Clinical trial NCT05530889: Evaluating Quality of Life Benefits of ACUVUE® Theravision® With Ketotifen in Subjects With Ocular Allergies
Official title: Evaluating Quality of Life Benefits of ACUVUE® Theravision® With Ketotifen in Subjects With Ocular Allergies
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ocular Physiology
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2022-09-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

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

1. Read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. Appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. Be at least 18 years of age at the time of screening.
4. 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.
5. Willing to wear study lenses for at least 5 days per week and 6 hours per day.
6. 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).
7. Must agree and be willing to not wear their habitual contact lenses on the day of the lens dispense visit (V2)
8. Report symptoms of allergy, including itchy eyes.
9. 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.
10. Must be willing to cease use of habitual eye drops to relieve allergy symptoms during the ACUVUE® Theravision® with Ketotifen wear period.
11. The spherical equivalent of the participant's vertex corrected distance refraction must be between -0.50 and -7.00 DS (inclusive) in each eye.
12. 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.
13. Must achieve best corrected visual acuity (BCVA) of at least +0.20 logMAR in each eye.

Exclusion Criteria:

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

1. Be currently using any ocular medications, with the exception of eye drops for the treatment of their allergy symptoms.
2. 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).
3. Have a known hypersensitivity or allergic reaction to ketotifen or sodium fluorescein.
4. Have participated in a contact lens or lens care product clinical trial within 14 days prior to study enrollment.
5. 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).
6. 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.).
7. Be currently using bifocal, multifocal or monovision contact lenses, or wear lenses in an extended wear modality (sleep in lenses)
8. Have any active ocular infection of any type.
9. 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.
10. 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).
11. Have fluctuations in vision due to clinically significant dry eye or other ocular conditions.

Primary outcomes:
measure: Subjective rating of itchiness
timeFrame: up to 2-week follow-up
Secondary outcomes:
measure: Subjective rating of comfort
timeFrame: up to 2-week follow-up
measure: Subjective rating of dryness
timeFrame: up to 2-week follow-up
measure: Subjective rating of vision
timeFrame: up to 2-week follow-up
measure: Subjective rating of handling
timeFrame: up to 2-week follow-up
measure: CLDEQ-8 Questionnaire
timeFrame: up to 2-week follow-up
measure: Comfortable and total CL wear time
timeFrame: up to 2-week follow-up
measure: Subject Preference Questionnaire
timeFrame: at the 2-week follow-up
measure: MiniRQLQ Questionnaire
timeFrame: up to 2-week follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Vision Care, Inc.
name: Johnson & Johnson Vision Care, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: