N/A
Completed N=51
A Clinical Comparison of Three Soft Daily Disposable Contact Lenses
Source: ClinicalTrials.gov NCT02920983 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jun 2019
Primary outcomePrimary: Ocular Physiology — 0.76; 0.79; 0.78; 0.63 units on a scale
Summary
This study aims to compare the clinical performance of the somfilcon A, nelfilcon A II 2 and omafilcon A II 2 daily disposable contact lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Physiology |
0.76; 0.79; 0.78; 0.63; 0.66; 0.65 | — |
| SECONDARY Lens Fit - Horizontal Centration |
0; 0; 0; 1; 3; 1 | — |
| SECONDARY Lens Fit - Vertical Centration |
0; 0; 0; 11; 20; 22 | — |
| SECONDARY Lens Fit - Corneal Coverage |
0; 0; 0; 3; 7; 4 | — |
| SECONDARY Lens Fit - Movement |
0; 0; 0; 3; 19; 12 | — |
| SECONDARY Lens Surface - Deposition |
46; 47; 48; 3; 1; 1 | — |
| SECONDARY Lens Surface - Wettability |
37; 44; 43; 9; 3; 3 | — |
| SECONDARY Visual Acuity |
-0.11; -0.13; -0.11; 0.18; 0.17; 0.18 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects will only be eligible for the study if:
- They are of legal age (18) and capacity to volunteer.
- They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They agree not to participate in other clinical research for the duration of this study.
- They have a contact lens spherical prescription between -1.00 to - 6.00D (Diopters) (inclusive)
- They have a spectacle cylindrical correction of -0.75D or less in each eye.
- At dispensing, they can attain at least 0.10 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- They currently use soft contact lenses or have done so in the previous six months.
- They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
Exclusion Criteria
- Subjects will not be eligible to take part in the study if:
- They have an ocular disorder which would normally contra-indicate contact lens wear.
- They have a systemic disorder which would normally contra-indicate contact lens wear.
- They are using any topical medication such as eye drops or ointment.
- They have had cataract surgery.
- They have had corneal refractive surgery.
- They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
- They are pregnant or breast-feeding.
- They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
- They have any infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or they have any immunosuppressive disease (e.g. HIV), or a history of anaphylaxis or severe allergic reaction.
- They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Data sourced from ClinicalTrials.gov (NCT02920983). 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.