N/A
Completed N=60
Clinical Performance of Biofinity Toric Versus Air Optix for Astigmatism
Astigmatism
Source: ClinicalTrials.gov NCT01965288 ↗
Enrolled (actual)
60
Serious AEs
0.0%
Results posted
Nov 2014
Primary outcomePrimary: Daily and Comfortable Wearing Time — 8.8; 9.2 hours
Summary
The aim of this study is to compare the clinical performance of the Biofinity Toric (comfilcon A) contact lens, versus Air Optix for Astigmatism (lotrafilcon B) over 1 month of daily wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Daily and Comfortable Wearing Time |
9.5; 7.8; 9.9; 9.8 | — |
| PRIMARY Comfort, Dryness, Handling, Lens Fit Stability, Vision Satisfaction |
8.6; 7.1; 8.5; 6.7; 8.6; 6.9 | — |
| PRIMARY Vision Quality Insertion, During Day, End Day |
78.5; 82.7; 80.2 | — |
| PRIMARY Vision Stability Insertion, During Day, End Day |
78.5; 83.8; 82.9 | — |
| PRIMARY Overall Sensation of Moistness |
60; 18; 27; 23; 12; 30 | — |
| PRIMARY Overall Sensation of Smoothness |
47; 13; 42; 38; 10; 28 | — |
| PRIMARY Comfort Satisfaction |
72; 27; 23; 37; 5; 27 | — |
| PRIMARY Dryness Satisfaction |
77; 23; 13; 35; 10; 32 | — |
| PRIMARY Handling Satisfaction |
42; 40; 48; 48; 10; 12 | — |
| PRIMARY Lens Fit Satisfaction |
70; 35; 25; 55; 5; 10 | — |
| PRIMARY Vision Satisfaction |
63; 35; 32; 53; 5; 12 | — |
| PRIMARY Overall Satisfaction |
65; 22; 28; 45; 7; 27 | — |
| PRIMARY Comfort Upon Contact Lens Insertion |
9.0; 7.8 | — |
| PRIMARY Vision Satisfaction Upon Contact Lens Insertion |
8.8; 8.2 | — |
| PRIMARY Vision Quality With Contact Lens Prescription |
88; 82 | — |
| PRIMARY Vision Stability Upon Contact Lens Insertion |
87; 82 | — |
| PRIMARY Visual Acuity logMAR |
-0.01; -0.01; 0.19; 0.19; -0.03; -0.03 | — |
| PRIMARY Centration |
93; 81; 7; 19 | — |
| PRIMARY Corneal Coverage |
100; 100 | — |
| PRIMARY Post Blink Movement |
0.01; 0.05 | — |
| PRIMARY Lens Orientation Primary Gaze |
0.87; 1.08 | — |
| PRIMARY Lens Marking Visibility |
84; 20; 16; 50; 0; 30 | — |
| PRIMARY Lens Stability on Blink |
100; 99; 0; 1 | — |
| PRIMARY Lens Stability 5-10 Min |
100; 100 | — |
| PRIMARY Lens Overall Stability |
80; 50; 20; 50 | — |
| PRIMARY Rotational Recovery 30/45 Deg |
0.33; 0.66; 0.45; 0.63 | — |
| PRIMARY Overall Fit Acceptance |
73; 44; 27; 56 | — |
| PRIMARY Participants Use of Rewetting Drops |
15; 58 | — |
| PRIMARY Vision Quality Insertion, During Day, End Day, Night |
85; 79; 88; 82; 86; 80 | — |
| PRIMARY Vision Stability on Insertion, During Day, End Day |
85; 80; 87; 82; 86; 80 | — |
| PRIMARY Wavefront Aberrations Root Mean Square (RMS) (3mm) |
0.065; 0.07; 0.043; 0.046; 0.034; 0.029 | — |
| PRIMARY Wavefront Aberrations RMS (3mm) |
0.071; 0.075; 0.047; 0.05; 0.033; 0.03 | — |
| PRIMARY Wavefront Aberrations RMS (5mm) |
0.261; 0.287; 0.161; 0.167; 0.075; 0.081 | — |
| PRIMARY Lens Surface Deposits |
0.41; 0.71 | — |
| PRIMARY Overall Stability |
72; 36; 28; 64 | — |
| SECONDARY Limbal Hyperaemia |
98; 98; 2; 2; 0; 0 | — |
| SECONDARY Bulbar Hyperaemia |
100; 94; 0; 6; 0; 0 | — |
| SECONDARY Lower Palpebral Hyperaemia |
93; 78; 7; 20; 0; 2 | — |
| SECONDARY Corneal Stromal Haze |
100; 100; 0; 0; 0; 0 | — |
| SECONDARY Corneal Neovascularization |
100; 97; 0; 3; 0; 0 | — |
