Trial Outcomes & Findings for Study Intended to Evaluate the Safety and Effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) Contact Lens for Use on an Extended-wear Basis for up to 7 Days (6 Nights). (NCT NCT00241280)

NCT ID: NCT00241280

Last Updated: 2016-03-24

Results Overview

Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 504 participants
• Primary outcome timeframe: Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks
• Results posted on: 2016-03-24

Participant Flow

504 Subjects were enrolled in this study. 1 subject did not meet the eligibility. 2 subjects were randomized to the control lens group, but were not dispensed lenses. 247 subjects were randomized to the Control lens and 254 subjects were randomized to the Test lens.

Participant milestones

Measure	Control: Etafilcon A Subjects that were randomly assigned to wear Control lens.	Test: Galyfilcon A Subjects that were randomly assigned to wear the Test lens.
Overall Study STARTED	247	254
Overall Study COMPLETED	199	186
Overall Study NOT COMPLETED	48	68

Reasons for withdrawal

Measure	Control: Etafilcon A Subjects that were randomly assigned to wear Control lens.	Test: Galyfilcon A Subjects that were randomly assigned to wear the Test lens.
Overall Study Adverse Event	2	6
Overall Study Discomfort	11	16
Overall Study Pregnancy	1	5
Overall Study Lost to Follow-up	5	8
Overall Study Withdrawal by Subject	7	4
Overall Study Protocol Violation	4	10
Overall Study Relocation	4	4
Overall Study Unsatisfactory Physiological Response	1	1
Overall Study Unsatisfactory Visual Response	1	1
Overall Study Diabetic	1	0
Overall Study Subject Ineligible/Dispensed	9	6
Overall Study Dispensed incorrect test article	1	2
Overall Study Unacceptable Fit	0	1
Overall Study Scheduling Conflict	0	2
Overall Study History of Ocular Surgery	0	1
Overall Study Coating on Lens	1	0
Overall Study Excessive Dryness	0	1

Baseline Characteristics

Study Intended to Evaluate the Safety and Effectiveness of a Johnson & Johnson Vision Care Inc, (JJVCI) Contact Lens for Use on an Extended-wear Basis for up to 7 Days (6 Nights).

Baseline characteristics by cohort

Measure	Control: Etafilcon A n=247 Participants Subjects that were randomized to receive the Control lens etafilcon A	Test: Galyfilcon A n=254 Participants Subjects that were randomized to receive the Test lens galyfilcon A	Total n=501 Participants Total of all reporting groups
Age, Continuous	31.7 years n=5 Participants	32.8 years n=7 Participants	32.2 years n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants	172 Participants n=7 Participants	322 Participants n=5 Participants
Sex: Female, Male Male	97 Participants n=5 Participants	82 Participants n=7 Participants	179 Participants n=5 Participants
Race/Ethnicity, Customized Asian	11 participants n=5 Participants	10 participants n=7 Participants	21 participants n=5 Participants
Race/Ethnicity, Customized White	203 participants n=5 Participants	217 participants n=7 Participants	420 participants n=5 Participants
Race/Ethnicity, Customized African-American	16 participants n=5 Participants	13 participants n=7 Participants	29 participants n=5 Participants
Race/Ethnicity, Customized Hispanic	12 participants n=5 Participants	13 participants n=7 Participants	25 participants n=5 Participants
Race/Ethnicity, Customized Asian-Indian	1 participants n=5 Participants	1 participants n=7 Participants	2 participants n=5 Participants
Race/Ethnicity, Customized Other	4 participants n=5 Participants	0 participants n=7 Participants	4 participants n=5 Participants
Region of Enrollment United States	247 participants n=5 Participants	254 participants n=7 Participants	501 participants n=5 Participants

PRIMARY outcome

Timeframe: Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks

Population: The analysis population consists of subjects that completed all study visits, without a major protocol deviation. The analysis was conducted on these subject eyes.

Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.

Outcome measures

Measure	Control: Etafilcon A n=398 Eyes Subjects that were randomly assigned to wear the Control lens.	Test: Galyfilcon A n=372 Eyes Subjects that were randomly assigned to wear the Test lens. It was reported that for one subject eye, that the contact lens was dirty during the visual acuity testing.
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 24-Hr. Follow-up, N=396, 370	0 Percentage of Subjects Eyes	0 Percentage of Subjects Eyes
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 1-week Follow-up, N=393, 366	0 Percentage of Subjects Eyes	0 Percentage of Subjects Eyes
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 4-week Follow-up, N=392, 370	0 Percentage of Subjects Eyes	0 Percentage of Subjects Eyes
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 12-week Follow-up, N=388, 370	0 Percentage of Subjects Eyes	0 Percentage of Subjects Eyes
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 24-week Follow-up, N=390, 370	0 Percentage of Subjects Eyes	.27 Percentage of Subjects Eyes
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 36-week Follow-up, N=390 , 365	0 Percentage of Subjects Eyes	0 Percentage of Subjects Eyes
Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 52-week Follow-up, N=390, 368	0 Percentage of Subjects Eyes	0 Percentage of Subjects Eyes

PRIMARY outcome

Timeframe: Throughout the duration of the study (1 Year)

Population: All subjects that were dispensed a study lens.

The number of Contact-Lens related Serious and Significant Adverse Events were reported for each study lens. The incidence of rates of contact-lens related SSEs were calculated as (# of subjects that experienced an event)/(total # subjects). If there were multiple diagnostic findings, the event was categorized under the highest event level diagnostic.

Outcome measures

Measure	Control: Etafilcon A n=247 Participants Subjects that were randomly assigned to wear the Control lens.	Test: Galyfilcon A n=254 Participants Subjects that were randomly assigned to wear the Test lens. It was reported that for one subject eye, that the contact lens was dirty during the visual acuity testing.
Rate of Contact Lens Related Serious and Significant Events (SSE)	2.4 percentage of Subjects	5.9 percentage of Subjects

Adverse Events

Control: Etafilcon A

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Test: Galyfilcon A

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control: Etafilcon A n=247 participants at risk Subjects that were randomly assigned to wear Control lens.	Test: Galyfilcon A n=254 participants at risk Subjects that were randomly assigned to wear Test lens.
Eye disorders IRITIS	0.00% 0/247 • Throughout the duration of the Study (1 Year)	0.39% 1/254 • Number of events 1 • Throughout the duration of the Study (1 Year)

Other adverse events

Measure	Control: Etafilcon A n=247 participants at risk Subjects that were randomly assigned to wear Control lens.	Test: Galyfilcon A n=254 participants at risk Subjects that were randomly assigned to wear Test lens.
Eye disorders Conjunctivitis	8.5% 21/247 • Number of events 35 • Throughout the duration of the Study (1 Year)	12.2% 31/254 • Number of events 48 • Throughout the duration of the Study (1 Year)
Eye disorders CLPU	0.81% 2/247 • Number of events 2 • Throughout the duration of the Study (1 Year)	4.7% 12/254 • Number of events 13 • Throughout the duration of the Study (1 Year)

Additional Information

David C. Turner, Ph.D. GLOBAL PLATFORM SR DIRECTOR, R&D

Johnson & Johnson Vision Care, Inc.

Phone: 904-443-3500

Email: DTURNER2@its.jnj.com

Results disclosure agreements

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

Restriction type: GT60