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).

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00241280
• Collaborator: (none)
• Enrollment: 504
• Locations: 25
• Arms: 2
• Duration (Months): 13
• Patients Per Site: 20.2
• Patients Per Site Per Month: 1.6

Study Details

Study Description

Brief Summary

Study in the US 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).

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: etafilcon A; Device: galyfilcon A	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 504 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Study Start Date: Sep 1, 2005
• Actual Primary Completion Date: Oct 1, 2006
• Actual Study Completion Date: Oct 1, 2006

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control etafilcon A contact lens being worn 7 days/6 nights.	Device: etafilcon A
Experimental: Test galyfilcon A contact lens being worn 7 days/6 nights.	Device: galyfilcon A

Outcome Measures

Primary Outcome Measures

1. Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40 [Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks]

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

2. Rate of Contact Lens Related Serious and Significant Events (SSE) [Throughout the duration of the study (1 Year)]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• The subject must be at least 18 years of age.

• The subject must read and sign the statement of informed consent and be provided with a copy of the form.

• Minimum of 7 days of successful lens wear

• Contact lens prescription requiring between -1.00 to -6.00 D spherical power

• Less than 1.00 D of astigmatism in either eye

Exclusion Criteria:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Steven S. Grant, OD	Costa Mesa	California	United States	92626
2	Cole, Cole, and Krohn	Fresno	California	United States	93704
3	Fukai and Associates	Louisville	Colorado	United States	80027
4	Peter C. Donshik, MD	Bloomfield	Connecticut	United States	06002
5	Dr. Ted Brink and Associates	Jacksonville	Florida	United States	32256
6	Jack J. Yager, OD	Orlando	Florida	United States	32803
7	Clayton Eye Center	Morrow	Georgia	United States	30260
8	Eyecare Associates	Bloomington	Illinois	United States	61701
9	Drs. Hawks, Besler & Rogers	Gardner	Kansas	United States	66030
10	Lee Rigel	East Lansing	Michigan	United States	48823
11	Univ Missouri at St. Louis, College of Optometry	St. Louis	Missouri	United States	63121
12	InSight Eyecare	Warrensburg	Missouri	United States	64093
13	Drs. Quinn, Quinn and Associates	Athens	Ohio	United States	45701
14	Central Ohio Eyecare	Columbus	Ohio	United States	43202
15	Kenji Hamada, OD	Grants Pass	Oregon	United States	97526
16	West Hills Vision Center	Moon Township	Pennsylvania	United States	15108
17	Kenneth A. Young, OD	Brentwood	Tennessee	United States	37027
18	Gary W. Jerkins, MD	Nashville	Tennessee	United States	37205
19	Premier Vision	Amarillo	Texas	United States	79119
20	Charles Wegman, OD	Carrollton	Texas	United States	75006
21	Wishnow-Sugar Vision Group	Katy	Texas	United States	77450
22	First Eye Care Plano	Plano	Texas	United States	75023
23	Dr. William Bogus	Salt Lake City	Utah	United States	84106
24	Scott Jens, OD	Middleton	Wisconsin	United States	53562
25	Snowy Range Vision Center	Laramie	Wyoming	United States	82070

Sponsors and Collaborators

• Johnson & Johnson Vision Care, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Vision Care, Inc.
• ClinicalTrials.gov Identifier: NCT00241280
• Other Study ID Numbers: CR-1480
• First Posted: Oct 18, 2005
• Last Update Posted: Mar 24, 2016
• Last Verified: Feb 1, 2016

• Additional relevant MeSH terms: Myopia

Study Results

Participant Flow

Pre-assignment Detail	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.

Arm/Group Title	Control: Etafilcon A	Test: Galyfilcon A
Arm/Group Description	Subjects that were randomly assigned to wear Control lens.	Subjects that were randomly assigned to wear the Test lens.
Period Title: Overall Study
STARTED	247	254
COMPLETED	199	186
NOT COMPLETED	48	68

Baseline Characteristics

Arm/Group Title	Control: Etafilcon A	Test: Galyfilcon A	Total
Arm/Group Description	Subjects that were randomized to receive the Control lens etafilcon A	Subjects that were randomized to receive the Test lens galyfilcon A	Total of all reporting groups
Overall Participants	247	254	501
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	31.7	32.8	32.2
Sex: Female, Male (Count of Participants)
Female	150 60.7%	172 67.7%	322 64.3%
Male	97 39.3%	82 32.3%	179 35.7%
Race/Ethnicity, Customized (participants) [Number]
Asian	11 4.5%	10 3.9%	21 4.2%
White	203 82.2%	217 85.4%	420 83.8%
African-American	16 6.5%	13 5.1%	29 5.8%
Hispanic	12 4.9%	13 5.1%	25 5%
Asian-Indian	1 0.4%	1 0.4%	2 0.4%
Other	4 1.6%	0 0%	4 0.8%
Region of Enrollment (participants) [Number]
United States	247 100%	254 100%	501 100%

Outcome Measures

1. Primary Outcome

Title	Monocular Contact Lens Snellen Visual Acuity Worse Than 20/40
Description	Percentage of subject eyes reported with visual acuity worse than 20/40 at each study visit.
Time Frame	Follow-up Visits- 24 hr, 1, 4, 12, 24,36, and 52 weeks

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Control: Etafilcon A	Test: Galyfilcon A
Arm/Group Description	Subjects that were randomly assigned to wear the Control lens.	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.
Measure Participants	199	186
Measure Eyes	398	372
24-Hr. Follow-up, N=396, 370	0	0
1-week Follow-up, N=393, 366	0	0
4-week Follow-up, N=392, 370	0	0
12-week Follow-up, N=388, 370	0	0
24-week Follow-up, N=390, 370	0	.27
36-week Follow-up, N=390 , 365	0	0
52-week Follow-up, N=390, 368	0	0

2. Primary Outcome

Title	Rate of Contact Lens Related Serious and Significant Events (SSE)
Description	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.
Time Frame	Throughout the duration of the study (1 Year)

Outcome Measure Data

Analysis Population Description

All subjects that were dispensed a study lens.

Arm/Group Title	Control: Etafilcon A	Test: Galyfilcon A
Arm/Group Description	Subjects that were randomly assigned to wear the Control lens.	Subjects that were randomly assigned to wear the Test lens.
Measure Participants	247	254
Number [percentage of Subjects]	2.4	5.9

Adverse Events

Time Frame	Throughout the duration of the Study (1 Year)
Arm/Group Title	Control: Etafilcon A		Test: Galyfilcon A
Arm/Group Description	Subjects that were randomly assigned to wear Control lens.		Subjects that were randomly assigned to wear Test lens.
All Cause Mortality
	Control: Etafilcon A		Test: Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Control: Etafilcon A		Test: Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/247 (0%)		1/254 (0.4%)
Eye disorders
IRITIS	0/247 (0%)	0	1/254 (0.4%)	1
Other (Not Including Serious) Adverse Events
	Control: Etafilcon A		Test: Galyfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/247 (9.3%)		43/254 (16.9%)
Eye disorders
Conjunctivitis	21/247 (8.5%)	35	31/254 (12.2%)	48
CLPU	2/247 (0.8%)	2	12/254 (4.7%)	13

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.