A research study to evaluate a novel type of near vision correction with contact lenses

Completed

• Conditions: Presbyopia; Eye Diseases

• Registration Number: ISRCTN12120712
• Lead Sponsor: Verily Life Sciences LLC (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-07-19
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 130

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. High-contrast near visual acuity (HC-NVA)<br>2. Low-contrast intermediate visual acuity (LC-IVA)<br><br>Measured at both the visit when the test contact lens system is being worn and the visit when the control contact lens system is being worn.

Secondary Outcome Measures

Name	Time	Method
1. Low-contrast near visual acuity (LC-NVA) and stereopsis<br>2. The safety endpoints are biomicroscopy findings and adverse events<br><br>Measured at both the visit when the test contact lens system is being worn and the visit when the control contact lens system is being worn.