ISRCTN12120712CompletedNot Applicable
Investigation of visual acuity with near-intermediate monovision contact lens correction
Verily Life Sciences LLC (USA)0 sites130 target enrollmentStarted: July 19, 2016Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 130
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Healthy and competent, as determined by the Investigator
- •2. At least 50 years of age
- •3. Able to read and speak English
- •4. Able and willing to sign written Informed Consent Form
- •5. Must be a current or former contact lens wearer
- •6. Must have at least 20/25 distance and near vision in each eye best corrected
- •7. Must use a presbyopic reading correction of at least +2.25 diopters
- •8. Must have < or = 1.00D astigmatism
Exclusion Criteria
- •1. Eye injury within 12 weeks immediately prior to enrollment for this study
- •2. Anterior segment infection, inflammation, abnormality or any other anterior segment ocular disease that contraindicates contact lens wear as determined by the Investigator
- •3. Any use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator
- •4. History of herpetic keratitis
- •5. History of refractive surgery or irregular cornea
- •6. History of multifocal or monovision intraocular lens replacement surgery
- •7. > 1.0mm anisocoria
- •8. Slit lamp findings (at baseline) that are more severe than mild findings (greater than grade 2)
- •9. Corneal vascularization greater than 1 mm of penetration
- •10. A clinically significant dry eye determined by the Investigator
- •11. Participation of the subject in a clinical contact lens study (including contact lens or contact lens care product) within the previous 30 days
- •12. The Investigator, family members of the Investigator, family members of the Investigator's staff, or individuals living in the households of the aforementioned persons
- •13. Any additional condition or situation that, in the opinion of the Investigator, makes the subject inappropriate for participation in the study
Investigators
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