N/A
Completed N=30
Clinical Validation of Biofinity Toric MTO (Made To Order) Lenses
Myopia · Astigmatism
Source: ClinicalTrials.gov NCT02185105 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2017
Primary outcomePrimary: Lens Surface Assessment of Study Lenses - Surface Wettability — 3.4; 3.4; 3.4; 3.4 units on a scale
Summary
The study hypothesis is there is no difference in the clinical performance between the test and control lenses, in particular in lens stability, toric mislocation, comfort ratings and anterior segment ocular health findings.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Surface Assessment of Study Lenses - Surface Wettability |
3.4; 3.4; 3.4; 3.4 | — |
| PRIMARY Lens Surface Assessment of Study Lenses - Deposits |
0.00; 0.00; 0.03; 0.00 | — |
| PRIMARY Lens Surface Assessment of Study Lenses - Surface Acceptance |
3.4; 3.4; 3.4; 3.4 | — |
| PRIMARY Subjective Rating For Comfort - Comfort Since Last Visit |
88; 90; 84; 87; 84; 88 | — |
| PRIMARY Subjective Rating For Comfort Preference |
23; 47; 30; 23; 47; 30 | — |
| PRIMARY Subjective Rating For Handling - Insertion |
95; 95 | — |
| PRIMARY Subjective Rating For Handling - Removal |
63; 74 | — |
| PRIMARY Investigator's Assessment of Stability |
3; 3; 3; 4 | — |
| PRIMARY General Lens Fit - Fit Acceptance |
3.4; 3.4; 3.4; 3.4 | — |
| PRIMARY Lens Fitting - Rotation/Mislocation |
1; 3; 1; 1; 2; -1 | — |
| PRIMARY Anterior Ocular Health - Corneal Staining (Central) |
0.02; 0.02; 0.00; 0.00 | — |
| PRIMARY Anterior Ocular Health - Corneal Staining (Nasal) |
0.02; 0.05; 0.00; 0.00 | — |
| PRIMARY Anterior Ocular Health - Corneal Staining (Temporal) |
0.02; 0.05; 0.00; 0.00 | — |
| PRIMARY Anterior Ocular Health - CornealStaining (Superior) |
0.00; 0.03; 0.02; 0.00 | — |
| PRIMARY Anterior Ocular Health - Corneal Staining (Inferior) |
0.12; 0.05; 0.13; 0.28 | — |
| PRIMARY Anterior Ocular Health - Conjunctival Staining (Nasal) |
0.20; 0.13; 0.20; 0.23 | — |
| PRIMARY Anterior Ocular Health - Conjunctival Staining (Superior) |
0.00; 0.00; 0.00; 0.03 | — |
| PRIMARY Anterior Ocular Health - Conjunctival Staining (Temporal) |
0.07; 0.00; 0.07; 0.13 | — |
| PRIMARY Anterior Ocular Health - Conjunctival Staining (Inferior) |
0.03; 0.00; 0.10; 0.10 | — |
Eligibility Criteria
Inclusion Criteria
- Has had a self-reported 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 20/40 or better (in each eye) with their habitual vision correction or 20/20 best-corrected.
- Currently wears soft contact lenses.
- Has clear corneas and no active ocular disease.
- Has not worn lenses for at least 12 hours before the examination
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 severe insufficiency of lacrimal secretion (moderate to severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities, active neovascularization or any central corneal scars.
- Is aphakic.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT02185105). 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.