N/A
Completed N=15
Multicenter Dispensing Study of Biofinity Toric Made-To-Order Lenses in Extended Power Ranges
Myopia · Astigmatism
Source: ClinicalTrials.gov NCT02193178 ↗
Enrolled (actual)
15
Serious AEs
0.0%
Results posted
Feb 2017
Primary outcomePrimary: Overall Comfort — 80; 91; 88 units on a scale
Summary
The study hypothesis is that the Biofinity Toric XR lenses will perform as well as or better than the participants' habitual contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Comfort |
80; 91; 88 | — |
| PRIMARY Overall Vision |
75; 85; 80 | — |
| PRIMARY Handling |
88; 89; 94 | — |
| PRIMARY Overall Satisfaction |
90; 92; 89 | — |
| PRIMARY Lens Fit - Rotation |
18; 29; 21; 64; 71; 64 | — |
| PRIMARY Lens Fit - Overall Stability |
2.8; 3.3; 3.3 | — |
| PRIMARY Lens Fit Acceptance |
3.0; 3.5; 3.3 | — |
| PRIMARY Anterior Ocular Health - Palpebral Hyperemia and Roughness |
0.75; 0.48; 0.71; 0.50; 0.61; 0.58 | — |
| PRIMARY Anterior Ocular Health - Bulbar and Limbal Redness |
1.00; 0.67; 1.00; 0.67; 0.79; 0.63 | — |
| PRIMARY Anterior Ocular Health - Corneal Staining |
0.00; 0.00; 0.11; 0.04; 0.00; 0.00 | — |
| PRIMARY Anterior Ocular Health - Conjunctival Staining and Indentation |
0.34; 0.21; 0.54; 0.37; 0.23; 0.11 | — |
| PRIMARY Visual Acuity |
0.06; 0.06; 0.07; -0.04; 0.00; -0.03 | — |
| PRIMARY Subjective Preference - Comfort |
57; 69; 43; 23; 0; 8 | — |
| PRIMARY Preference - Vision |
50.0; 46.2; 28.6; 15.4; 21.4; 38.5 | — |
| PRIMARY Preference - Handling |
21.4; 31; 64.3; 54; 7.1; 15 | — |
| PRIMARY Overall Preference |
50; 46; 43; 23; 7; 31 | — |
| PRIMARY Investigator Acceptability |
86; 85; 14; 15; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Has had an oculo-visual examination in the last two years
- Is at least 18 years of age and has full legal capacity to volunteer
- Has read and understood the information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule
- Is correctable to a visual acuity of 20/50 or better (in at least one eye)
- Currently wears soft toric contact lenses in both eyes
- Subject contact lens prescription must fall under one of the contact lens power ranges for at least one eye:
- -20.00D to -10.50D spherical powers and cylinder powers from - 0.75 to -2.25
- +8.50D to +20.00D spherical powers and cylinder powers from - 0.75 to -2.25
- -20.00D to -6.50D spherical powers and cylinder powers from -2.75 to -5.75
- -6.00D to +6.00D spherical powers and cylinder powers from -2.75 to -5.75
- +6.50D to +20.00D spherical powers and cylinder powers from-2.75 to -5.75
- Has clear corneas and no active ocular disease
- Demonstrates an acceptable fit with the study lenses
Exclusion Criteria
- Has never worn contact lenses before;
- Has any systemic disease affecting ocular health;
- Is using any systemic or topical medications that will affect ocular health;
- Has any ocular pathology or abnormality that would affect the wearing of contact lenses;
- Has undergone corneal refractive surgery;
- Is participating in any other type of eye related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT02193178). 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.