N/A
Completed N=74
Daily Disposable Comparison Study
Source: ClinicalTrials.gov NCT02094677 ↗Enrolled (actual)
74
Serious AEs
0.0%
Results posted
Mar 2016
Primary outcomePrimary: Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A — 1; 3; 14; 8 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Preference - Filcon II 3 and Etafilcon A or Filcon II 3 and Nelfilcon A |
2; 5; 9; 8; 7; 9 | — |
| SECONDARY Lens Comfort - Filcon II 3 and Etafilcon A |
78; 77; 84; 90; 79; 87 | — |
| SECONDARY Lens Comfort - Filcon II 3 and Nelficon A |
67; 67; 85; 88; 79; 75 | — |
| SECONDARY Lens Dryness - Filcon II 3 and Etafilcon A |
72; 70; 78; 85; 75; 82 | — |
| SECONDARY Lens Dryness - Filcon II 3 and Nelfilcon A |
66; 66; 79; 76; 77; 74 | — |
| SECONDARY Lens Handling - Filcon II 3 and Etafilcon A |
92; 92; 93; 91 | — |
| SECONDARY Lens Handling - Filcon II 3 and Nelfilcon A |
90; 90; 92; 92 | — |
| SECONDARY Lens Handling (Removal) - Filcon II 3 and Etafilcon A |
95; 95; 95; 97 | — |
| SECONDARY Lens Handling (Removal) - Filcon II 3 and Nelfilcon A |
90; 89; 94; 94 | — |
| SECONDARY Lens Wettability - Filcon II 3 and Etafilcon A |
0.40; 0.33; 0.95; 1.03 | — |
| SECONDARY Lens Wettability - Filcon II 3 and Nelfilcon A |
0.38; 0.25; 0.93; 0.73 | — |
| SECONDARY Lens Fit, Centration - Filcon II 3 and Etafilcon A |
16; 14; 0; 1; 9; 9 | — |
| SECONDARY Lens Fit, Centration - Filcon II 3 and Nelfilcon A |
11; 12; 1; 1; 4; 4 | — |
| SECONDARY Lens Fit, Post-Blink Movement - Filcon II 3 and Etafilcon A |
0.28; 0.24; 0.30; 0.26 | — |
| SECONDARY Lens Fit, Post-Blink Movement - Filcon II 3 and Nelfilcon A |
0.26; 0.24; 0.23; 0.24 | — |
| SECONDARY Lens Fit, Tightness - Filcon II 3 and Etafilcon A |
48; 50; 49; 51 | — |
| SECONDARY Lens Fit, Tightness - Filcon II 3 and Nelfilcon A |
50; 52; 52; 53 | — |
| SECONDARY Lens Surface Deposition - Filcon II 3 and Etafilcon A |
0.26; 0.37 | — |
| SECONDARY Lens Surface Deposition - Filcon II 3 and Nelfilcon A |
0.27; 0.30 | — |
| SECONDARY High Contrast Visual Acuity - Filcon II 3 and Etafilcon A |
-0.08; -0.06; -0.09; -0.07 | — |
| SECONDARY High Contrast Visual Acuity - Filcon II 3 and Nelfilcon A |
-0.07; -0.07; -0.08; -0.10 | — |
| SECONDARY Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Etafilcon A |
4; 0; 1; 1; 3; 2 | — |
| SECONDARY Ocular Health, Corneal Staining (Extent) - Filcon II 3 and Nelfilcon A |
2; 2; 1; 0; 2; 2 | — |
| SECONDARY Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Etafilcon A |
1.89; 1.81; 1.75; 1.68 | — |
| SECONDARY Ocular Health, Conjunctival Hyperemia - Filcon II 3 and Nelfilcon A |
1.67; 1.57; 1.35; 1.27 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age and has full legal capacity to volunteer;
- Has read and signed an information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is correctable to a visual acuity of 20/40 or better (in each eye) with their habitual correction and the assigned study lenses;
- Habitually wears either 1 Day Acuvue Moist or Dailies Aqua Comfort Plus contact lenses.
- Demonstrates an acceptable fit with the study lenses
Exclusion Criteria
- Is participating in any concurrent clinical or research study;
- Has any known active* ocular disease and/or infection;
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable;
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit);
- Is aphakic;
- Has undergone refractive error surgery;
Data sourced from ClinicalTrials.gov (NCT02094677). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.