Clinical trial NCT02094677: Daily Disposable Comparison Study
Official title: Daily Disposable Comparison Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2014-03-24
Enrollment: 70
Sex: ALL
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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;

Primary outcomes:
measure: Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
timeFrame: Baseline visit
measure: Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
timeFrame: 3 hours
measure: Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A
timeFrame: 6 hours
Secondary outcomes:
measure: Lens Comfort - Filcon II 3 and Etafilcon A
timeFrame: Baseline, 3 hours, 6 hours
measure: Lens Comfort - Filcon II 3 and Nelficon A
timeFrame: Baseline, 3 hours, 6 hours
measure: Lens Dryness - Filcon II 3 and Etafilcon A
timeFrame: 3 hours and 6 hours
measure: Lens Dryness - Filcon II 3 and Nelfilcon A
timeFrame: 3 hours and 6 hours
measure: Lens Handling - Filcon II 3 and Etafilcon A
timeFrame: Baseline visit
measure: Lens Handling - Filcon II 3 and Nelfilcon A
timeFrame: Baseline visit
measure: Lens Handling (Removal) - Filcon II 3 and Etafilcon A
timeFrame: 6 hours
measure: Lens Handling (Removal) - Filcon II 3 and Nelfilcon A
timeFrame: 6 hours
measure: Lens Wettability - Filcon II 3 and Etafilcon A
timeFrame: Baseline and 6 hours
measure: Lens Wettability - Filcon II 3 and Nelfilcon A
timeFrame: Baseline and 6 hours
measure: Lens Fit, Centration - Filcon II 3 and Etafilcon A
timeFrame: Baseline
measure: Lens Fit, Centration - Filcon II 3 and Etafilcon A
timeFrame: 6 hours
measure: Lens Fit, Centration - Filcon II 3 and Nelfilcon A
timeFrame: Baseline
measure: Lens Fit, Centration - Filcon II 3 and Nelfilcon A
timeFrame: After 6 hours
measure: Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A
timeFrame: Baseline and 6 hours
measure: Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A
timeFrame: Baseline and 6 hours
measure: Lens Fit, Tightness - Filcon II 3 and Etafilcon A
timeFrame: Baseline and 6 hours
measure: Lens Fit, Tightness - Filcon II 3 and Nelfilcon A
timeFrame: Baseline and 6 hours
measure: Lens Surface Deposition - Filcon II 3 and Etafilcon A
timeFrame: 6 hour
measure: Lens Surface Deposition - Filcon II 3 and Nelfilcon A
timeFrame: 6 hour
measure: High Contrast Visual Acuity - Filcon II 3 and Etafilcon A
timeFrame: Baseline and 6 hours
measure: High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A
timeFrame: Baseline and 6 hours
measure: Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A
timeFrame: 6 hours
measure: Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A
timeFrame: 6 hours
measure: Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A
timeFrame: Baseline and 6 hours
measure: Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A
timeFrame: Baseline and 6 hours
Other outcomes:
Locations:
city: Waterloo
country: Canada
facility: Centre for Contact Lens Research
state: Ontario
Study officials:
References: