Clinical trial NCT03556579: The Effects of Contact Lenses With Experimental Dye on Visual Function
Official title: The Effects of Contact Lenses With Experimental Dye on Visual Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ametropia
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2018-06-14
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a single-site, two-visit, contralateral, non-dispensing, randomized, controlled and subject-masked study to measure potential benefits of the new UV blocker.


Eligibility criteria: Inclusion Criteria:

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

1. The subject must 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. Between 18 and 65 (inclusive) years of age at the time of screening.
4. Be a current spherical soft silicone hydrogel contact lens wearer in both eyes with a minimum of 6 hours/day and 5 days/week wear time over the last 30 days by self-report.
5. The subject's vertex-corrected spherical equivalent distance refraction must be in the range of -1.00 through -4.50 D in each eye.
6. The subject has a best corrected visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or breastfeeding.
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any autoimmune disease or use of medication, which may interfere with contact lens wear. Habitual medications used by successful soft contact lens wearers are considered acceptable.
4. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, or aphakia.
5. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, PRK, LASIK, etc.).
6. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
7. Multifocal, toric or extended wear contact lens correction.
8. Participation in any contact lens or lens care product clinical trial within 14 days prior to study enrollment.
9. History of binocular vision abnormality or strabismus.
10. Any infectious disease (e.g., hepatitis, tuberculosis) or contagious immunosuppressive diseases (e.g., HIV) by self-report.
11. Employee or immediate family member of an employee of clinical site (e.g., Investigator, Coordinator, Technician).
12. Any ocular infection.
13. Any grade 3 or greater slit lamp findings (e.g., edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the FDA classification scale, any previous history or signs of a contact lens-related corneal inflammatory event (e.g., past peripheral ulcer or round peripheral scar), or any other ocular abnormality that may contraindicate contact lens wear.

Primary outcomes:
measure: Two-Point Light Spread Function
timeFrame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
measure: Halos
timeFrame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
measure: Starburts
timeFrame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 2
Secondary outcomes:
measure: Glare Disability Threshold
timeFrame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
measure: Photostress Recovery Time
timeFrame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
measure: Glare Discomfort
timeFrame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
measure: Heterochromatic Contrast Threshold
timeFrame: Between 5 minutes and 3 hours Post Lens Insertion, at Visit 1
Other outcomes:
Locations:
city: Statesboro
country: United States
facility: Georgia Center for Sight
state: Georgia
Study officials:
References: