Visual performance and satisfaction with multifocal contact lenses

Not Applicable

Completed

• Conditions: Presbyopia; Eye Diseases

• Registration Number: ISRCTN96782461
• Lead Sponsor: CooperVision Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-08-05
• Study Completion: 2016-12-31
• Last Update Posted: 7 October 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

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. Current spectacle or soft contact lens wearer
5. Spectacle refraction:
Distance: Sphere: -6.00D to +4.00D; Astigmatism: 0.00D to -0.75D
Near Addition: Group 1 (Phase 1) - +1.00 to +1.50D; Group 2 (Phase 2) – Subgroup A +1.75 to +2.00D; Subgroup B +2.25 to +2.50D
6. Best corrected visual acuity in each eye of at least 20/25
7. Have normal eyes with the exception of the need for visual correction
8. Be willing and able to adhere to the instructions set in the clinical protocol and maintain the appointment schedule

Exclusion Criteria

To be eligible as a participant, each candidate shall be free of any ocular or medical condition that may affect the results of this study.
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 contact 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
8. Participation in any clinical trial within 30 days of the enrolment visit

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> This is a non-dispensing cross-over study and the primary endpoints will be measured at each of the visits when the test contact lenses are worn. There are a total of 2 to 3 test visits.<br> 1. Measurement of binocular visual acuity at six distances (400, 200, 100, 67, 50, 40cm) at three luminance levels (250cd/m2, 50cd/m2 and 2.5cd/m2). Measurements will be made using letter charts with each of the types of contact lenses being evaluated<br> 2. Visual satisfaction ratings on visual analogue scales and Likert scales with each of the types of contact lenses being evaluated<br>

Secondary Outcome Measures

Name	Time	Method
<br> This is a non-dispensing cross-over study and the primary endpoints will be measured at each of the visits when the test contact lenses are worn. There are a total of 2 to 3 test visits.<br> 1. Measurement of monocular (right and left eyes) visual acuity at six distances (400, 200, 100, 67, 50, 40cm) at three luminance levels (250cd/m2, 50cd/m2 and 2.5cd/m2). Measurements will be made using letter charts with each of the types of contact lenses being evaluated.<br>