Trial Outcomes & Findings for Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction (NCT NCT01202747)

Results Overview

Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p\<0.05) association between the screening method and outcome. Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

50 participants

Primary outcome timeframe

Baseline and 4 Weeks

Results posted on

2011-12-06

Participant Flow

A total of 50 subjects (100 eyes) were enrolled at 3 investigational sites between 10/03/2010 and 11/15/2010.

Participant milestones

Participant milestones
Measure	LipiFlow Treatment Treatment with LipiFlow device
Overall Study STARTED	50
Overall Study COMPLETED	49
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	LipiFlow Treatment Treatment with LipiFlow device
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Evaluation of Screening Methods for Treatment of Meibomian Gland Dysfunction

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	LipiFlow Treatment n=50 Participants Treatment with LipiFlow device
Age Continuous	49.8 years STANDARD_DEVIATION 15.9 • n=5 Participants
Sex: Female, Male Female	35 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 4 Weeks

Population: Results presented are for the Intent to Treat population.

Analysis of association between Baseline Meibomian Gland Expression Score and Total Meibomian Gland Score at 4 Weeks. Success was defined by demonstration of a statistically significant (p\<0.05) association between the screening method and outcome. Meibomian gland expression sum scores range from 0 to 60 with a higher score reflecting less meibomian gland dysfunction. Total meibomian gland scores range from 0 to 45 with a higher score reflecting less meibomian gland dysfunction.

Outcome measures

Outcome measures
Measure	LipiFlow Treatment n=50 Participants Treatment with LipiFlow device
Association Between Screening Methods (Meibomian Gland Expression) and Treatment Effectiveness Outcomes (Total Meibomian Gland Score)	0.4816 Correlation coefficient

Adverse Events

LipiFlow Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Christy Stevens, OD

TearScience, Inc. (formerly Kolis Scientific)

Phone: 919-459-4815

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place