London, SW1E6AU, United Kingdom
NCT Number: NCT02345720
Effects of Multifocal Contact Lens on Ocular Tissue
The purpose of this study is to evaluate the etafilcon - PVP (multi-focal)
Looking for future studies?
Notify MeKey information
Conditions
Age range
40 year–70 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
- 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 be between 40 and 70 years of age.
- The subject's vertex corrected spherical equivalent distance refraction must be in the range of 1.00 too -5.75 in each eye.
- The subject must identify themselves as Asian by self-report and have eyes and eyelids with an automatically Asian appearance.
- The subject's refractive cylinder must be less than or equal to -0.75D in each eye.
- The subject's ADD power must be in the range of +0.75 D to +2.5 D in each eye.
- The subject must have best corrected visual acuity of 20/20-3 or better in each eye.
- Subjects own a wearable pair of spectacles, if required for their distance vision.
- The subject must be an adapted soft contact lens wearer in both eyes (i.e. worn lenses a minimum of 5 days per week for at least 8 hours per day, for one month or more duration).
- The subject must already be wearing a presbyopic contact lens correction (e.g. reading spectacles over contact lenses, multifocal or monovision contact lenses, etc.) or if not respond positively to at least one symptom on the "Presbyopic Symptoms Questionnaire".
Exclusion criteria
- Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued)
- Any ocular or systemic allergies that contraindicate contact lens wear.
- Any ocular or systemic disease, autoimmune disease, or use of medication, that will contraindicate contact lens wear.
- Any ocular abnormality that may interfere with contact lens wear.
- Use of any ocular medications, with the exception of rewetting drops.
- Any previous intraocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.).
- Any grade 3 or greater slit lamp findings (e.g. edema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) which may contraindicate contact lens wear.
- History of herpetic keratitis.
- Any ocular infection or inflammation.
- Any corneal distortion or irregular cornea.
- History of binocular vision abnormality or strabismus.
- Any infectious disease (e.g. hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g. HIV).
- History of diabetes.
- Habitual wearer of etafilcon-A contact lens material.
- Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
Treatment and study plan
etafilcon - PVP (multi-focal)
DeviceThe investigational contact lens must be worn at least six hours daily.
Primary outcomes
-
Upper Eye Lid Margin Staining
Time frame: 30 days Post wear
Upper Eye Lid Margin Staining is assessed via Ocular Photography using proprietary algorithm. The average grade across upper eye lid margin was reported in mm^2.
-
Limbal Staining
Time frame: 30 Days Post Wear
Measured via Ocular Photography using proprietary algorithm. The limbal conjunctival lissamine green staining average surface area in % of the overall limbal area was reported.
-
Corneal Staining
Time frame: 30 Days Post Wear
The corneal fluorescein staining average surface area in % of the upper corneal quadrant was reported.
Sponsors and collaborators
Lead sponsor
Johnson & Johnson Vision Care, Inc.
Industry
Registry information
Official study title
Effects on Ocular Tissues of Vistakon® Investigational Multifocal Contact Lenses - Asian Population Study
Important dates
- Study start
- 2014
- Primary completion
- 2015
- Study completion
- 2015
- First posted
- Jan 26, 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.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Evaluation of Approved Contact Lenses
NCT07174596
Visual Acuity
Roswell, Georgia, United States
View Trial DetailsPilot Dispensing Study of Two Marketed Daily Disposable Multifocal Contact Lenses
NCT07076160
Eye Diseases, Presbyopia
Jacksonville, Florida, United States
View Trial DetailsClinical Evaluation of Two Cosmetic Contact Lenses
NCT06864858
Visual Acuity
Maitland, Florida, United States
View Trial DetailsEvaluation of Effect of Scatter on Visual Performance
NCT07443215
Visual Acuity
Jacksonville, Florida, United States
View Trial Details