N/A
Completed N=114
Evaluation Of One Silicone Hydrogel Contact Lens and Two Hydrogel Lenses in Daily Wear
Source: ClinicalTrials.gov NCT04050618 ↗Enrolled (actual)
114
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Subjective Overall Comfort Rating — 8.2; 8.6; 8.3; 8.3 units on a scale
Summary
To evaluate the comparative clinical performance of the fanfilcon A silicone hydrogel lens used in daily wear and to compare this with competitive hydrogel lens products.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Overall Comfort Rating |
7.9; 8.6 | — |
| SECONDARY Average Wearing Time |
14.21; 14.42 | — |
| SECONDARY Average Comfortable Wearing Time |
11.37; 12.40 | — |
| SECONDARY Lens Centration |
86; 89; 14; 11; 0; 0 | — |
| SECONDARY Corneal Coverage |
100; 98; 0; 2 | — |
| SECONDARY Post-Blink Movement |
0; 0; 4; 2; 80; 96 | — |
| SECONDARY Lens Tightness - Push-up Test |
48.4; 49.8 | — |
| SECONDARY Overall Lens Fit Acceptance |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Rating of Lens Surface Wettability |
3.55; 3.81 | — |
| SECONDARY Presence of Film Deposits |
74; 79; 22; 17; 2; 2 | — |
| SECONDARY Number of White Spot Deposits |
0.15; 0.18 | — |
| SECONDARY Primary Gaze Lag |
0; 0; 2; 2; 96; 106 | — |
| SECONDARY Comfort Throughout the Day |
7.79; 8.29 | — |
Eligibility Criteria
Inclusion Criteria
- Be a currently adapted soft contact lens wearer (>1 month of lens wear).
- Be at least 18 years of age.
- Refractive astigmatism Grade 3) corneal staining, corneal stromal edema, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.
- Any corneal infiltrates or any corneal scarring or neovascularization within the central 5mm of the cornea.
- Keratoconus or other corneal irregularity.
- Aphakia or amblyopia.
- Have undergone corneal refractive surgery or any anterior segment surgery.
- Abnormal lacrimal secretions.
- Has diabetes.
- Known/reported infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease (e.g., HIV).
- History of chronic eye disease (e.g. glaucoma).
- Pregnant or lactating or planning a pregnancy at the time of enrolment.
- Participation in any concurrent clinical trial or in last 30 days.
Data sourced from ClinicalTrials.gov (NCT04050618). 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.