NCT01808560

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2013

Typical duration for not_applicable

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2013

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 11, 2013

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

May 14, 2018

Completed
Last Updated

September 4, 2018

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

March 7, 2013

Results QC Date

March 9, 2018

Last Update Submit

August 30, 2018

Conditions

BlepharitisDry Eye Syndrome

Outcome Measures

Primary Outcomes (1)

  • Mean Change in Total Meibomian Gland Score

    The primary endpoint is the mean change in total meibomian gland score in the Pre-treatment group compared to the Untreated group from Baseline after cataract surgery. Meibomian gland assessment was performed to evaluate the function of the meibomian glands based on the secretion characteristics from the gland orifices along the lower eyelid. Under a slit-lamp biomicrosope, the gland orifices were evaluated using a handheld instrument, Meibomian Gland Evaluator. This instrument provided a standardized method of applying the same amount of pressure and for each eye to ensure measurement consistency. A total of 15 glands were evaluated including five glands each in the temporal, central and nasal regions of the lower eyelid. For each gland, secretion characteristics were graded as 3 (clear liquid), 2 (cloudy liquid), 1 (inspissated/toothpaste consistency) and 0 (no secretion). The total meibomian gland score is the sum of the grades for all 15 glands with a range of 0 to 45.

    Baseline and 3 Months post-surgery

Secondary Outcomes (1)

  • Mean Change in Dry Eye Questionnaire Score From Baseline at 3 Months

    Baseline and 3 Months post-surgery

Other Outcomes (4)

  • Mean Change in Ocular Surface Disease Index (OSDI) Questionnaire Score From Baseline at 3 Months

    Baseline and 3 Months post-surgery

  • Mean Change in NEI-VFQ Questionnaire Score From Baseline at 3 Months

    Baseline and 3 Months post-surgery

  • Mean Change in Number of MGYLS (Meibomian Glands Yielding Liquid Secretion)

    Baseline and 3 Months post-surgery

  • +1 more other outcomes

Study Arms (3)

LipiFlow Pre-treatment

EXPERIMENTAL

Subjects randomized to the LipiFlow Pre-Treatment group receive a 12-minute LipiFlow System treatment for MGD in both eyes one month prior to cataract surgery.

Device: LipiFlow Pre-Treatment

Untreated Control

NO INTERVENTION

Subjects randomized to the untreated control group receive no MGD treatment prior to cataract surgery.

LipiFlow Post-treatment

EXPERIMENTAL

Subjects in the untreated control group receive a 12-minute crossover treatment with the LipiFlow System in both eyes three months after cataract surgery.

Device: LipiFlow Post-treatment

Interventions

LipiFlow Pre-TreatmentDEVICE

The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.

Also known as: LipiFlow Thermal Pulsation System
LipiFlow Pre-treatment
LipiFlow Post-treatmentDEVICE

The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction, also known as evaporative dry eye or lipid deficiency dry eye.

Also known as: LipiFlow Thermal Pulsation System
LipiFlow Post-treatment

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Chicago Cornea Consultants, Ltd.

Hoffman Estates, Illinois, 60169, United States

Location

Jackson Eye

Lake Villa, Illinois, 60046, United States

Location

Charles River Eye Associates

Winchester, Massachusetts, 01890, United States

Location

Associated Eye Care

Stillwater, Minnesota, 55082, United States

Location

Ophthalmology Consultants, Ltd.

St Louis, Missouri, 63131, United States

Location

The May Eye Care Center

Hanover, Pennsylvania, 17833, United States

Location

Carolina EyeCare Physicians, LLC

Mt. Pleasant, South Carolina, 29464, United States

Location

MeSH Terms

Conditions

BlepharitisDry Eye Syndromes

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye DiseasesLacrimal Apparatus Diseases

Results Point of Contact

Title
Manager of Clinical and Medical Affairs
Organization
TearScience, Inc.
LJi4@its.jnj.com
919-459-4842

Study Officials

  • Christy Stevens, OD, MPH

    TearScience

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 11, 2013

Study Start

March 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

September 4, 2018

Results First Posted

May 14, 2018

Record last verified: 2018-08

Locations

US(7)