Trial Outcomes & Findings for Contact Lens Comfort Relative to Meibomian Gland Status (NCT NCT01819194)

Results Overview

CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

64 participants

Primary outcome timeframe

Post 3 days of wear

Results posted on

2018-06-19

Participant Flow

A total of 64 subjects were enrolled in this study. Of the enrolled subjects 2 did not meet the eligibility criteria and 62 were dispensed a study lens. Of the dispensed subjects 60 completed the study and 2 were discontinued.

Participant milestones

Participant milestones
Measure	Overall Subjects only wore one lens: senofilcon A, 38% water. Subjects, were enrolled and screened per inclusion/exclusion criteria.
Overall Study STARTED	62
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Overall Subjects only wore one lens: senofilcon A, 38% water. Subjects, were enrolled and screened per inclusion/exclusion criteria.
Overall Study Loss of study articles	2

Baseline Characteristics

Contact Lens Comfort Relative to Meibomian Gland Status

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=64 Participants All subjects that were dispensed the study lens.
Age, Continuous	24.53 years STANDARD_DEVIATION 3.050 • n=39 Participants
Sex: Female, Male Female	49 Participants n=39 Participants
Sex: Female, Male Male	15 Participants n=39 Participants
Region of Enrollment United States	64 participants n=39 Participants

PRIMARY outcome

Timeframe: Post 3 days of wear

Population: Subjects are those who were enrolled, randomized, and completed the study per protocol.

CLUE is survey that is used to assess subjective comfort of the test article. The higher the score the better on a range of 0 to 120.

Outcome measures

Outcome measures
Measure	Senofilcon A, 38% Water n=60 Participants Senofilcon A, 38% water
Comfort as Measured by the Contact Lens Users Experience Questionnaire (CLUE)	58.67 units on a scale Standard Deviation 18.430

PRIMARY outcome

Timeframe: Post 3 days of wear

Population: Subjects analyzed are those who enrolled, randomized, and completed the study per protocol.

Meibomian Gland Dysfunction (MGD) as measured using the MGD 0 - 11 scale translated into grades 0 to 3 where 0 refers to absence of markers.

Outcome measures

Outcome measures
Measure	Senofilcon A, 38% Water n=120 Eyes Senofilcon A, 38% water
Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale Grade 0	0 eyes
Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale Grade 1	88 eyes
Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale Grade 2	32 eyes
Meibbomian Gland Dysfunction (MGD)as Measured by MGD Scale Grade 3	0 eyes

Adverse Events

Senofilcon A, 38% Water

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

Daria Wicks

Vistakon

Phone: 904-443-1391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60