N/A
Completed N=106
Daily Disposable Silicone Hydrogel Contact Lens, Stenfilcon A, Clinical Study
Source: ClinicalTrials.gov NCT02637804 ↗Enrolled (actual)
106
Serious AEs
0.0%
Results posted
Oct 2017
Primary outcomePrimary: Pain and Foreign Body Sensation — 89; 79; 83; 87 eyes
Summary
Clinical evaluation of stenfilcon A compared with narafilcon A and delefilcon A
This is a total 120 subject, randomized, open label, bilateral wear, two week crossover study (each lens for 1 week) evaluating the clinical performance of stenfilcon A spherical lenses compared to narafilcon A or delefilcon A spherical lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain and Foreign Body Sensation |
89; 79; 83; 87; 21; 28 | — |
| PRIMARY Itching Sensation on Removal |
98; 102; 92; 90; 9; 8 | — |
| PRIMARY Red Eye Sensation |
98; 98; 92; 87; 12; 10 | — |
| PRIMARY Dryness |
9.56; 9.40; 9.84; 9.76; 7.37; 7.70 | — |
| PRIMARY Comfort |
9.22; 9.16; 9.67; 9.69; 8.00; 8.17 | — |
| PRIMARY Vision |
9.29; 9.32; 9.66; 9.57; 8.46; 8.52 | — |
| PRIMARY Handling |
9.07; 9.64; 9.27; 9.33; 8.63; 9.32 | — |
| PRIMARY Lens Preference - Stenfilcon A/Narafilcon A (Group 1) |
15; 12; 5; 10; 13 | — |
| PRIMARY Lens Preference - Stenfilcon A/Delefilcon A (Group 2) |
14; 8; 3; 9; 17 | — |
| SECONDARY Lens Fit - Horizontal Centration |
0; 0; 0; 0; 0; 8 | — |
| SECONDARY Lens Fit - Vertical Centration |
0; 0; 0; 0; 0; 7 | — |
| SECONDARY Lens Fit - Post-blink Movement |
0; 2; 0; 0; 0; 10 | — |
| SECONDARY Lens Fit Overall |
102; 75; 98; 95; 8; 30 | — |
| SECONDARY Conjunctival Redness |
104; 99; 100; 100; 6; 11 | — |
| SECONDARY Limbal Redness |
110; 106; 102; 99; 0; 4 | — |
| SECONDARY Corneal Staining |
83; 69; 71; 70; 25; 39 | — |
| SECONDARY Corneal Neovascularization |
108; 108; 102; 102; 2; 2 | — |
| SECONDARY Conjunctival Staining |
75; 67; 76; 80; 28; 29 | — |
| SECONDARY Corneal Oedema |
110; 110; 102; 102; 0; 0 | — |
| SECONDARY Papillary Conjunctivitis |
110; 110; 102; 102; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- A person is eligible for inclusion in the study if he/she:
- Is over 18 years of age (inclusive)
- Has had a self-reported visual exam in the last two years
- Is an adapted daily disposable non-silicone hydrogel spherical contact lens wearer
- Can achieve best corrected spectacle distance visual acuity of 20/25 or better in each eye.
- Can achieve a distance visual acuity of 20/30 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.
- Has a CL (Contact Lens) spherical prescription between - 0.75 and - 8.00 (inclusive)
- Is willing to comply with the wear schedule.
- Is willing to comply with the visit schedule
Exclusion Criteria
- A person will be excluded from the study if he/she:
- Is not a habitual wearer of daily disposable non-silicone hydrogel spherical contact lenses
- Has a CL prescription outside the range of the inclusion power range
- Has a spectacle cylinder ≥1.00D of cylinder in either eye.
- Has a history of not achieving comfortable CL wear (5 days per week; > 8 hours/day)
- Has contact lens best corrected distance vision worse than 20/25 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
- Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
- Has aphakia, keratoconus or a highly irregular cornea.
- Has undergone corneal refractive surgery.
- Is participating in any other type of eye related clinical or research study.
Data sourced from ClinicalTrials.gov (NCT02637804). 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.