Evaluating Quality of Life Benefits of ACUVUE® Theravision® With Ketotifen in Subjects With Ocular Allergies

NCT05530889 | Withdrawn FDA Device

• 1 other identifier: CR-6494
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ocular Physiology

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 2-week follow-up

Secondary Outcomes (8)

• Subjective rating of comfort

  up to 2-week follow-up

• Subjective rating of dryness

  up to 2-week follow-up

• Subjective rating of vision

  up to 2-week follow-up

• Subjective rating of handling

  up to 2-week follow-up

• CLDEQ-8 Questionnaire

  up to 2-week follow-up

Study Arms (2)

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).

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).

Device: TEST Lens; Device: CONTROL Lens

Interventions

TEST Lens DEVICE

ACUVUE® Theravision® with Ketotifen

CONTROL/TEST; TEST/CONTROL

CONTROL Lens DEVICE

1-DAY ACUVUE® MOIST.

CONTROL/TEST; TEST/CONTROL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Officials

• Johnson & Johnson Vision Care, Inc. Clinical Trial

  Johnson & Johnson Vision Care, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 7, 2022
• Study Start: January 15, 2024
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share