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NCT Number: NCT07510620

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

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.

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Key information

Conditions

Dry Eye Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Eye Care Specialists

Kingston, Pennsylvania, 18704, United States

Location status: Recruiting

Location contact

Patti Myers

CONTACT

[email protected]

877-489-7405

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lacrifill

Drug

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

Primary outcomes

  1. Dry eye signs

    Time frame: 2-3 months

    To asses the effect of Lacrifill.

  2. Dry Eye Symptoms

    Time frame: 2-3 Months

    To asses the effect of Lacrifill.

  3. Contact Lens Tolerability

    Time frame: 2-3 Months

    To asses the effect of Lacrifill.

Secondary outcomes

  1. Evaluate Changes in CLDEQ-8 Questionnaire

    Time frame: 2-3 Months

    To assess the effect of Lacrifill

  2. Evaluate the Changes in the OSDI Questionnaire

    Time frame: 2-3 Months

    To assess the effect of Lacrifill

  3. Evaluate changes in Contact Lens Wear Time

    Time frame: 2-3 Months

    To assess the effect of Lacrifill

  4. Evaluate Clinical Signs of Tear Break Up Time

    Time frame: 2-3 Months

    To assess the effect of Lacrifill

  5. Evaluate Clinical Signs of Corneal Staining

    Time frame: 2-3 Months

    To assess the effect of Lacrifill

  6. Evaluate clinical Signs of Schirmer's Tear Test

    Time frame: 2-3 Months

    To assess the effect of Lacrifill

Study contacts

Contact information is provided by the study sponsor or research team.

Cheryl Bayley

CONTACT

5707145915

Patti Myers, COT

CONTACT

[email protected]

5707145910

Sponsors and collaborators

Lead sponsor

Vision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists

Other

Collaborators

  • Nordic Pharma, USA

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2026
Registry last updated
Apr 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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