Trial Outcomes & Findings for Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens (NCT NCT01192542)

NCT ID: NCT01192542

Last Updated: 2018-06-19

Results Overview

Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 39 participants
• Primary outcome timeframe: Post lens insertion (baseline)
• Results posted on: 2018-06-19

Participant Flow

There were 39 enrolled, with one screen failure prior to randomization, leaving 38 starting and completing the study.

Participant milestones

Measure	Galyfilcon A Prototype Lens/Enfilcon A Lens The galyfilcon A prototype contact lens worn daily for 6-8 days first then the enfilcon A contact lens worn daily for 6-8 days second.	Enfilcon A Lens/Galyfilcon A Prototype Lens The enfilcon A contact lens worn daily for 6-8 days first then the galyfilcon A prototype contact lens worn daily for 6-8 days second.
Period 1 STARTED	18	20
Period 1 COMPLETED	18	20
Period 1 NOT COMPLETED	0	0
Period 2 STARTED	18	20
Period 2 COMPLETED	18	20
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Evaluation of a New Galyfilcon A Lens Prototype and Enfilcon A Lens

Baseline characteristics by cohort

Measure	All Subjects n=39 Participants All subjects who enrolled in the study.
Age, Continuous	28.2 years STANDARD_DEVIATION 6.58 • n=5 Participants
Sex: Female, Male Female	26 Participants n=5 Participants
Sex: Female, Male Male	13 Participants n=5 Participants
Region of Enrollment United States	39 participants n=5 Participants

PRIMARY outcome

Timeframe: Post lens insertion (baseline)

Population: Analysis was conducted on subjects who were enrolled, randomized, and successfully completed the study.

Snellen monocular visual acutity (VA) assessed by the Investigator and was converted to the LogMAR scale.

Outcome measures

Measure	Galyfilcon A Prototype Lens n=76 eyes Prototype silicone hydrogel lens.	Enfilcon A Lens n=76 eyes Marketed silicone hydrogel lens.
Monocular Visual Acuity Assessment	-0.05 logMAR Standard Error 0.0317	-0.04 logMAR Standard Error 0.0317

PRIMARY outcome

Timeframe: Post lens insertion (baseline)

Population: Analysis was conducted on subjects who enrolled, were randomized, and successfully complete the study per protocol.

Snellen binocular visual acuity assessed by the Investigator and was converted to the LogMAR scale. A value <0 implies clinically positive results, a value >0 implies clinically negative results

Outcome measures

Measure	Galyfilcon A Prototype Lens n=38 Participants Prototype silicone hydrogel lens.	Enfilcon A Lens n=38 Participants Marketed silicone hydrogel lens.
Binocular Visual Acuity	-0.08 LogMAR Standard Error 0.032	-0.08 LogMAR Standard Error 0.032

SECONDARY outcome

Timeframe: After 6-8 days of lens wear

Population: Analysis was conducted on subjects who successfully completed the study.

Limbal redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with limbal redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.

Outcome measures

Measure	Galyfilcon A Prototype Lens n=76 Eyes Prototype silicone hydrogel lens.	Enfilcon A Lens n=76 Eyes Marketed silicone hydrogel lens.
Limbal Redness of Grade 3 or Above	0 Subject Eyes	0 Subject Eyes

SECONDARY outcome

Timeframe: After 6-8 days of lens wear

Population: Analysis was conducted on subjects who successfully completed the study.

Bulbar redness was assessed using a 5-point slit lamp classification scale (5-Worst, 0-None). Only those eyes with bulbar redness grade >= 3 were reported for purposes of this analysis. Grades 3 -5 are considered to be part of the adverse events reporting.

Outcome measures

Measure	Galyfilcon A Prototype Lens n=76 Eyes Prototype silicone hydrogel lens.	Enfilcon A Lens n=76 Eyes Marketed silicone hydrogel lens.
Bulbar Redness of Grade 3 or Above	0 Subject Eyes	0 Subject Eyes

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

Brian Pall, O.D., M.S. F.A.A.O. Principal Research Optometrist

Johnson and Johnson Vision Care

Phone: 1 904 443-1290

Email: bpall@its.jnj.com

Results disclosure agreements

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