CompletedNCT02212301Updated Oct 28, 2016Results posted

Comparison of Two Marketed Lenses in a Controlled Environment

An interventional study of senofilcon A and lotrafilcon B in Eye Dryness, sponsored by Johnson & Johnson Vision Care, Inc.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-28.

Sponsored by Johnson & Johnson Vision Care, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 45
Allocation: Randomized
Ages: 18 Years to 50 Years
Sex: All

Study summary

This study is comparing two silicone hydrogel contact lenses in a controlled environment for identification of characteristics associated to vision.

Conditions studied

Eye Dryness

In context

Lead sponsor

Johnson & Johnson Vision Care, Inc. is the lead sponsor of 220 studies on the registry; 2 are open to participants now.

Of its 110 completed or terminated interventional studies of FDA-regulated products, 101 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 50 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

The subject must be 18 years of age and less than 51 years of age;
The subject must have read and understood the Participant Information Sheet;
The subject must have read, signed and dated the Informed Consent;
The subject must be a current planned replacement soft contact lens wearer;
The subject must be a regular user of devices (computer, tablet and/or smart phone) for a minimum average of 5 ± 1 hours per day in a typical week
The subject must have a refractive error within the range of correction of both study contact lenses;
The subject must have a best-corrected visual acuity of 6/9 (20/30, 0.18 LogMAR) or better in each eye;
The subject must demonstrate an acceptable fit with both study contact lenses;
The subject must agree to wear their contact lenses as directed for the duration of the study (every day or for at least a minimum of five days per week for a minimum of six hours per day and be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule;
The subject must have normal eyes with the exception of the need for visual correction.

Exclusion criteria

Exclusion Criteria:

Any known sensitivity or intolerance to any of the contact lenses or adjunct products to be used.
Monocular vision (only one eye with functional vision or only one eye fitted with contact lenses).
Use of systemic or ocular concomitant medications which, as determined by the investigator, might contraindicate or interfere with contact lens wear.
Ocular anterior segment infection, inflammation, abnormality, or active disease, which would contraindicate contact lens wear.
Any moderate or severe ocular condition observed during slit lamp examination at the enrollment visit.
A history of herpetic keratitis, ocular surgery or irregular cornea(s).
Known pregnancy or lactation during the study period.
Enrollment of investigator's office staff, relatives, or members of their respective households.
Participation in any clinical trial within 30 days of the enrollment visit.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 45 participants (actual)

Study arms

Active comparator
senofilcon A / lotrafilcon B
Subjects were randomized to one of two lens wear sequences. Subjects randomized to this sequence first wore the senofilcon A contact lens and then wore the lotrafilcon B contact lens.
Device: senofilcon A · Device: lotrafilcon B
Active comparator
lotrafilon B/ senofilcon A
Subjects were randomized to one of two lens wear sequences. Subjects randomized to this sequence first wore the lotrafilcon B contact lens and then wore the senofilcon A contact lens
Device: senofilcon A · Device: lotrafilcon B

Interventions

Devicesenofilcon A
Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
Devicelotrafilcon B
Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.

What researchers measure

Primary outcomes

Tear Film Kinetics
The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.
Time frame: 8 hour post insertion
Time Controlled Visual Acuity
The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17" LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3" LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.
Time frame: 8 hours post insertion

Results

Posted Sep 27, 2016

Participant flow

Period 1

Participant flow — Period 1
Milestone	Senofilcon A/ Lotrafilcon B	Lotrafilcon B / Senofilcon A
Started	21	22
Completed	21	21
Not completed	0	1
Withdrew: Lost to follow-up	0	1

Period 2

Participant flow — Period 2
Milestone	Senofilcon A/ Lotrafilcon B	Lotrafilcon B / Senofilcon A
Started	21	21
Completed	21	21
Not completed	0	0

Outcome measures

PrimaryTear Film Kinetics

The non-invasive tear film break-up-time (NIBUT) is the time elapsed (in seconds) between eye opening after a blink, and the appearance of the first dark spot within the tear film when observed with the wide diffuse light source of the Tearscope. This measurement is indicative of the tear film stability and the on eye wettability of contact lenses.

Time frame:: 8 hour post insertion
Reported as:: Mean · Seconds

Tear Film Kinetics
Seconds	Senofilcon A	Lotrafilcon B
Tear Film Kinetics	5.590 ± 4.2705	6.941 ± 6.1257

PrimaryTime Controlled Visual Acuity

The Time Controlled Visual Acuity test is a proprietary test part of MG Vision Advanced Visual Performance Assessment. The test for distance vision is carried out at 4m under high contrast and dim luminance. The test is presented on a fast response 17" LCD screen (1280 by 1064). The test for intermediate vision is carried out at 64cm under high contrast dim luminance. The test was presented on a fast response 13.3" LCD screen (3200 by 1800). Visual acuity will be measured in a controlled environment using logMAR units.

Time frame:: 8 hours post insertion
Reported as:: Mean · LogMAR

Time Controlled Visual Acuity
LogMAR	Senofilcon A	Lotrafilcon B
Distance	-0.06 ± 0.092	-0.07 ± 0.075
Intermediate	0.07 ± 0.077	0.06 ± 0.074

Adverse events

Collected over Throughout the duration of the study. Approximately 1 month per subject.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Senofilcon A	—	0/43 (0%)	3/43 (7%)
Lotrafilcon B	—	0/43 (0%)	4/43 (9.3%)

Most frequent other events

Most frequent other events
Event	Senofilcon A	Lotrafilcon B
ColdGeneral disorders	3/43	4/43

Baseline characteristics

All subjects that were dispensed at least one study lens.

Age, Continuous
Age, Continuous(Years)	Dispensed Subjects
Mean	35.1 ± 7.78

Sex: Female, Male
Sex: Female, Male(Participants)	Dispensed Subjects
Female	29
Male	14

Region of Enrollment
Region of Enrollment(participants)	Dispensed Subjects
United Kingdom	43

Study locations

1 site

London, SW1E 6AU, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 28, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02212301
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Responsible party: Sponsor
First posted: Aug 8, 2014
Start date: Jul 2014
Primary completion: Dec 2014
Completion: Dec 2014
Results posted: Sep 27, 2016
Last update: Oct 28, 2016

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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