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

ConditionDry Eye
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age22+
SponsorVision Innovation Centers of Pennsylvania, LLC d/b/a Eye Care Specialists

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

>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.

Disqualifiers

Known allergy to Hyaluronic Acid

Current topical ophthalmic drops other than dry eye treatment

Uncontrolled Diabetes

Diabetic Retinopathy

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: LacrifillExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dry eye signs

To asses the effect of Lacrifill.

Time frame
2-3 months
2

Dry Eye Symptoms

To asses the effect of Lacrifill.

Time frame
2-3 Months
3

Contact Lens Tolerability

To asses the effect of Lacrifill.

Time frame
2-3 Months

Secondary outcomes

1

Evaluate Changes in CLDEQ-8 Questionnaire

To assess the effect of Lacrifill

Time frame
2-3 Months
2

Evaluate the Changes in the OSDI Questionnaire

To assess the effect of Lacrifill

Time frame
2-3 Months
3

Evaluate changes in Contact Lens Wear Time

To assess the effect of Lacrifill

Time frame
2-3 Months
4

Evaluate Clinical Signs of Tear Break Up Time

To assess the effect of Lacrifill

Time frame
2-3 Months

Other outcomes

Sponsors and contacts

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