Ocular PhysiologyNCT05530889
Evaluating Quality of Life Benefits of ACUVUE® Theravision® With Ketotifen in Subjects With Ocular Allergies
A study testing TEST Lens in people with Ocular Physiology, run by Johnson & Johnson Vision Care, Inc..
Trial summary
This will be a prospective, randomized, bilateral eye, crossover, non-masked single site pilot study to compare the severity of symptoms of itching between test and control lens after two weeks of wear. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ocular Physiology
- What is being tested?
- TEST Lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2024to 13 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 participants must satisfy all of the following criteria to be enrolled in the study
- Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be at least 18 years of age at the time of screening.
- By self-report, habitually wear soft, daily, spherical contact lenses in both eyes. Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the last 4 weeks.
- Willing to wear study lenses for at least 5 days per week and 6 hours per day.
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- Possess a wearable pair of spectacles that provide correction for distance vision and agree to wear them on the day of the dispense visit (V2).
- Must agree and be willing to not wear their habitual contact lenses on the day of the lens dispense visit (V2)
- Report symptoms of allergy, including itchy eyes.
- Oral medication and/or eye drops to treat allergy symptoms must have been used for at least 2 weeks, for a minimum of 3 times per week, prior to the screening visit.
- Must be willing to cease use of habitual eye drops to relieve allergy symptoms during the ACUVUE® Theravision® with Ketotifen wear period.
- The spherical equivalent of the participant's vertex corrected distance refraction must be between -0.50 and -7.00 DS (inclusive) in each eye.
- The magnitude of the cylindrical component of the participant's vertex-corrected distance refraction must be no more than -1.00 DC (inclusive) in each eye.
- Must achieve best corrected visual acuity (BCVA) of at least +0.20 logMAR in each eye.
Who cannot join
- Potential participants who meet any of the following criteria will be excluded from participating in the study:
- Be currently using any ocular medications, with the exception of eye drops for the treatment of their allergy symptoms.
- Take any medications for which a stable regimen has not been achieved (i.e. have started a new medication or changed dosage of an existing medication within the last four weeks).
- Have a known hypersensitivity or allergic reaction to ketotifen or sodium fluorescein.
- Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
- Be an employee (e.g., Investigator, Coordinator, Technician) of the Centre for Ocular Research \& Education listed on the study Delegation Log or immediate family member of these employees (including partner, child, parent, grandparent, grandchild or sibling of the employee or their spouse).
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- Have had or have planned (within the study period) any ocular or intraocular surgery (e.g., radial keratotomy, PRK, LASIK, iridotomy, retinal laser photocoagulation, etc.).
- Be currently using bifocal, multifocal or monovision contact lenses, or wear lenses in an extended wear modality (sleep in lenses)
- Have any active ocular infection of any type.
- Have clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
- Have clinically significant (grade 3 or 4) papillary conjunctivitis or bulbar injection which might interfere with contact lens wear and that are unlikely to be related to their ocular allergy (at the investigator's discretion).
- Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.
About this study
This will be a prospective, randomized, bilateral eye, crossover, non-masked single site pilot study to compare the severity of symptoms of itching between test and control lens after two weeks of wear.
- Conditions
- Ocular Physiology
- Being tested
- TEST Lens, CONTROL Lens
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TEST LensDevice
ACUVUE® Theravision® with Ketotifen
CONTROL LensDevice
1-DAY ACUVUE® MOIST.
| Study group | Role | What they receive |
|---|---|---|
| TEST/CONTROL | Experimental | Eligible subjects who suffer from ocular allergies and who wear contact lenses will be randomized into the wear sequence (TEST/CONTROL) to wear the study lenses during each dispensing period (12-16 days). Receives: Device: TEST Lens; Device: CONTROL Lens |
| CONTROL/TEST | Experimental | Eligible subjects who suffer from ocular allergies and who wear contact lenses will be randomized into the wear sequence (CONTROL/TEST) to wear the study lenses during each dispensing period (12-16 days). Receives: Device: TEST Lens; Device: CONTROL Lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective rating of itchiness
The severity of symptoms of itching will be compared (0-4 itching scale with 0.5 steps) between the test and control lens after 2 weeks of wear.
Measured: up to 2-week follow-up
Secondary outcomes (8)
Subjective rating of comfort
Subjective ratings of comfort will be assessed on a 0 to 100 scale after each 2-week wear period.
Measured: up to 2-week follow-up
Subjective rating of dryness
Subjective ratings of dryness will be assessed on a 0 to 100 scale after each 2-week wear period.
Measured: up to 2-week follow-up
Subjective rating of vision
Subjective ratings of vision will be assessed on a 0 to 100 scale after each 2-week wear period.
Measured: up to 2-week follow-up
Subjective rating of handling
Subjective ratings of handling will be assessed on a 0 to 100 scale after each 2-week wear period.