| SECONDARY Corneal Infiltrates |
100; 100; 0; 0; 0; 0 | — |
| SECONDARY Participant Preference for Their Habitual Lenses or the First Study Lenses (Lotrafilcon B) |
62; 38; 58; 42; 57; 43 | — |
| SECONDARY Participant Preference for Their Habitual Lenses or the First Study Lenses (Comfilcon A) |
20; 80; 22; 78; 52; 48 | — |
| SECONDARY Participants Likelihood of Switching From Habitual Lenses to the Study Lenses |
45; 10; 32; 32; 22; 42 | — |
| SECONDARY Participants Likelihood of Continuing to Wear the Study Lenses. |
45; 12; 32; 30; 22; 42 | — |
| SECONDARY Participant Recommendation of a Study Lens to Friends, Family or Colleagues |
77; 23 | — |
| SECONDARY Participant Likelihood of Recommending a Study Lens to Friends, Family or Colleagues. |
52; 15; 35; 40; 11; 35 | — |
| SECONDARY Participant Preference for Their Habitual Lenses or Either of the Study Lenses |
72; 15; 13; 68; 17; 15 | — |
| SECONDARY Participant Preference for Either of the Study Lenses |
80; 20; 0; 80; 20; 0 | — |
Eligibility Criteria
Inclusion Criteria
A person is eligible for inclusion in the study if he/she:
- Is between 18 and 40 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted soft toric contact lens wearer
- Has a contact lens spherical prescription between +6.00 to - 10.00 (inclusive)
- Have no less than 0.75diopter (D) of astigmatism and no more than 2.25D in both eyes.
- Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
- Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
- Has clear corneas and no active ocular disease
- Has read, understood and signed the information consent letter.
- Patient contact lens refraction should fit within the available parameters of the study lenses.
- Is willing to comply with the wear schedule (at least 5 days per week, > 8 hours/day assuming there are no contraindications for doing so).
- Is willing to comply with the visit schedule
Exclusion Criteria
A person will be excluded from the study if he/she:
- Has a contact lens prescription outside the range of the available parameters of the study lenses.
- Has a spectacle cylinder less than -0.75D or more than -2.25 D of cylinder in either eye.
- Has a history of not achieving comfortable contact lens wear (5 days per week; > 8 hours/day)
- Has contact lens best corrected distance vision worse than 20/25 (0.10 logMAR) in either eye.
- Presence of clinically significant (grade 2-4) anterior segment abnormalities
- Presence of ocular or systemic disease or need of medications which might interfere with contact lens wear.
- Slit lamp findings that would contraindicate contact lens wear such as:
- Pathological dry eye or associated findings
- Pterygium, pinguecula, or corneal scars within the visual axis
- Neovascularization > 0.75 mm in from of the limbus
- Giant papillary conjunctivitis (GCP) worse than grade 1
- Anterior uveitis or iritis (past or present)
- Seborrheic eczema, Seborrheic conjunctivitis
- History of corneal ulcers or fungal infections
- Poor personal hygiene
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has Presbyopia or has dependence on spectacles for near work over the 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 (NCT01965288). 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.