MyopiaNCT02637804

Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study

A study testing stenfilcon A, narafilcon A and delefilcon A in people with Myopia, run by CooperVision, Inc..

Completed

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

Trial summary

Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical… Read more about this study

Who is it for?: Ages 18 to 40 years
Conditions the study is for: Myopia
What is being tested?: stenfilcon A, narafilcon A and delefilcon A
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 106 participants
Where: No sites listed yet
Study dates: Jan 2016to Aug 2016
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 40 years
All sexes
No healthy volunteers
Adult

Who may be able to join

A person is eligible for inclusion in the study if he/she:
Is over 18 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.
Can achieve a distance visual acuity of 20/30 or better in each eye with the study contact lenses.

Show all 11Show fewer

Has clear corneas and no active ocular disease
Has read, understood and signed the information consent letter.
Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive)
Is willing to comply with the wear schedule.
Is willing to comply with the visit schedule

Who cannot join

A person will be excluded from the study if he/she:
Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses
Has a CL prescription outside the range of the inclusion power range
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
Has contact lens best corrected distance vision worse than 20/25 in either eye

Show all 13Show fewer

Presence of clinically significant (grade 2-4) anterior segment abnormalities
Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear
Slit lamp findings that would contraindicate contact lens wear
Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
Has aphakia, keratoconus or a highly irregular cornea.
Has undergone corneal refractive surgery.
Is participating in any other type of eye related clinical or research study.

About this study

Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A

This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.

Read the detailed description

The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A.

The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.

Study groups:

Group 1: stenfilcon A vs. narafilcon A

Group 2: stenfilcon A vs. delefilcon A

Conditions: Myopia
Being tested: stenfilcon A, narafilcon A, delefilcon A
Medical subject headings: Myopia

What participants receive

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

stenfilcon ADevice
contact lens
narafilcon ADevice
contact lens
delefilcon ADevice
contact lens

Study groups in NCT02637804
Study group	Role	What they receive
stenfilcon A vs narafilcon A (Group 1)	Active comparator	Participants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study. Receives: Device: stenfilcon A; Device: narafilcon A
stenfilcon A vs delefilcon A (Group 2)	Active comparator	Participants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study. Receives: Device: stenfilcon A; Device: delefilcon A

What is being measured

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

Pain and Foreign Body Sensation
Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Measured: 1 week
Itching Sensation on Removal
Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Measured: 1 week
Red Eye Sensation
Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Measured: 1 week
Dryness
Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.
Measured: 1 week
Comfort
Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).
Measured: 1 week
Vision
Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).
Measured: 1 week
Handling
Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.
Measured: 1 week
Lens Preference - Stenfilcon A/Narafilcon A (Group 1)
Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).
Measured: 1 week
Lens Preference - Stenfilcon A/Delefilcon A (Group 2)
Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).
Measured: 1 week

Secondary outcomes (15)

Lens Fit - Horizontal Centration
Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at baseline. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Measured: Baseline
Lens Fit - Horizontal Centration
Lens fit evaluation of horizontal centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Temporal, Little temporal, Centered, Little nasal, Nasal)
Measured: 1 week
Lens Fit - Vertical Centration
Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Upper, Little upper, Centered, Little lower, Lower)
Measured: Baseline
Lens Fit - Vertical Centration
Lens fit evaluation of vertical centration for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Upper, Little upper, Centered, Little lower, Lower)
Measured: 1 week
Lens Fit - Post-blink Movement
Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Tight, Little tight, Optimal, Little loose, Loose)
Measured: Baseline
Lens Fit - Post-blink Movement
Lens fit evaluation of post-blink movement for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Tight, Little tight, Optimal, Little loose, Loose)
Measured: 1 week
Lens Fit Overall
Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at baseline. (Optimum, Good, Acceptable, Not acceptable (cannot wear))
Measured: Baseline
Lens Fit Overall
Lens fit evaluation overall for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Optimum, Good, Acceptable, Not acceptable (cannot wear))
Measured: 1 week
Conjunctival Redness
Conjunctival redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Measured: 1 week
Limbal Redness
Limbal redness for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Measured: 1 week
Corneal Staining
Corneal staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Measured: 1 week
Corneal Neovascularization
Corneal neovascularization for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Measured: 1 week
Conjunctival Staining
Conjunctival staining for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Measured: 1 week
Corneal Oedema
Corneal oedema for for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Measured: 1 week
Papillary Conjunctivitis
Papillary conjunctivitis for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A is assessed at 1 week. (Grading scale 0-4, 0.5 steps 0=Normal, 1=Trace 2=MIld, 3=Moderate 4=Severe)
Measured: 1 week

Timeline

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

Jan 2016Aug 2016

First posted22 Dec 2015 (estimated)
Study startJan 2016
Primary completionMar 2016
Study completionAug 2016

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 MyopiaStudies 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: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: Study participants will be allocated in to 2 parallel groups: Group 1: stenfilcon A and narafilcon A, and Group 2: stenfilcon A and delefilcon A. Each participant will be randomized to wear either lens pair in a bilateral design for 1 week, and then cross over to the alternative pair.
Masking: None (open label)
Enrolment: 106 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02637804
Sponsor's protocol ID: JP-MKTG-201512
Status last verified: Sep 2017
First submitted: 18 Dec 2015
Last updated: 23 Oct 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Undecided

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?

Official record

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All Myopia trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
ClinicalTrials.gov ID: NCT02637804
Acronym / sponsor ID: JP-MKTG-201512
Conditions: Myopia
Study type: Interventional
Recruitment status: Completed
Enrolment: 106 participants (actual)
Lead sponsor: CooperVision, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: Mar 2016 (actual)
Study completion: Aug 2016 (actual)
First posted: 22 Dec 2015 (estimated)
Results: Posted 23 Oct 2017

Clinical summary

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

Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A

Detailed description

The aim of this study is to evaluate the clinical performance of stenfilcon A compared with narafilcon A and delefilcon A.

The study participants will be allocated to two parallel groups (Group 1 and Group 2), 60 subjects each, based on the control lenses, narafilcon A and delefilcon A spherical lenses.

Study groups:

Group 1: stenfilcon A vs. narafilcon A

Group 2: stenfilcon A vs. delefilcon A

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Study participants will be allocated in to 2 parallel groups: Group 1: stenfilcon A and narafilcon A, and Group 2: stenfilcon A and delefilcon A. Each participant will be randomized to wear either lens pair in a bilateral design for 1 week, and then cross over to the alternative pair.

Arm	Type	Receives
stenfilcon A vs narafilcon A (Group 1)	Active comparator	Device: stenfilcon A, Device: narafilcon AParticipants are randomized to wear either stenfilcon A lens pair or narafilcon A lens pair, bilaterally, for 1 week during the cross over study.
stenfilcon A vs delefilcon A (Group 2)	Active comparator	Device: stenfilcon A, Device: delefilcon AParticipants are randomized to wear either stenfilcon A lens pair or delefilcon A lens pair, bilaterally, for 1 week during the cross over study.

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (11 listed)

A person is eligible for inclusion in the study if he/she:
Is over 18 years of age (inclusive)
Has had a self-reported visual exam in the last two years
Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.

Key exclusion criteria (13 listed)

A person will be excluded from the study if he/she:
Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses
Has a CL prescription outside the range of the inclusion power range
Has a spectacle cylinder ≥1.00D of cylinder in either eye.
Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)

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
stenfilcon Acontact lens	Device	stenfilcon A vs delefilcon A (Group 2), stenfilcon A vs narafilcon A (Group 1)
narafilcon Acontact lens	Device	stenfilcon A vs narafilcon A (Group 1)
delefilcon Acontact lens	Device	stenfilcon A vs delefilcon A (Group 2)

Primary outcome

Pain and Foreign Body Sensation
Time frame: 1 week
Subjective ratings of pain and foreign body sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Itching Sensation on Removal
Time frame: 1 week
Subjective ratings of itching sensation on insertion for each lens pair assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Red Eye Sensation
Time frame: 1 week
Subjective ratings of red eye sensation for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. Grade 0-3, 0=No sensation, 1=Slightly: sometimes felt sensation without any trouble in wearing contact lenses, 2=Mild: always felt sensation without any trouble in wearing contact lenses, 3=Heavy: could not wear contact lense due to sensation
Dryness
Time frame: 1 week
Subjective ratings of dryness (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very dry, 10=no dryness at all.
Comfort
Time frame: 1 week
Subjective ratings of comfort (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor comfort, 10=very good comfort).
Vision
Time frame: 1 week
Subjective ratings of vision (right after insertion, right before removal, all day long) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor vision, 10=very good vision).
Handling
Time frame: 1 week
Subjective ratings of handling (lens insertion and lens removal) for stenfilcon A/narafilcon A and stenfilcon A/delefilcon A assessed at 1 week. (Scale 0-10, 0=very poor handling, 10=very good handling.
Lens Preference - Stenfilcon A/Narafilcon A (Group 1)
Time frame: 1 week
Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer narafilcon A, prefer narafilcon A).
Lens Preference - Stenfilcon A/Delefilcon A (Group 2)
Time frame: 1 week
Subjective ratings of lens preference for stenfilcon A/narafilcon A assessed at 1 week. (5 possible ratings: Prefer stenfilcon A, Little Prefer stenfilcon A, No preference, little prefer delefilcon A, prefer delefilcon A).

