Clinical trial NCT01808560: Treatment of Meibomian Gland Dysfunction Prior to Cataract Surgery
Official title: Pilot Study for Treatment of Meibomian Gland Dysfunction (MGD) Prior to Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blepharitis
Dry Eye Syndrome
Lead sponsor: TearScience, Inc.
Sponsor class: INDUSTRY
First posted: 2013-03-11
Enrollment: 34
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot feasibility study is to assess whether treating meibomian gland dysfunction (MGD) prior to cataract surgery helps promote meibomian gland function, visual quality and ocular comfort after cataract surgery.

Detailed description: This is a post-market, prospective, non-significant risk, open-label, randomized multi-center clinical trial evaluating treatment with the LipiFlow System in patients with meibomian gland dysfunction prior to planned bilateral cataract surgery. All subjects undergo examination to determine study eligibility and to capture the Baseline status prior to surgery. Subjects are randomized to receive LipiFlow treatment (Pre-treatment group) one month before cataract surgery or no LipiFlow treatment (Untreated Control group). Cataract surgery is performed on both eyes of each subject with the second eye surgery completed within two months of the first eye. All subjects are evaluated at one month and three months after cataract surgery on the second eye with comparison of the study endpoints between the Pre-treatment and Untreated groups. To facilitate subject recruitment, the Untreated Control group receives crossover LipiFlow treatment for MGD (Post-treatment group) three months after cataract surgery on the second eye.

Eligibility criteria: Inclusion Criteria:

* 55 to 85 years of age
* Must be able to comply with protocol including study randomization; completion of planned bilateral cataract surgery; no use of other MGD or dry eye treatments during the study; and attendance at all study visits
* Meibomian gland dysfunction in both eyes based on total meibomian gland score
* None to mild dry eye symptoms based on Ocular Surface Disease Index score
* Tear film interferometry assessment of 100 units or less

Exclusion Criteria:

* Systemic disease conditions that causes dry eye
* Use of systemic medications known to cause dry eye
* Use of other MGD or dry eye treatments except for over the counter lubricants or dietary supplements
* 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
* Participation in another ophthalmic drug or device trial in the past month

Primary outcomes:
measure: Mean Change in Total Meibomian Gland Score
timeFrame: Baseline and 3 Months post-surgery
Secondary outcomes:
measure: Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months
timeFrame: Baseline and 3 Months post-surgery
Other outcomes:
measure: Mean Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From Baseline at 3 Months
timeFrame: Baseline and 3 Months post-surgery
measure: Mean Change in NEI-VFQ Questionnaire Score From Baseline at 3 Months
timeFrame: Baseline and 3 Months post-surgery
measure: Mean Change in Number of MGYLS (Meibomian Glands Yielding Liquid Secretion)
timeFrame: Baseline and 3 Months post-surgery
measure: Mean Change in Tear Break-up Time (TBUT)
timeFrame: Baseline and 3 Months post-surgery
Locations:
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, Ltd.
state: Illinois
city: Lake Villa
country: United States
facility: Jackson Eye
state: Illinois
city: Winchester
country: United States
facility: Charles River Eye Associates
state: Massachusetts
city: Stillwater
country: United States
facility: Associated Eye Care
state: Minnesota
city: Saint Louis
country: United States
facility: Ophthalmology Consultants, Ltd.
state: Missouri
city: Hanover
country: United States
facility: The May Eye Care Center
state: Pennsylvania
city: Mount Pleasant
country: United States
facility: Carolina EyeCare Physicians, LLC
state: South Carolina
Study officials:
affiliation: TearScience
name: Christy Stevens, OD, MPH
role: STUDY_DIRECTOR
References: