical Trial for the Treatment of Dry Eyes Signs and Symptoms in Patients With Limited Tolerability of Contact Lens Wear

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07510620
Enrollment
30
Registered
2026-04-03
Start date
2025-12-12
Completion date
2026-08-01
Last updated
2026-04-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye

Keywords

Dry Eye, Lacrifill, contact lenses

Brief 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 discomfort and reduce signs and symptoms of dry eye.

Interventions

DRUGLacrifill

Lacrifill is a cross-linked hyaluronic acid derivative that temporarily blocks tear drainage, allowing patients eyed to be bathed in their own natural tears.

Sponsors

Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists
Lead SponsorOTHER
Nordic Pharma, USA
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Dry eye signs2-3 monthsTo asses the effect of Lacrifill.
Dry Eye Symptoms2-3 MonthsTo asses the effect of Lacrifill.
Contact Lens Tolerability2-3 MonthsTo asses the effect of Lacrifill.

Secondary

MeasureTime frameDescription
Evaluate Changes in CLDEQ-8 Questionnaire2-3 MonthsTo assess the effect of Lacrifill
Evaluate the Changes in the OSDI Questionnaire2-3 MonthsTo assess the effect of Lacrifill
Evaluate changes in Contact Lens Wear Time2-3 MonthsTo assess the effect of Lacrifill
Evaluate Clinical Signs of Tear Break Up Time2-3 MonthsTo assess the effect of Lacrifill
Evaluate Clinical Signs of Corneal Staining2-3 MonthsTo assess the effect of Lacrifill
Evaluate clinical Signs of Schirmer's Tear Test2-3 MonthsTo assess the effect of Lacrifill

Countries

United States

Contacts

CONTACTPatti Myers, COT
patti.myers@vipeyes.com5707145910
CONTACTCheryl Bayley
5707145915

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 4, 2026