Evaluation of a Johnson & Johnson Vision Care Investigational Contact Lens Compared to a Marketed Monthly Replacement Contact Lens

• Sponsor: Johnson & Johnson Vision Care, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02515994
• Collaborator: (none)
• Enrollment: 224
• Locations: 10
• Arms: 2
• Duration (Months): 4
• Patients Per Site: 22.4
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

Randomized, double-masked, controlled, 2-arm parallel group, multi-site, 3-month dispensing study of Johnson & Johnson Vision Care, Inc. (JJVCI) Investigational contact lens, compared with a marketed, monthly replacement contact lens. Subjects will wear the JJVCI investigational contact lenses on a daily wear basis.

Condition or Disease	Intervention/Treatment	Phase
Refractive Error	Device: senofilcon C; Device: comfilcon A	N/A

Detailed Description

Objective of the study is to demonstrate the safety and efficacy of the JJVCI investigational contact lens by comparison to the marketed, monthly replacement contact lens, both worn for thirty days on a daily wear modality.

Study Design

• Study Type: Interventional
• Actual Enrollment: 224 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Nov 1, 2015
• Actual Study Completion Date: Nov 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: senofilcon C JJVCI investigational contact lens daily wear replacement.	Device: senofilcon C; Investigational contact lens
Active Comparator: comfilcon A Marketed contact lens daily wear replacement.	Device: comfilcon A; Marketed Monthly Replacement Lens (Control); Other Names: Biofinity

Outcome Measures

Primary Outcome Measures

1. Slit Lamp Findings [Up to 3 Month Follow-up]

   Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.

2. Visual Acuity [Up to 3 month Follow-up]

   Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.

Secondary Outcome Measures

1. Symptoms [Up to 3 month Follow-up]

   Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item "Experienced Eye Symptoms or Problems?" were reported.

2. Average Wear Time [3 month Follow-up]

   Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported.

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 read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.

• The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.

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

• The subject's vertex corrected spherical equivalent distance refraction must be in the range of -1.00 to -6.00 in each eye.

• The subject's refractive cylinder must be ≤ 1.00 Diopters in each eye.

• The subject must have best corrected visual acuity of 20/25 or better in each eye.

• Subjects should own a wearable pair of spectacles.

• The subject must be an adapted frequent replacement daily wear spherical silicone hydrogel soft contact lens wearer in both eyes.

• The subject must have normal eyes (i.e., no ocular medications or infections of any type).

• Subjects must be able and willing to wear the study lenses at least 6 hours a day, a minimum of 4 days per week

Exclusion Criteria:

• Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).

• Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear. This may include, but not be limited to, diabetes, hyperthyroidism, recurrent herpes simplex/zoster, Sjögren's syndrome, xerophthalmia, acne rosacea, Stevens-Johnson syndrome, and immunosuppressive diseases or any infectious diseases (e.g. hepatitis, tuberculosis).

• Use of any of the following medications within 1 week prior to enrollment: oral retinoid isotretinoin (e.g. Accutane), oral tetracyclines, topical scopolamine, oral (e.g. Seldane, Chlor-Trimeton, and Benadryl) and ophthalmic antihistamines, oral phenothiazines (e.g., Haldol, Mellaril, Thorazine, Elavil, Pamelor, Compazine), oral and ophthalmic Beta-adrenergic blockers (e.g., Propranolol, Timolol, and Practolol), systemic steroids, and any prescribed or over the counter (OTC) ocular medication.

• Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.

• Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser in situ keratomileusis (LASIK), etc.).

• Any grade 2 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

• Any known hypersensitivity or allergic reaction to Optifree®Puremoist® multi-purpose care solution or Eye-Cept® rewetting drop solution

• Any ocular infection, allergy or clinically significant ocular disease (e.g. corneal edema, uveitis, severe keratoconjunctivitis sicca, ocular hypertension), or ocular conditions (e.g. strabismus), which might interfere with the study.

• Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.

• Daily disposables, extended wear, monovision or multi-focal contact lens correction.

• Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.

• History of binocular vision abnormality or strabismus.

• Employee or relative of employees of sponsor or investigational clinic (e.g., Investigator, Coordinator, Technician)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vue Optical Boutique	Jacksonville	Florida	United States	32205
2	Omega Vision Center, PA / Sabal Eye Care	Longwood	Florida	United States	32779
3	Eyecare Associates	Bloomington	Illinois	United States	61701
4	Advantage Eyecare Associates, LLC	Broadway Pittsburg	Kansas	United States	66762
5	Dr. Debbie H. Kim, OD	Closter	New Jersey	United States	07624
6	Sacco Eye Group	Vestal	New York	United States	13850
7	Pickens Family Eye Care	Pickens	South Carolina	United States	29671
8	Premier Vision	Amarillo	Texas	United States	79119
9	William J. Bogus OD	Salt Lake City	Utah	United States	84106
10	Timothy R. Poling, OD	Salem	Virginia	United States	24153

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: NCT02515994
• Other Study ID Numbers: CR-5726
• First Posted: Aug 5, 2015
• Last Update Posted: Jul 15, 2016
• Last Verified: Jun 1, 2016

• Additional relevant MeSH terms: Refractive Errors

Study Results

Participant Flow

Pre-assignment Detail	A total of 224 subjects were enrolled in this study. Of the enrolled subjects 3 did not meet the eligibility criteria and 221 were dispensed a study lens. Of the dispensed subjects 204 completed the study while 17 subjects were discontinued.

