N/A
Completed N=19
Multicenter Dispensing Study of Biofinity Lenses in Extended Range
Source: ClinicalTrials.gov NCT02060539 ↗Enrolled (actual)
19
Serious AEs
0.0%
Results posted
Jun 2015
Primary outcomePrimary: Dryness (During Day and Dryness at Night) — 69; 53 units on a scale
Summary
To obtain subjective and objective feedback on the clinical performance of Biofinity lenses after at least two weeks daily wear in existing contact lens wearers compared with their habitual lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Dryness (During Day and Dryness at Night) |
87; 76 | — |
| PRIMARY Dryness (During Day) |
92 | — |
| PRIMARY Dryness (During Day and Dryness at Night) |
87; 76 | — |
| PRIMARY Comfort (Insertion, End of Day, Overall) |
89; 76; 86 | — |
| PRIMARY Comfort (Insertion) |
89 | — |
| PRIMARY Comfort (Insertion, End of Day, Overall) |
89; 76; 86 | — |
| PRIMARY Ghosting (Multiple Images) |
92 | — |
| PRIMARY Ghosting (Multiple Images) |
92 | — |
| PRIMARY Ghosting (Multiple Images) |
92 | — |
| PRIMARY Hazing (Blurred Edges) |
92 | — |
| PRIMARY Hazing (Blurred Edges) |
92 | — |
| PRIMARY Vision Quality (During Day and at Night) |
86; 78 | — |
| PRIMARY Vision Quality (During Day) |
87 | — |
| PRIMARY Vision Quality (During Day and at Night) |
86; 78 | — |
| PRIMARY Handling (Insertion, Removal, Overall) |
94; 83; 89 | — |
| PRIMARY Handling (Insertion, Removal, Overall) |
94; 83; 89 | — |
| PRIMARY Overall Satisfaction of Comfort, Vision, Handling |
87 | — |
| PRIMARY Overall Satisfaction of Comfort, Vision, Handling |
87 | — |
| PRIMARY Overall Satisfaction of Comfort, Vision, Handling |
87 | — |
| PRIMARY Comfort Preference |
42; 26; 32 | — |
| PRIMARY Comfort Preference |
42; 26; 32 | — |
| PRIMARY Vision Preference |
53; 31; 16 | — |
| PRIMARY Vision Preference |
53; 31; 16 | — |
| PRIMARY Handling Preference |
32; 32; 37 | — |
| PRIMARY Overall Preference |
63; 21; 16 | — |
| PRIMARY Overall Preference |
63; 21; 16 | — |
| SECONDARY Lens Centration - Habitual Lenses |
53; 37; 11 | — |
| SECONDARY Lens Centration |
63; 32; 5 | — |
| SECONDARY Lens Centration |
63; 32; 5 | — |
| SECONDARY Lens Movement - Habitual Lenses |
2.47 | — |
| SECONDARY Lens Movement |
2.45 | — |
| SECONDARY Lens Movement |
2.45 | — |
| SECONDARY Overall Fit Acceptance |
3.45 | — |
| SECONDARY Overall Fit Acceptance |
3.45 | — |
| SECONDARY Overall Fit Acceptance |
3.45 | — |
| SECONDARY Visual Acuity |
0.11; 0.18; 0.02; 0.11 | — |
| SECONDARY Visual Acuity |
0.11; 0.18; 0.02; 0.11 | — |
| SECONDARY Visual Acuity |
0.11; 0.18; 0.02; 0.11 | — |
| SECONDARY Anterior Ocular Physiological Response |
1.00; 0.74; 0.47; 0.45; 0.94; 0.9 | — |
| SECONDARY Anterior Ocular Physiological Response |
1.00; 0.74; 0.47; 0.45; 0.94; 0.9 | — |
| SECONDARY Average Wearing Time |
12.5 | — |
| SECONDARY Average Wearing Time |
12.5 | — |
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) with their habitual vision correction
- Currently wears soft contact lenses
- They should require contact lens powers between -12.00 and -20.00D or between +8.00 and +15.00D
- Has clear corneas and no active ocular disease
- Demonstrates an acceptable fit with the study lenses.
Exclusion Criteria
- Has any systemic disease affecting ocular health
- Is taking medication, such as antihistamine eye drops, oral and ophthalmic betaadrenergic blockers (e.g. Propanolol, Timolol), anticholinergics, and any prescribed or over-the-counter eye medication, except artificial tears or eye lubricants
- Have any active ocular disease and/or infection that would contraindicate contact lens wear.
- Active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
- Has worn gas permeable contact lenses within the last month.
- Is aphakic
- Has undergone corneal refractive surgery.
- Is participating in any other type of clinical research study
- Female who is currently pregnant or is breast-feeding.
Data sourced from ClinicalTrials.gov (NCT02060539). 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.