Comparative performance and acceptance validation study of CVI new multifocal contact lenses

Not Applicable

Completed

• Conditions: Presbyopia; Eye Diseases

• Registration Number: ISRCTN14364515
• Lead Sponsor: CooperVision (United States)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-01
• Study Start: 2020-02-12
• Last Update Posted: 28 September 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion 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

Exclusion Criteria

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
<br> 1. Subjective overall visual satisfaction measured using the Visual Analog Scale (VAS) at baseline and after 1-week wear with each contact lens type<br> 2. The number of contact lenses needed (count) for fitting per eye prior to dispensing is recorded for each contact lens type<br>

Secondary Outcome Measures

Name	Time	Method
Binocular visual performance (LogMAR visual acuity) measured using letter charts at baseline and after 1-week wear with each contact lens type