Trial Outcomes & Findings for Vistakon Investigational Lens Worn as a Single Use Daily Wear (NCT NCT01031004)

NCT ID: NCT01031004

Last Updated: 2018-06-19

Results Overview

Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: after 1 month of lens wear
• Results posted on: 2018-06-19

Participant Flow

Participant milestones

Measure	Narafilcon B single use, daily wear contact lens	Etafilcon A contact lens worn as single use, daily wear
Overall Study STARTED	25	25
Overall Study COMPLETED	24	24
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Measure	Narafilcon B single use, daily wear contact lens	Etafilcon A contact lens worn as single use, daily wear
Overall Study Protocol Violation	0	1
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Vistakon Investigational Lens Worn as a Single Use Daily Wear

Baseline characteristics by cohort

Measure	Narafilcon B n=25 Participants single use, daily wear contact lens	Etafilcon A n=25 Participants contact lens worn as single use, daily wear	Total n=50 Participants Total of all reporting groups
Age, Continuous	29.2 years STANDARD_DEVIATION 8.19 • n=5 Participants	29.2 years STANDARD_DEVIATION 8.08 • n=7 Participants	29.2 years STANDARD_DEVIATION 8.13 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Region of Enrollment United States	25 participants n=5 Participants	25 participants n=7 Participants	50 participants n=5 Participants

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe. This outcome measures the number of eyes that had corneal edema graded 2 or higher at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Corneal Edema	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 month of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Number of eyes with corneal edema graded 2 or higher at the 1 month visit. Investigators examined subjects using a slit lamp and the following scale: 0=none, 1=trace, 2=mild, 3=moderate, 4=severe.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Corneal Edema at Month 1	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Corneal Neovascularization	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 month of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal neovascularization graded 2 or higher at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Corneal Neovascularization	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Corneal Staining	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 month of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had corneal staining graded 2 or higher at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Corneal Staining	1 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Injection	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 month of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had injection graded 2 or higher at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Injection	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Tarsal Abnormalities	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 month of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and the following scale:0=none, 1=trace, 2=mild, 3=moderate, 4= severe. This outcome measures the number of eyes that had tarsal abnormalities graded 2 or higher at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Tarsal Abnormalities	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Infiltrates	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 month of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Investigators examined subjects using a slit lamp and recorded the presence or absence of infiltrates. This outcome measures the number of eyes that had infiltrates present at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Slit Lamp Findings - Infiltrates	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Number of eyes in which subjects reported lens-related symptoms after 1 week of lens wear.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Subject Reported Symptoms	15 eyes	8 eyes

PRIMARY outcome

Timeframe: after 1 month of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Number of eyes in which subjects reported lens-related symptoms after 1 month of lens wear.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Subject Reported Symptoms	14 eyes	5 eyes

PRIMARY outcome

Timeframe: after 1 week

Population: This analysis includes all participants that completed the study per protocol.

Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-week visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Visual Acuity (VA)	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 month

Population: This analysis includes all participants that completed the study per protocol.

Investigators assessed visual acuity per eye using a Snellen visual acuity chart. This outcome measures the number of eyes, wearing vision correction, that measured visual acuity worse than 20/30 at the 1-month visit.

Outcome measures

Measure	Narafilcon B n=48 eyes single use, daily wear contact lens	Etafilcon A n=48 eyes contact lens worn as single use, daily wear
Visual Acuity (VA)	0 eyes	0 eyes

PRIMARY outcome

Timeframe: after 1 week of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Outcome measures

Measure	Narafilcon B n=24 Participants single use, daily wear contact lens	Etafilcon A n=24 Participants contact lens worn as single use, daily wear
Average Wear Time	13.9 hours per day Standard Deviation 1.91	13.7 hours per day Standard Deviation 2.41

PRIMARY outcome

Timeframe: after 1 month of lens wear

Population: This analysis includes all participants that completed the study per protocol.

Outcome measures

Measure	Narafilcon B n=24 Participants single use, daily wear contact lens	Etafilcon A n=24 Participants contact lens worn as single use, daily wear
Average Wear Time	13.6 hours per day Standard Deviation 2.33	13.8 hours per day Standard Deviation 2.24

Adverse Events

Narafilcon B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Etafilcon A

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

John Buch/Principal Research Optometrist

Vistakon

Phone: 904-443-1707

Results disclosure agreements

• Principal investigator is a sponsor employee The PI may not publish, divulge, reveal, disclose, or use the data and or results of the study without prior written consent of Vistakon.
• Publication restrictions are in place

Restriction type: OTHER