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

Comparative performance and acceptance validation study of CooperVision new multifocal contact lenses vs. 1-Day Acuvue® moist contact lenses

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN14364515
Enrollment
60
Registered
2020-02-12
Start date
2018-02-01
Completion date
Unknown
Last updated
2020-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Presbyopia Eye Diseases Presbyopia

Interventions

Participants will be wearing two different MF CL (Test - CVI MF, Control - 1DAVM). Their eyes will be examined by the investigator and they will be fitted with a pair of the first type of multifocal c

Sponsors

CooperVision (United States)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Contacts

Public ContactKishan Patel
kpatel@otg.co.uk+44 (0)20 7222 4224

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026