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Trial Outcomes & Findings for Assessment of Contact Lens Wettability Using Wavefront Aberrometry (NCT NCT02349438)

NCT ID: NCT02349438

Last Updated: 2018-06-19

Results Overview

Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

25 participants

Primary outcome timeframe

2 hours post insertion

Results posted on

2018-06-19

Participant Flow

A total of 25 subjects were enrolled into this study. Of the enrolled subjects 4 did not meet the eligibility criteria and 21 were dispensed study lenses. Of the dispensed subjects all 21 completed the study.

Participant milestones

Participant milestones
Measure
Senofilcon A/Lotrafilcon B
Subjects that were randomized to receive the senofilcon A lens first and then to receive the lotrafilcon B lens.
Lotrafilcon B/Senofilcon A
Subjects that were randomized to receive the lotrafilcon B lens first and then to receive the senofilcon A lens.
Period 1
STARTED
11
10
Period 1
COMPLETED
11
10
Period 1
NOT COMPLETED
0
0
Period 2
STARTED
11
10
Period 2
COMPLETED
11
10
Period 2
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Assessment of Contact Lens Wettability Using Wavefront Aberrometry

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Dispensed
n=21 Participants
All subjects that were dispensed at least 1 study lens during the course of the study.
Age, Continuous
23.1 years
STANDARD_DEVIATION 5.43 • n=5 Participants
Sex: Female, Male
Female
15 Participants
n=5 Participants
Sex: Female, Male
Male
6 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
14 participants
n=5 Participants
Race/Ethnicity, Customized
White
7 participants
n=5 Participants
Region of Enrollment
Australia
21 participants
n=5 Participants

PRIMARY outcome

Timeframe: 2 hours post insertion

Population: All subjects that have completed all study visits.

Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=21 Participants
Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
Lotrafilcon B
n=21 Participants
Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking
0.159 microns
Standard Deviation 0.0662
0.142 microns
Standard Deviation 0.0605

PRIMARY outcome

Timeframe: 2 hours post insertion

Population: All subjects that have completed all study visits.

Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=21 Participants
Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
Lotrafilcon B
n=21 Participants
Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink
0.165 microns
Standard Deviation 0.0857
0.146 microns
Standard Deviation 0.0567

PRIMARY outcome

Timeframe: 2 hours post insertion

Population: All subjects that have completed all study visits.

Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.

Outcome measures

Outcome measures
Measure
Senofilcon A
n=21 Participants
Subjects that wore the senofilcon A lens in either the 1st or 2nd period of the study.
Lotrafilcon B
n=21 Participants
Subject that wore the lotrafilcon B in either the 1st or 2nd period of the study.
Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink
0.125 microns
Standard Deviation 0.0559
0.132 microns
Standard Deviation 0.0511

Adverse Events

Senofilcon A

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Lotrafilcon B

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

Chantal Coles-Brennan, PRINCIPAL RESEARCH OPTOMETRIST

Johnson & Johnson Vision Care Inc.

Phone: 904-443-3449

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60