N/A
Completed N=90
Multi-Center Clinical Evaluation of Two Reusable Soft Contact Lenses
Source: ClinicalTrials.gov NCT02542072 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Mar 2017
Primary outcomePrimary: Comfort — 8.85; 9.06; 8.71; 8.84 units on a scale
Summary
The purpose of this study is to compare the subjective performance of comfilcon A lens against samfilcon A lens after 4 weeks of reusable lens wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Comfort |
8.85; 9.06; 8.71; 8.84; 8.60; 7.72 | — |
| SECONDARY Comfortable Wearing Time Via SMS (Short Message Service) |
8.59; 8.82; 8.90; 8.84; 8.98; 8.51 | — |
| SECONDARY Wearing Times |
6.16; 13.94; 13.68; 13.90; 13.93; 12.79 | — |
| SECONDARY Deterioration in Comfort |
47; 51; 46; 53; 52; 43 | — |
| SECONDARY Vision Quality |
9.31; 9.06; 8.49; 8.81; 8.34 | — |
| SECONDARY Overall Lens Handling |
9.31; 9.12; 8.96; 9.18; 8.83; 9.31 | — |
| SECONDARY Biomicroscopy Scores |
0.39; 0.42; 0.45; 0.47; 0.49; 0.67 | — |
| SECONDARY Lens Surface Wetting |
3.69; 3.61; 3.51; 3.37; 3.27; 3.22 | — |
| SECONDARY Film Deposits |
0.12; 0.26; 0.35; 0.30 | — |
| SECONDARY White Spot Deposits |
0.3; 0.4; 0.8; 0.7 | — |
| SECONDARY Visual Acuity (VA) |
-0.03; -0.04; -0.01; -0.03; -0.02; -0.07 | — |
| SECONDARY Lens Centration |
173; 153; 162; 152; 163; 156 | — |
| SECONDARY Corneal Coverage |
100.0; 100.0; 100.0; 100.0; 100.0; 100.0 | — |
| SECONDARY Post-Blink Movement |
1.91; 1.86; 1.84; 1.79; 1.87; 1.69 | — |
| SECONDARY Primary Gaze Lag |
1.89; 1.82; 1.78; 1.69; 1.88; 1.71 | — |
| SECONDARY Lens Tightness Push-up |
48.9; 54.3; 50.6; 54.1; 50.3; 54.6 | — |
| SECONDARY Overall Fit Acceptance |
3.71; 3.63; 3.73; 3.63; 3.78; 3.66 | — |
| SECONDARY Dryness |
8.06; 7.98; 7.46; 7.71; 7.18; 7.57 | — |
Eligibility Criteria
Inclusion:
- Spherical distance Contact Lens prescription between -1.00 and -6.00D or +1.00 to +4.00D in both eyes (inclusive)
- Adapted soft Contact Lens wearers (i.e. >1 month), daily disposable and reusable lens wearers.
- Spectacle cylinder 0.75D in both eyes.
- Correctable to 6/9 (20/30) in both eyes
- Be between 18 and 50 years of age (inclusive)
- Able to read, comprehend and sign an informed consent
- Own a mobile phone and be willing to respond to Short Message Service (SMS) survey
- Willing to comply with the wear and study visit schedule
Exclusion:
- Existing Biofinity or Ultra wearers
- Any active corneal infection, injury or inflammation
- Systemic or ocular allergies, which might interfere with Contact Lens wear
- Systemic disease, which might interfere with Contact Lens wear
- Ocular disease, which might interfere with Contact Lens wear
- Strabismus or amblyopia
- Subjects who have undergone corneal refractive surgery
- Subjects with keratoconus or other severe corneal irregularity contraindicating lens wear
- Pregnant or lactating
- Use of systemic/topical medication contraindicating Contact Lens wear
- Diabetic
- Site employees or family members of site employees
Data sourced from ClinicalTrials.gov (NCT02542072). 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.