Condition category
Eye Diseases
Date applied
29/06/2016
Date assigned
19/07/2016
Last edited
15/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Presbyopia is a chronic, age-related gradual loss of the ability of the eye to change focus in order to be able to see objects at near distances. Current optical options for patients with presbyopia include reading glasses, bifocal and multifocal glasses and contact lenses, and in some cases refractive surgery is performed. Contact lens vision correction is achieved using monovision contact lenses (where one eye is fully corrected for the distance and the other eye is corrected for the near vision) or multifocal contact lenses (both eyes have distance and near vision correction). The aim of this study is to evaluate a new type of near vision correction with commercially available contact lenses.

Who can participate?
Patients at least 50 years of age who have presbyopia

What does the study involve?
Each participant wears two different types of contact lenses for about 1 to 1.5 hours each in a randomly allocated order. Visual performance is measured by detecting changes in eye position related to near vision tasks.

What are the possible benefits and risks of participating?
There is no direct medical benefit to you, but the information obtained in this study may be helpful to others who wear contact lenses in the future. The risks of the study lens are similar to those of wearing any type of soft contact lens. These include eye irritation, pain, redness and swelling; a painful scrape or scratch on the surface of the clear part of the eye; blurred vision and sensation of dry eyes. Participants may get an infection from the contact lens or have an allergy to lens components. Comfort of the lenses may not be fully optimized for participants and they may experience discomfort. These risks may be mild to severe and may go away on their own or require treatment. Additionally, there may be side effects that are not known at this time. Participants are advised that if they develop any adverse symptoms (pain, swelling, redness, blurred vision, sensation or dry eyes) within 24 hours after wearing the study lenses, they should contact the Investigator immediately.

Where is the study run from?
Ocular Technology Group - International (UK)

When is the study starting and how long is it expected to run for?
December 2015 to June 2016

Who is funding the study?
Verily Life Sciences, LLC (USA)

Who is the main contact?
Trisha Patel

Trial website

Contact information

Type

Public

Primary contact

Ms Trisha Patel

ORCID ID

Contact details

66 Buckingham Gate
London
SW1E 6AU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2015-AL-001

Study information

Scientific title

Investigation of visual acuity with near-intermediate monovision contact lens correction

Acronym

Study hypothesis

To demonstrate superiority of high contrast near visual acuity (HC-NVA) and low contrast intermediate visual acuity (LC-IVA) with a near-intermediate commercially-available monovision contact lens correction as compared to a commercially-available multifocal contact lens correction.

Ethics approval

London - Queen Square Research Ethics Committee, 02/02/2016, REC ref: 16/LO/0234

Study design

Prospective crossover single-center feasibility study

Primary study design

Interventional

Secondary study design

Randomised cross over trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Presbyopia

Intervention

Prospective crossover single-center feasibility study of two presbyopia-correcting contact lens systems. Up to 130 subjects will be randomized. Each subject will wear one Test Lens System (AIROPTIX AQUA) and one Control Lens System (AIROPTIX AQUA - Multifocal) in a randomized fashion for approximately 1 to 1.5 hours each. A randomization table will be generated assigning each subject into a specific order of lens wear. Subjects will be randomly assigned in a 1:1 fashion.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. High-contrast near visual acuity (HC-NVA)
2. Low-contrast intermediate visual acuity (LC-IVA)

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

1. Low-contrast near visual acuity (LC-NVA) and stereopsis
2. The safety endpoints are biomicroscopy findings and adverse events

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.

Overall trial start date

01/12/2015

Overall trial end date

30/06/2016

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Up to 130

Participant 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

Recruitment start date

22/02/2016

Recruitment end date

30/06/2016

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Ocular Technology Group - International
66 Buckingham Gate
London
SW1V 2RX
United Kingdom

Sponsor information

Organisation

Verily Life Sciences LLC (USA)

Sponsor details

1600 Amphitheatre Parkway
Mountain View
94043
United States of America

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Verily Life Sciences, LLC (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Peer-reviewed scientific journals, internal report and conference presentation

Intention to publish date

30/07/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes