Clinical trial NCT02349438: Assessment of Contact Lens Wettability Using Wavefront Aberrometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Acuity
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2015-01-28
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.


Eligibility criteria: Inclusion Criteria:

1. Healthy males or females that are at least 18 to no more than 40 years of age.
2. The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
4. The subject must possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision.
5. The subject is a current spherical soft contact lens wearer (defined as a minimum of 6 hours of lens wear per week for a minimum of 1 month prior to the study) or has sufficient prior experience with soft contact lens wear (defined as a minimum of 30 days of lens wear during the last 5 years).
6. The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes.
7. Cylinder refraction less than or equal to -0.75 D in both eyes (any axis).
8. The subject must have corrected visual acuity of 20/20 or better in each eye.

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
4. Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye.
5. Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
6. Current wearers of rigid or hybrid contact lenses.
7. Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
8. Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
9. History of binocular vision abnormality or strabismus.
10. Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician).
11. Clinically significant (grade 3 or 4) corneal edema, pterygium, corneal vascularization, corneal staining, or any other abnormalities of the cornea or conjunctiva which may interfere with the study measurements.
12. Strabismus, suppression or amblyopia.
13. Any ocular infection.

Primary outcomes:
measure: Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking
timeFrame: 2 hours post insertion
measure: Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink
timeFrame: 2 hours post insertion
measure: Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink
timeFrame: 2 hours post insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Kelvin Grove
country: Australia
state: Queensland
Study officials:
References: