Daily Disposable Comparison Study

CooperVision

Status: Completed

Conditions: Myopia

Treatments: Device: nelfilcon A; Device: etafilcon A; Device: filcon II 3

Study type: Interventional

Funder types: Industry

Identifiers

NCT02094677

EX-MKTG-50

Details and patient eligibility

About

The objective of the study is to compare the overall subjective preference between two Daily Disposable hydrogel lenses when refitted into a third hydrogel lens.

Full description

This was a two-day, randomized, non-dispensing, double-masked, contralateral study with two parallel groups. Participants were recruited into one of two groups - participants who habitually wore etafilcon A lens and participants who habitually wore nelfilcon A lens.

Enrollment: 70 patients

Sex: All

Ages: 17 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Is at least 17 years of age and has full legal capacity to volunteer;
2. Has read and signed an information consent letter;
3. Is willing and able to follow instructions and maintain the appointment schedule;
4. Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
5. Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.
6. Demonstrates an acceptable fit with the study lenses

Exclusion criteria

1. Is participating in any concurrent clinical or research study;
2. Has any known active* ocular disease and/or infection;
3. Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
4. Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
5. Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
6. Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
7. Is aphakic;
8. Has undergone refractive error surgery;

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

filcon II 3 and etafilcon A

Active Comparator group

Description:

Participants were randomized to a test and control lens for each group in a contralateral design.

Treatment:

Device: filcon II 3

Device: etafilcon A

filcon II 3 and nelfilcon A

Active Comparator group

Description:

Participants were randomized to a test and control lens for each group in a contralateral design.

Treatment:

Device: filcon II 3

Device: nelfilcon A