Arm/Group Title	Senofilcon C	Comfilcon A
Arm/Group Description	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
Period Title: Overall Study
STARTED	109	112
COMPLETED	99	105
NOT COMPLETED	10	7

Baseline Characteristics

Arm/Group Title	Senofilcon C	Comfilcon A	Total
Arm/Group Description	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.	Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.	Total of all reporting groups
Overall Participants	109	112	221
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	30.4 (7.26)	30.9 (7.33)	30.7 (7.24)
Sex: Female, Male (Count of Participants)
Female	79 72.5%	71 63.4%	150 67.9%
Male	30 27.5%	41 36.6%	71 32.1%
Region of Enrollment (participants) [Number]
United States	109 100%	112 100%	221 100%

Outcome Measures

1. Primary Outcome

Title	Slit Lamp Findings
Description	Slit Lamp Findings (SLF) were assessed using a biomicroscope and was graded using the FDA grading scale (Grade: 0, 1,2, 3 and 4) with grade 0 represents the absence of findings and 1 to 4 representing successively worse findings (i.e. Grade 1 = trace, Grade 2 = Mild, Grade 3 = moderate and Grade 4 = severe). This was performed on each subject eye at 1-, 2-, 4-, 8- and 12-week follow-up evaluations. The data was then dichotomized into two groups. Those with grade 3 or higher and those with grade 2 or lower. The number of SLF with grade 3 or higher by eye was reported.
Time Frame	Up to 3 Month Follow-up

Outcome Measure Data

Analysis Population Description

All subjects that were dispensed a study lens.

Arm/Group Title	Senofilcon C	Comfilcon A
Arm/Group Description	Subjects that wore the senofilcon C lens throughout the entire study.	Subjects that wore the comfilcon A lens throughout the entire study.
Measure Participants	109	112
Measure Subject Eyes	218	224
Number [Eyes]	3	2

2. Primary Outcome

Title	Visual Acuity
Description	Monocular best-corrected visual acuity was assessed using a Snellen (ETDRS) on a LogMAR scale at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks for each subject and subject eye. LogMAR visual acuity was evaluated under high luminance high contrast condition. The average visual acuity across all visits was reported.
Time Frame	Up to 3 month Follow-up

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Senofilcon C	Comfilcon A
Arm/Group Description	Subjects that wore the senofilcon C lens throughout the entire study.	Subjects that wore the comfilcon A lens throughout the entire study.
Measure Participants	99	105
Measure Number of Observations	198	210
Mean (Standard Deviation) [LogMAR]	-0.11 (0.073)	-0.12 (0.073)

3. Secondary Outcome

Title	Symptoms
Description	Ocular symptoms, problems and complaints were assessed by a questionnaire at each visit 1-, 2-, 3-, 4-, 8- and 12- week follow-ups. The number of events where subjects that responded 'yes' to the item "Experienced Eye Symptoms or Problems?" were reported.
Time Frame	Up to 3 month Follow-up

Outcome Measure Data

Analysis Population Description

All subjects that were dispensed a study lens.

Arm/Group Title	Senofilcon C	Comfilcon A
Arm/Group Description	Subjects that wore the senofilcon C lens throughout the entire study.	Subjects that wore the comfilcon A lens throughout the entire study.
Measure Participants	109	112
Measure Subject Eyes	218	224
Number [Eyes]	153	225

4. Secondary Outcome

Title	Average Wear Time
Description	Average Wear time was recorded for each subject at each follow-up visit 1-, 2-, 4-, 8- and 12- weeks. The average wear time across all visits was reported.
Time Frame	3 month Follow-up

Outcome Measure Data

Analysis Population Description

Subjects that completed all study visits without a major protocol deviation.

Arm/Group Title	Senofilcon C	Comfilcon A
Arm/Group Description	Subjects that wore the senofilcon C lens throughout the entire study.	Subjects that wore the comfilcon A lens throughout the entire study.
Measure Participants	99	105
Mean (Standard Deviation) [Hours per day]	14.88 (1.713)	14.90 (1.576)

Adverse Events

Time Frame	Throughout the entire duration of the study. Approximately 5 months.
Arm/Group Title	Senofilcon C		Comfilcon A
Arm/Group Description	Subjects that were randomized to receive the senofilcon C lens throughout the duration of the study.		Subjects that were randomized to receive the comfilcon A lens throughout the duration of the study.
All Cause Mortality
	Senofilcon C		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Senofilcon C		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/109 (0%)		0/112 (0%)
Other (Not Including Serious) Adverse Events
	Senofilcon C		Comfilcon A
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	5/109 (4.6%)		5/112 (4.5%)
Eye disorders
Non-Significant Ocular Event	5/109 (4.6%)	5	5/112 (4.5%)	5

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.