Eye DrynessNCT02212301

Comparison of Two Marketed Lenses in a Controlled Environment

A study testing senofilcon A and lotrafilcon B in people with Eye Dryness, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 18 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Eye Dryness
What is being tested?: senofilcon A and lotrafilcon B
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteUnited Kingdom
Study dates: Jul 2014to Dec 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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;

Show all 10Show fewer

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.

Who cannot join

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).

Show all 9Show fewer

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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Study site
London, SW1E 6AU

Other trials in United Kingdom

About this study

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

Conditions: Eye Dryness
Being tested: senofilcon A, lotrafilcon B
Medical subject headings: Xerophthalmia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

senofilcon ADevice
Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.
lotrafilcon BDevice
Each study contact lens will be worn as daily wear modality for a period of 2 weeks each.

Study groups in NCT02212301
Study group	Role	What they receive
senofilcon A / lotrafilcon B	Active comparator	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. Receives: Device: senofilcon A; Device: lotrafilcon B
lotrafilon B/ senofilcon A	Active comparator	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 Receives: Device: senofilcon A; Device: lotrafilcon B

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 8 hours post insertion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2014Dec 2014

First posted8 Aug 2014 (estimated)
Study startJul 2014
Primary completionDec 2014
Study completionDec 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Eye DrynessStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Participant
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02212301
Sponsor's protocol ID: CR-5573
Status last verified: Sep 2016
First submitted: 7 Aug 2014
Last updated: 28 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland

All Eye Dryness trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Two Marketed Lenses in a Controlled Environment
ClinicalTrials.gov ID: NCT02212301
Acronym / sponsor ID: CR-5573
Conditions: Eye Dryness
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: Jul 2014
Primary completion: Dec 2014 (actual)
Study completion: Dec 2014 (actual)
First posted: 8 Aug 2014 (estimated)
Results: Posted 27 Sep 2016

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
senofilcon A / lotrafilcon B	Active comparator	Device: senofilcon A, Device: lotrafilcon BSubjects 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.
lotrafilon B/ senofilcon A	Active comparator	Device: senofilcon A, Device: lotrafilcon BSubjects 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

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (10 listed)

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

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
senofilcon AEach study contact lens will be worn as daily wear modality for a period of 2 weeks each.	Device	lotrafilon B/ senofilcon A, senofilcon A / lotrafilcon B
lotrafilcon BEach study contact lens will be worn as daily wear modality for a period of 2 weeks each.	Device	lotrafilon B/ senofilcon A, senofilcon A / lotrafilcon B

Primary outcome

Tear Film Kinetics
Time frame: 8 hour post insertion
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 Controlled Visual Acuity
Time frame: 8 hours post insertion
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.

Results and safety

Results posted to the registry on 27 Sep 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Senofilcon A/ Lotrafilcon B	21	21
Lotrafilcon B / Senofilcon A	22	21

Primary outcome: Tear Film Kinetics

Time frame: 8 hour post insertion. Mean (Standard Deviation). Unit: Seconds

Measure	Senofilcon A n = 41	Lotrafilcon B n = 41
Value	5.590 (4.2705)	6.941 (6.1257)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation (per-protocol). One subjects was excluded from the analysis population due to a major protocol deviation.

Primary outcome: Time Controlled Visual Acuity

Time frame: 8 hours post insertion. Mean (Standard Deviation). Unit: LogMAR

Measure	Senofilcon A n = 41	Lotrafilcon B n = 41
Distance	-0.06 (0.092)	-0.07 (0.075)
Intermediate	0.07 (0.077)	0.06 (0.074)

Population analysed: The analysis population consists of subjects that completed all study visits without a major protocol deviation. The analysis was conducted for each lens at both near (40cm) and far distance (4m).

Adverse events

Time frame: Throughout the duration of the study. Approximately 1 month per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Senofilcon A	0 of 43 (0%)	3 of 43 (7%)	Not reported
Lotrafilcon B	0 of 43 (0%)	4 of 43 (9.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Eye Dryness

Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingObservational study
Pain Phenotyping of Rheumatic Diseases - An Observational Study
Rheumatic Diseases, Lupus Erythematosus, Systemic
RecruitingPhase 1/2
Autologous Transplantation of Induced Pluripotent Stem Cell-Derived Retinal Pigment Epithelium for Geographic Atrophy Associated With Age-Related Macular Degeneration
Dry Age-Related Macular Degeneration, Geographic Atrophy
RecruitingObservational study
The Pathogenesis and Natural History of Sjogren's Disease
Sjogren's Syndrome, Salivary Gland

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing senofilcon A and lotrafilcon B in people with Eye Dryness, run by Johnson & Johnson Vision Care, Inc. at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Sep 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Tear Film Kinetics (time frame: 8 hour post insertion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02212301.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2016.