Validation of CV multifocal daily disposable contact lenses performance in a multisite study

Not Applicable

Completed

• Conditions: Eye Diseases; Presbyopia, multi-focal contact lenses, vision; Presbyopia

• Registration Number: ISRCTN62897847
• Lead Sponsor: CooperVision Inc. (USA)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-24
• Study Completion: 2019-08-31
• Last Update Posted: 2 November 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

There are no requirements as to participant race, gender or occupation. In order to be enrolled, each participant shall meet the following criteria:
1. At least 40 years old;
2. Have read and understood the Participant Information Sheet
3. Have read, signed and dated the Informed Consent
4. Best corrected visual acuity of at least 20/25 in each eye
5. Have normal eyes with the exception of the need for visual correction
6. Current multifocal contact lens wearer
7. Spectacle refraction:
Distance: Sphere: -6.00D to + 4.00D
Astigmatism: 0.00D to -0.75D
Near Addition: +0.75D to +2.50D in three groups:
Emerging Presbyopes:+0.75D to +1.25D
Established Presbyopes: +1.50D and +1.75D
Advanced presbyopes:+2.00D to +2.50D
8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion Criteria

The following are specific criteria that exclude a candidate from enrolment in this study:
1. Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear
2. Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the investigator
3. Monocular participants (only one eye with functional vision) or participants fit with only one lens
4. Any moderate or severe ocular condition observed during the slit-lamp examination at the enrolment visit
5. History of herpetic keratitis, ocular surgery or irregular cornea
6. Known pregnancy or lactation during the study period
7. Enrolment of the investigator or his/her staff, family members of the investigator, family members of the investigator’s staff, or individuals living in the households of these individuals

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall subjective binocular visual satisfaction score on a 100-point Visual Analog Scale (VAS) at dispensing and after one week wear

Secondary Outcome Measures

Name	Time	Method
<br> 1. Binocular visual acuity measurements using LogMAR charts after 1 week wear<br> 2. The number of contact lenses needed per eye to determine the contact lens to be dispensed at dispensing visit<br>