Visual AcuityNCT03733899

An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort

A study testing Local Anesthesia in people with Visual Acuity, 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

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Trial summary

This is a controlled, randomized, subject-masked, 3x3 crossover, non-dispensing, contralateral study. Twenty subjects will be recruited based on their scores (with their habitual lenses) from the Contact Lens Dry Eye Questionnaire-8 and examined on four occasions. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Visual Acuity
What is being tested?: Local Anesthesia
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 22 participants
Where: 1 siteUnited Kingdom
Study dates: 7 Nov 2018to 7 Feb 2019
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 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Potential subjects must satisfy all of the following criteria to be enrolled in the study:
They are of legal age (18 years) and capacity of volunteer.
The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
They must appear able and willing to adhere to the instructions set forth in this clinical protocol.
They have worn the same brand of soft spherical contact lenses for at least the previous three months, by self-report.
They are defined as 'symptomatic' contact lens wearers (CLDEQ-8 score of 20-37) with their habitual contact lenses.

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They are willing to wear their lenses for approximately 14 hours on study days.
They have a wearable pair of spectacles, if applicable.
They agree not to participate in other clinical research for the duration of this study.
They can attain high contrast logMAR visual acuity of 0.20 or better in their habitual contact lenses in each eye.

Who cannot join

Potential subjects who meet any of the following criteria will be excluded from participating in the study:
They have an ocular disorder, which would normally contra-indicate contact lens wear.
They have a systemic disorder, which would normally contra-indicate contact lens wear.
They are using any topical medication such as eye drops or ointment.
They have had cataract or corneal refractive surgery.
They are pregnant or breast-feeding by self-report.

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They have any infectious disease (e.g. hepatitis) or any immunosuppressive disease (e.g. HIV), by self-report.
They have any known hypersensitivity or allergic reaction to any of the known ingredients in the anesthetic.
They have a history of severe allergic reaction or anaphylaxis.
They have a history of cardiac disease or hyperthyroidism.
They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
They are an employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
They have grade 3 or greater of any of the following ocular surface signs which would contraindicate contact lens wear: corneal edema, corneal vascularisation, corneal staining, tarsal conjunctival changes or any other abnormality which would normally contraindicate contact lens wear.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

The University of Manchester
Manchester, M13 9PL

Other trials in United Kingdom

About this study

Conditions: Visual Acuity
Being tested: Local Anesthesia, Placebo

What participants receive

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

Local AnesthesiaDiagnostic test
Minims Proxymetacaine hydrochloride Eye Drops
PlaceboDiagnostic test
Sodium Chloride Solution

Study groups in NCT03733899
Study group	Role	What they receive
Upper lid margin/Lower lid margin/Cornea	Experimental	Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences of an ocular surface region. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye). Receives: Diagnostic Test: Local Anesthesia; Diagnostic Test: Placebo
Lower lid margin/Cornea/ Upper lid margin	Experimental	Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye). Receives: Diagnostic Test: Local Anesthesia; Diagnostic Test: Placebo
Cornea/Upper lid margin/Lower lid margin	Experimental	Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye). Receives: Diagnostic Test: Local Anesthesia; Diagnostic Test: Placebo
Cornea/Lower lid margin/Upper lid margin	Experimental	Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye). Receives: Diagnostic Test: Local Anesthesia; Diagnostic Test: Placebo
Upper lid margin/Cornea/Lower lid margin	Experimental	Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye). Receives: Diagnostic Test: Local Anesthesia; Diagnostic Test: Placebo
Lower lid margin/Upper lid margin/Cornea	Experimental	Subjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye). Receives: Diagnostic Test: Local Anesthesia; Diagnostic Test: Placebo

What is being measured

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

Subjective Comfort Scores
Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Measured: 5 and 10 Minutes post-treament
Change in Subjective Comfort Scores From Pre-treatment to Post-treatment
Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable. Subjects wore their habitual contacts during the pre-treatment assessment.
Measured: 14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament
Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic
Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Measured: Immediately after lens-insertion, 5 and 10 minutes post-treatment

Secondary outcomes (3)

Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic
Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Measured: 5 and 10 minutes post treatment
Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions
Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Measured: 14 hours upon lens-insertion (pre-treatment), 5- and 10- minutes post-treatment
Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea
Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Measured: Immediately before lens-insertion (pre-insertion), 30 seconds after lens removal

Timeline

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

7 Nov 20187 Feb 2019

First posted7 Nov 2018
Study start7 Nov 2018
Primary completion7 Feb 2019
Study completion7 Feb 2019

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 Visual AcuityStudies 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: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03733899
Sponsor's protocol ID: CR-6292
Status last verified: Apr 2025
First submitted: 6 Nov 2018
Last updated: 25 Apr 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: 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

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All Visual Acuity trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Investigation of the Impact of Localized Topical Anesthesia of the Ocular Surface on End-of-day Contact Lens Discomfort
ClinicalTrials.gov ID: NCT03733899
Acronym / sponsor ID: CR-6292
Conditions: Visual Acuity
Study type: Interventional
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
Study start: 7 Nov 2018 (actual)
Primary completion: 7 Feb 2019 (actual)
Study completion: 7 Feb 2019 (actual)
First posted: 7 Nov 2018 (actual)
Results: Posted 6 Feb 2020

Clinical summary

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (participant)
Number of arms: 6

Arm	Type	Receives
Upper lid margin/Lower lid margin/Cornea	Experimental	Diagnostic Test: Local Anesthesia, Diagnostic Test: PlaceboSubjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences of an ocular surface region. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).
Lower lid margin/Cornea/ Upper lid margin	Experimental	Diagnostic Test: Local Anesthesia, Diagnostic Test: PlaceboSubjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).
Cornea/Upper lid margin/Lower lid margin	Experimental	Diagnostic Test: Local Anesthesia, Diagnostic Test: PlaceboSubjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).
Cornea/Lower lid margin/Upper lid margin	Experimental	Diagnostic Test: Local Anesthesia, Diagnostic Test: PlaceboSubjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).
Upper lid margin/Cornea/Lower lid margin	Experimental	Diagnostic Test: Local Anesthesia, Diagnostic Test: PlaceboSubjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).
Lower lid margin/Upper lid margin/Cornea	Experimental	Diagnostic Test: Local Anesthesia, Diagnostic Test: PlaceboSubjects that are at least 18 years of age wearing their habitual lenses will be randomized into one of six unique sequences. For each region within a sequence, the two treatments will be randomly assigned to the left and right eye (anesthesia left eye/placebo right eye OR placebo left eye/anesthesia left eye).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Potential subjects must satisfy all of the following criteria to be enrolled in the study:

Key exclusion criteria (14 listed)

Potential subjects who meet any of the following criteria will be excluded from participating in the study:

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
Local AnesthesiaMinims Proxymetacaine hydrochloride Eye Drops	Diagnostic test	Cornea/Lower lid margin/Upper lid margin, Cornea/Upper lid margin/Lower lid margin, Lower lid margin/Cornea/ Upper lid margin, Lower lid margin/Upper lid margin/Cornea, Upper lid margin/Cornea/Lower lid margin, Upper lid margin/Lower lid margin/Cornea
PlaceboSodium Chloride Solution	Diagnostic test	Cornea/Lower lid margin/Upper lid margin, Cornea/Upper lid margin/Lower lid margin, Lower lid margin/Cornea/ Upper lid margin, Lower lid margin/Upper lid margin/Cornea, Upper lid margin/Cornea/Lower lid margin, Upper lid margin/Lower lid margin/Cornea

Primary outcome

Subjective Comfort Scores
Time frame: 5 and 10 Minutes post-treament
Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.
Change in Subjective Comfort Scores From Pre-treatment to Post-treatment
Time frame: 14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament
Subjects were asked to rate how comfortable each eye was overall using a visual analog scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable. Subjects wore their habitual contacts during the pre-treatment assessment.
Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic
Time frame: Immediately after lens-insertion, 5 and 10 minutes post-treatment
Subjects were asked to rate how comfortable each eye was overall on the scale of 0 to 100 where 0=worse comfort imaginable and 100=best comfort imaginable.

3 secondary outcomes

Change in Subjective Comfort Between Ocular Regions at Posttreatment Within Anesthetic
Time frame: 5 and 10 minutes post treatment
Change in Subjective Comfort From Pre-treatment to Post-Treatment Between Ocular Regions
Time frame: 14 hours upon lens-insertion (pre-treatment), 5- and 10- minutes post-treatment
Subjective Comfort Difference Between Post-removal and Preinsertion Within Anesthetic and Cornea
Time frame: Immediately before lens-insertion (pre-insertion), 30 seconds after lens removal

Results and safety

Results posted to the registry on 6 Feb 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Lower Lid Margin/Upper Lid Margin/Cornea	3	3
Lower Lid Margin/Cornea/Upper Lid Margin	3	3
Upper Lid Margin/Lower Lid Margin/Cornea	3	3
Upper Lid Margin/Cornea/Lower Lid Margin	4	4
Cornea/Lower Lid Margin/Upper Lid Margin	4	4
Cornea/Upper Lid Margin/Lower Lid Margin	3	2

Primary outcome: Subjective Comfort Scores

Time frame: 5 and 10 Minutes post-treament. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Test (Anesthetic)- Cornea n = 12	Placebo- Cornea n = 15	Test (Anesthetic) - Upper Lid Margin n = 18	Placebo- Upper Lid Margin n = 17	Test (Anesthetic)- Lower Lid Margin n = 19	Placebo- Lower Lid Margin n = 18
5- Mintues Post Treatment	79.25 (8.925)	70.93 (20.838)	61.00 (20.807)	61.94 (16.783)	64.00 (20.915)	61.06 (21.292)
10- Mintues Post Treatment	18.50 (10.265)	72.33 (20.430)	65.11 (21.766)	64.00 (19.239)	70.79 (16.511)	63.17 (20.667)

Test (Anesthetic)- Cornea vs Placebo- Cornea: Least-Square Mean Difference: 2.6 (95% CI -7.3 to 12.4), Linear Mixed Model
Test (Anesthetic)- Cornea vs Placebo- Cornea: Least-square Mean Difference: 0.9 (95% CI -9.6 to 11.5), Linear Mixed Model
Test (Anesthetic) - Upper Lid Margin vs Placebo- Upper Lid Margin: Least-Square Mean Difference: 0.8 (95% CI -8.2 to 9.8), Linear Mixed Model

Population analysed: All randomized subjects regardless of actual treatment and subsequent withdrawl from the study or deviation from protocol.

Primary outcome: Change in Subjective Comfort Scores From Pre-treatment to Post-treatment

Time frame: 14-Hours upon Lens-Insertion (pre-treatment), and 10 Minutes post-treament. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Test (Anesthetic)- Cornea n = 12	Placebo- Cornea n = 15	Test (Anesthetic) - Upper Lid Margin n = 18	Placebo- Upper Lid Margin n = 17	Test (Anesthetic)- Lower Lid Margin n = 19	Placebo- Lower Lid Margin n = 18
5- Mintues Post Treatment	79.25 (8.925)	70.93 (20.838)	61.00 (20.807)	61.94 (16.783)	64.00 (20.915)	61.06 (21.292)
10- Mintues Post Treatment	18.50 (10.265)	72.33 (20.430)	65.11 (21.766)	64.00 (19.239)	70.79 (16.511)	63.17 (20.667)
Pre-treatment	62.35 (23.238)	60.16 (24.862)	56.67 (24.867)	58.35 (24.746)	60.11 (24.669)	57.94 (21.939)

Test (Anesthetic)- Cornea vs Placebo- Cornea: Least-Square Mean Difference: 2.1 (95% CI -10.3 to 14.4), Linear Mixed Model
Test (Anesthetic)- Cornea vs Placebo- Cornea: Least-square Mean Difference: 0.4 (95% CI -12.1 to 12.9), Linear Mixed Model
Test (Anesthetic) - Upper Lid Margin vs Placebo- Upper Lid Margin: Least-Square Mean Difference: 0.3 (95% CI -11.4 to 12.1), Linear Mixed Model

Population analysed: All randomized subjects regardless of actual treatment and subsequent withdrawl from the study or deviation from protocol.

Primary outcome: Subjective Comfort Score Difference Between Post-treatment and Post-insertion Within Anesthetic

Time frame: Immediately after lens-insertion, 5 and 10 minutes post-treatment. Mean (Standard Deviation). Unit: Units on a Scale

Measure	Test (Anesthetic)- Corneal n = 12	Test (Anesthetic) - Upper Lid Margin n = 18	Test (Anesthetic)- Lower Lid Margin n = 19
Immediate Post Lens Insertion	78.06 (17.243)	73.33 (22.646)	80.37 (14.064)
5-Minutes Post Treatment	79.25 (8.925)	61.00 (20.807)	64.00 (20.915)
10 Minutes Post Treatment	78.50 (10.265)	65.11 (21.766)	70.79 (16.511)

Test (Anesthetic)- Corneal: Mean Difference (Final Values): -4.0 (95% CI -13.2 to 5.1), Mixed Models Analysis
Test (Anesthetic)- Corneal: Mean Difference (Final Values): -4.3 (95% CI -13.9 to 5.3), Mixed Models Analysis
Test (Anesthetic)- Lower Lid Margin: Mean Difference (Final Values): -16.4 (95% CI -24.4 to -8.3), Mixed Models Analysis

Population analysed: All randomized subjects regardless of actual treatment and subsequent withdrawal from study or deviation from protocol.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Throughout the entire duration of the study. Up to 6-weeks per subject.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	0 of 20 (0%)	0 of 20 (0%)	0 of 20
Test (Anesthetic)	0 of 20 (0%)	0 of 20 (0%)	0 of 20

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

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 Local Anesthesia in people with Visual Acuity, 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 14 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 25 Apr 2025. 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 6 Feb 2020). 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?

Subjective Comfort Scores (time frame: 5 and 10 Minutes post-treament). The study lists 3 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 NCT03733899.

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 25 Apr 2025.