15 secondary outcomes

Lens Fit - Horizontal Centration
Time frame: Baseline
Lens Fit - Horizontal Centration
Time frame: 1 week
Lens Fit - Vertical Centration
Time frame: Baseline
Lens Fit - Vertical Centration
Time frame: 1 week
Lens Fit - Post-blink Movement
Time frame: Baseline
Lens Fit - Post-blink Movement
Time frame: 1 week
Lens Fit Overall
Time frame: Baseline
Lens Fit Overall
Time frame: 1 week
Conjunctival Redness
Time frame: 1 week
Limbal Redness
Time frame: 1 week
Corneal Staining
Time frame: 1 week
Corneal Neovascularization
Time frame: 1 week
Conjunctival Staining
Time frame: 1 week
Corneal Oedema
Time frame: 1 week
Papillary Conjunctivitis
Time frame: 1 week

Results and safety

Results posted to the registry on 23 Oct 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stenfilcon A, Then Narafilcon A (Group 1)	27	27
Narafilcon A, Then Stenfilcon A (Group 1)	28	28
Stenfilcon A, Then Delefilcon A (Group 2)	25	25
Delefilcon A, Then Stenfilcon A (Group 2)	26	26

Primary outcome: Pain and Foreign Body Sensation

Time frame: 1 week. Number. Unit: eyes

Measure	Stenfilcon A (Group 1) n = 55	Narafilcon A (Group 1) n = 55	Stenfilcon A (Group 2) n = 51	Delefilcon A (Group 2) n = 51
No sensation	89	79	83	87
Slight sensation	21	28	19	13
Mild sensation	0	3	0	2
Heavy sensation	0	0	0	0

Primary outcome: Itching Sensation on Removal

Time frame: 1 week. Number. Unit: Eyes

Measure	Stenfilcon A (Group 1) n = 55	Narafilcon A (Group 1) n = 55	Stenfilcon A (Group 2) n = 51	Delefilcon A (Group 2) n = 51
No sensation	98	102	92	90
Slight sensation	9	8	10	10
Mild sensation	3	0	0	0
Heavy sensation	0	0	0	2

Primary outcome: Red Eye Sensation

Time frame: 1 week. Number. Unit: Eyes

Measure	Stenfilcon A (Group 1) n = 55	Narafilcon A (Group 1) n = 55	Stenfilcon A (Group 2) n = 51	Delefilcon A (Group 2) n = 51
No sensation	98	98	92	87
Slight sensation	12	10	8	15
Mild sensation	0	2	2	0
Heavy sensation	0	0	0	0

Primary outcome: Dryness

Time frame: 1 week. Mean (Standard Deviation). Unit: units on a scale

Measure	Stenfilcon A (Group 1) n = 55	Narafilcon A (Group 1) n = 55	Stenfilcon A (Group 2) n = 51	Delefilcon A (Group 2) n = 51
Right after insertion	9.56 (1.14)	9.40 (1.36)	9.84 (0.50)	9.76 (0.90)
Right before removal	7.37 (2.21)	7.70 (2.10)	7.61 (2.02)	7.71 (2.45)
All day long	8.08 (1.89)	8.36 (1.74)	8.27 (1.66)	8.40 (1.92)

15 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Stenfilcon A (Group 1)	0 of 55 (0%)	0 of 55 (0%)	Not reported
Narafilcon A (Group1)	0 of 55 (0%)	0 of 55 (0%)	Not reported
Stenfilcon A (Group 2)	0 of 51 (0%)	0 of 51 (0%)	Not reported
Delefilcon A (Group 2)	0 of 51 (0%)	0 of 51 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

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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.

Yuji Kodama, MD, PhD principal investigator

Director, Kodama Eye Clinic

Questions about this trial

What is this clinical trial studying?

A study testing stenfilcon A, narafilcon A and delefilcon A in people with Myopia, run by CooperVision, Inc..

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 11 inclusion and 13 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 23 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

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 23 Oct 2017). 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?

Pain and Foreign Body Sensation (time frame: 1 week). The study lists 9 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 NCT02637804.

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 23 Oct 2017.