N/A
N=21
Assessment of Contact Lens Wettability Using Wavefront Aberrometry
Visual Acuity
Bottom Line
View on ClinicalTrials.gov: NCT02349438 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcome: Primary: Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking — 0.159; 0.142 microns
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- senofilcon A (Device); lotrafilcon B (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Johnson & Johnson Vision Care, Inc.
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking |
0.159; 0.142 | — |
| PRIMARY Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink |
0.165; 0.146 | — |
| PRIMARY Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink |
0.125; 0.132 | — |
Summary
This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.
Eligibility Criteria
Inclusion Criteria
- Healthy males or females that are at least 18 to no more than 40 years of age.
- The subject must read, understand, and sign the Statement of Informed Consent and receive a fully executed copy of the form.
- The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
- The subject must possess a wearable pair of spectacles with distance vision correction which provide satisfactory vision.
- 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).
- The subject's vertexed best sphere distance refraction must be between -0.75 and -5.00 D in both eyes.
- Cylinder refraction less than or equal to -0.75 D in both eyes (any axis).
- The subject must have corrected visual acuity of 20/20 or better in each eye.
Exclusion Criteria
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
- Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
- Any systemic disease, autoimmune disease, or use of medication, which may interfere with contact lens wear.
- Any known hypersensitivity or allergic reaction to contact lens solutions or sodium fluorescein dye.
- Any previous ocular or intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
- Current wearers of rigid or hybrid contact lenses.
- Entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, or moderate or above corneal distortion by keratometry.
- Infectious diseases (e.g. hepatitis, tuberculosis) or an immuno-suppressive disease (e.g. HIV).
- History of binocular vision abnormality or strabismus.
- Employee of the investigational clinic (e.g. Investigator, Coordinator, Technician).
- 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.
- Strabismus, suppression or amblyopia.
- Any ocular infection.
Data sourced from ClinicalTrials.gov (NCT02349438). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.