Measured: up to 2-week follow-up
CLDEQ-8 Questionnaire
CLDEQ-8 is a dry eye questionnaire that asks the participant to reflect and rate their symptoms of eye discomfort and dryness over the past two weeks. A higher composite score indicates more severe dryness and the range is 0-37.
Measured: up to 2-week follow-up
Comfortable and total CL wear time
Total wearing time and total comfortable wearing time will be recorded after each 2-week wear period.
Measured: up to 2-week follow-up
Subject Preference Questionnaire
The subject will select their preferred study lens, test lens or control lens.
Measured: at the 2-week follow-up
MiniRQLQ Questionnaire
The MiniRQLQ is a validated questionnaire that focuses on the impact of allergies on quality of life (QoL). It includes 14 questionnaire items in five sections (activities, practical problems, nasal symptoms, ocular symptoms, general symptoms) that address how allergies impacted QoL during the previous week, by asking the user to rate how troubling each item in the questionnaire was perceived.
Measured: up to 2-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start15 Jan 2024 (estimated)
- Primary completion13 May 2024 (estimated)
- Study completion13 May 2024 (estimated)
Why it stopped: Due to changes in business priorities, CR-6494 has been withdrawn.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular PhysiologyStudies 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Vision Care, Inc. Clinical Trial, Study director, Johnson & Johnson Vision Care, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530889
- Sponsor's protocol ID
- CR-6494
- Status last verified
- Jan 2024
- First submitted
- 29 Aug 2022
- Last updated
- 1 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Quality of Life Benefits of ACUVUE® Theravision® With Ketotifen in Subjects With Ocular Allergies
- ClinicalTrials.gov ID
- NCT05530889
- Acronym / sponsor ID
- CR-6494
- Conditions
- Ocular Physiology
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to changes in business priorities, CR-6494 has been withdrawn.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johnson & Johnson Vision Care, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Jan 2024 (estimated)
- Primary completion
- 13 May 2024 (estimated)
- Study completion
- 13 May 2024 (estimated)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective, randomized, bilateral eye, crossover, non-masked single site pilot study to compare the severity of symptoms of itching between test and control lens after two weeks of wear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TEST/CONTROL | Experimental | Device: TEST Lens, Device: CONTROL LensEligible subjects who suffer from ocular allergies and who wear contact lenses will be randomized into the wear sequence (TEST/CONTROL) to wear the study lenses during each dispensing period (12-16 days). |
| CONTROL/TEST | Experimental | Device: TEST Lens, Device: CONTROL LensEligible subjects who suffer from ocular allergies and who wear contact lenses will be randomized into the wear sequence (CONTROL/TEST) to wear the study lenses during each dispensing period (12-16 days). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Potential participants must satisfy all of the following criteria to be enrolled in the study
- Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
- Appear able and willing to adhere to the instructions set forth in this clinical protocol.
- Be at least 18 years of age at the time of screening.
- By self-report, habitually wear soft, daily, spherical contact lenses in both eyes. Habitual wear is defined as a minimum of 6 hours of wear per day, for a minimum of 5 days per week during the last 4 weeks.
Key exclusion criteria (12 listed)
- Potential participants who meet any of the following criteria will be excluded from participating in the study:
- Be currently using any ocular medications, with the exception of eye drops for the treatment of their allergy symptoms.
- Take any medications for which a stable regimen has not been achieved (i.e. have started a new medication or changed dosage of an existing medication within the last four weeks).
- Have a known hypersensitivity or allergic reaction to ketotifen or sodium fluorescein.
- Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
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 |
|---|---|---|
| TEST LensACUVUE® Theravision® with Ketotifen | Device | CONTROL/TEST, TEST/CONTROL |
| CONTROL Lens1-DAY ACUVUE® MOIST. | Device | CONTROL/TEST, TEST/CONTROL |
Primary outcome
Subjective rating of itchiness
Time frame: up to 2-week follow-up
The severity of symptoms of itching will be compared (0-4 itching scale with 0.5 steps) between the test and control lens after 2 weeks of wear.
8 secondary outcomes
Subjective rating of comfort
Time frame: up to 2-week follow-up
Subjective rating of dryness
Time frame: up to 2-week follow-up
Subjective rating of vision
Time frame: up to 2-week follow-up
Subjective rating of handling
Time frame: up to 2-week follow-up
CLDEQ-8 Questionnaire
Time frame: up to 2-week follow-up
Comfortable and total CL wear time
Time frame: up to 2-week follow-up
Subject Preference Questionnaire
Time frame: at the 2-week follow-up
MiniRQLQ Questionnaire
Time frame: up to 2-week follow-up
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Yes. Johnson \& Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu
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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.
Johnson & Johnson Vision Care, Inc. Clinical Trial study director
Johnson & Johnson Vision Care, Inc.
Questions about this trial
What is this clinical trial studying?
A study testing TEST Lens in people with Ocular Physiology, run by Johnson & Johnson Vision Care, 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 14 inclusion and 12 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: withdrawn, as of the sponsor's last update on 1 Feb 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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 rating of itchiness (time frame: up to 2-week follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2024.