Clinical trial NCT02102464: Treatment of Meibomian Gland Dysfunction and Dry Eye in Contact Lens Wearers
Official title: Pilot Study for Treatment of Meibomian Gland Dysfunction and Evaporative Dry Eye in Contact Lens Wearers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Meibomian Gland Dysfunction
Dry Eye
Lead sponsor: TearScience, Inc.
Sponsor class: INDUSTRY
First posted: 2014-04-03
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: Mean Change in Meibomian Gland Score From Baseline at 3 Months
timeFrame: 3 Months
Secondary outcomes:
measure: Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months
timeFrame: 3 Months
Other outcomes:
measure: Mean Change in Comfortable Contact Lens Wear Time From Baseline at 3 Months
timeFrame: 3 Months
measure: Mean Change in Meibomian Gland Score From Baseline at 1 Month
timeFrame: 1 Month
measure: Mean Change in Dry Eye Questionnaire From Baseline at 1 Month
timeFrame: 1 Month
measure: Mean Change in Comfortable Contact Lens Wear Time From Baseline at 1 Month
timeFrame: 1 Month
Locations:
city: Birmingham
country: United States
facility: School of Optometry, The University of Alabama at Birmingham
state: Alabama
city: Morrow
country: United States
facility: Clayton Eye Center
state: Georgia
city: Charlotte
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates, P.A.
state: North Carolina
city: Hanover
country: United States
facility: May Eye Care Center & Associates
state: Pennsylvania
city: Kirkland
country: United States
facility: Specialty Eyecare Group
state: Washington
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research
state: Ontario
Study officials:
affiliation: TearScience, Inc.
name: Christy Coleman, OD, MPH
role: STUDY_DIRECTOR
References: