Kelvin Grove, Queensland, 4059, Australia
NCT Number: NCT02349438
Assessment of Contact Lens Wettability Using Wavefront Aberrometry
This study will test the feasibility that differences in contact lens wettability can be measured with a wavefront sensor.
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Notify MeKey information
Conditions
Age range
18 year–40 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Senofilcon A
DeviceA soft spherical contact lens
lotrafilcon B
DevicePrimary outcomes
-
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Natural Blinking
Time frame: 2 hours post insertion
Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with natural blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
-
Higher Order Root Mean Square (HO RMS) - Near Target in Downgaze With Controlled Blink
Time frame: 2 hours post insertion
Wavefront metric measured by COAS wavefront sensor while subject fixates a near digital device in a down-gaze position with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
-
Higher Order Root Mean Square (HO RMS) - Distance Target in Primary Gaze With Controlled Blink
Time frame: 2 hours post insertion
Wavefront metric measured by COAS wavefront sensor while subject fixates a distant target in primary gaze with controlled blinking. The average HO RMS was reported for each lens. Lower values indicate better outcome.
Sponsors and collaborators
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Industry
Registry information
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jan 28, 2015
- Registry last updated
- Jun 19, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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