Trial Outcomes & Findings for Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses (NCT NCT01482819)

Results Overview

measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

after 8 hours of lens wear

Results posted on

2018-06-19

Participant Flow

Participant milestones

Participant milestones
Measure	All Subjects Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
Overall Study STARTED	21
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
Overall Study Lost to Follow-up	2

Baseline Characteristics

Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=21 Participants Twenty-one subjects were enrolled, and 19 subjects completed the study per protocol. Two subjects were discontinued. There were no ineligible subjects.
Age, Continuous	23.7 years STANDARD_DEVIATION 6.11 • 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	5 participants n=5 Participants
Race/Ethnicity, Customized Multiple	16 participants n=5 Participants
Region of Enrollment Australia	21 participants n=5 Participants

PRIMARY outcome

Timeframe: after 8 hours of lens wear

Population: Subjects who were enrolled, randomized, and completed the study. One eye from each subject was measured.

measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)

Outcome measures

Outcome measures
Measure	Spectacles n=19 eyes No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.	Galyfilcon A Plus n=19 eyes Test article	Galyfilcon A n=19 eyes test article	Lotrafilcon A n=19 eyes test article	Polymacon n=19 eyes test article
Corneal Swelling	569.42 microns Standard Deviation 36.0709	574.64 microns Standard Deviation 39.7804	575.57 microns Standard Deviation 37.6229	578.99 microns Standard Deviation 41.4960	573.79 microns Standard Deviation 36.1644

PRIMARY outcome

Timeframe: after 8 hours of lens wear

Population: Subjects who were enrolled, randomized, and completed the study.

grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.

Outcome measures

Outcome measures
Measure	Spectacles n=38 eyes No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.	Galyfilcon A Plus n=38 eyes Test article	Galyfilcon A n=40 eyes test article	Lotrafilcon A n=40 eyes test article	Polymacon n=38 eyes test article
Limbal Redness	0.66 units on a scale Standard Deviation 0.2479	0.83 units on a scale Standard Deviation 0.3023	0.77 units on a scale Standard Deviation 0.3085	0.91 units on a scale Standard Deviation 0.3087	1.14 units on a scale Standard Deviation 0.3363

PRIMARY outcome

Timeframe: after 20 minutes of lens wear

Population: Subjects who were enrolled, randomized and completed the study.

0 to 100% of area; measured as a percentage of corneal area with blebs.

Outcome measures

Outcome measures
Measure	Spectacles n=40 eyes No lenses, glasses wear only, testing is done on open eye once glasses are removed. Acted as a negative control.	Galyfilcon A Plus n=38 eyes Test article	Galyfilcon A n=40 eyes test article	Lotrafilcon A n=40 eyes test article	Polymacon n=38 eyes test article
Endothelia Blebs	4.97 percentage of area Standard Deviation 3.3703	8.86 percentage of area Standard Deviation 3.9396	10.93 percentage of area Standard Deviation 6.6020	10.31 percentage of area Standard Deviation 6.6747	8.50 percentage of area Standard Deviation 3.6000

Adverse Events

All Subjects

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, Senior Clinical Research Manager

Johnson & Johnson Vision Care

Phone: 904-443-1391

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60