N/A
Completed N=55
Comparison of Two Daily Disposable Soft Contact Lenses
Astigmatism Bilateral
Source: ClinicalTrials.gov NCT03779503 ↗
Enrolled (actual)
55
Serious AEs
0.0%
Results posted
Oct 2020
Primary outcomePrimary: Lens Fit - Horizontal Centration — 0; 0; 6; 4 percentage of lenses
Summary
The aim of this study was to investigate the short-term clinical performance and subjective acceptance of the two study lenses.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lens Fit - Horizontal Centration |
0; 0; 8; 6; 60; 55 | — |
| PRIMARY Lens Fit - Vertical Centration |
2; 0; 32; 26; 47; 43 | — |
| PRIMARY Lens Fit - Corneal Coverage |
2; 0; 19; 34; 72; 60 | — |
| PRIMARY Lens Fit - Lens Movement |
0; 0; 13; 11; 55; 75 | — |
| SECONDARY Subjective Score for Vision |
86.5; 91.7 | — |
Eligibility Criteria
Inclusion Criteria
- They are between 18 and 40 years of age (inclusive).
- They understand their rights as a research subject and are willing to sign a Statement of Informed Consent.
- They are willing and able to follow the protocol.
- They are an existing silicone hydrogel reusable spherical contact lens wearer in both eyes.
- They have a contact lens spherical prescription between -0.25D and -6.00D (inclusive) based on ocular refraction.
- They own a wearable pair of spectacles and wear them on the day of the initial visit.
- At dispensing, they can attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
- They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
- They agree not to participate in other clinical research for the duration of the study.
Exclusion Criteria
- 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, or use any rewetting/lubricating drops whilst on this study.
- They are aphakic.
- 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 breastfeeding.
- 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 contact lens or care system clinical research within two weeks prior to starting this study.
Data sourced from ClinicalTrials.gov (NCT03779503). 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.