Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers

TearScience

Status: Completed

Conditions: Dry Eye; Meibomian Gland Dysfunction

Treatments: Device: LipiFlow treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT02102464

LF006

Details and patient eligibility

About

The pilot study objective is to evaluate the potential benefits of LipiFlow® System treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye by assessing for improvement in meibomian gland function and reduction of dry eye symptoms in comparison to an untreated control.

Full description

This is a prospective, non-significant risk, open-label, randomized clinical trial of LipiFlow® treatment of contact lens wearers with meibomian gland dysfunction and evaporative dry eye. All subjects undergo examination to determine study eligibility and to capture the Baseline status. Subjects are randomized to receive LipiFlow® treatment (Treatment Group) or no LipiFlow® treatment (Untreated Control Group). The Treatment group is evaluated one month after receiving LipiFlow® treatment. Study endpoints are evaluated at 3 Months by comparing the Treatment Group to the Untreated Group. To facilitate subject recruitment, the Untreated Control group receives Crossover LipiFlow® treatment (Crossover Treatment Group) at 3 Months. The Crossover Treatment group is evaluated one month after receiving LipiFlow® treatment (4 Months visit).

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of meibomian gland dysfunction and dry eye
• At least 18 years of age
• Willing to comply with randomization, attend all study visits and follow patient instructions
• Habitual soft contact lens wearer 2 to 18 hours/day and 4 to 7 days/week
• No change in contact lens type or dimensions for the past 3 months
• Clinician assessment of acceptable contact lens fit and disinfecting solution
• Tear film interferometry of 100 units or less

Exclusion criteria

• Systemic disease conditions that cause dry eye
• Use of systemic medications known to cause dryness
• History of any of the following ocular conditions in the past 3 months: surgery, trauma, Herpes infection, recurrent inflammation, punctal plug insertion or punctal occlusion
• Presence of any of the following active conditions: ocular infection, ocular inflammation, moderate to severe allergic conjunctivitis, severe eyelid inflammation, eyelid abnormality that affects lid function, or ocular surface abnormality that compromises corneal integrity
• Use of other treatments for meibomian gland dysfunction or dry eye except over the counter lubricants or dietary supplements
• Participation in another ophthalmic drug or device trial in the past month
• Employee, relative of employee or associate of the clinical site

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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55 participants in 3 patient groups

LipiFlow

Experimental group

Description:

Single 12-minute LipiFlow treatment

Treatment:

Device: LipiFlow treatment

Untreated Control

No Intervention group

Description:

Untreated Control (No Intervention)

Crossover LipiFlow Treatment

Experimental group

Description:

Crossover LipiFlow treatment of the untreated control group after 3 months

Treatment:

Device: LipiFlow treatment