N/A
Completed N=34
A Bilateral Dispensing Clinical Trial of Sapphire Lens Against Senofilcon A Lens Over 2 Weeks
Source: ClinicalTrials.gov NCT02345811 ↗Enrolled (actual)
34
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Vision Quality — 93; 94 units on a scale
Summary
To evaluate the clinical performance of an investigational silicone-hydrogel lens when worn on a daily wear modality over two weeks of lens wear.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Vision Quality |
86; 87 | — |
| PRIMARY Vision Quality |
86; 87 | — |
| PRIMARY Vision Quality |
86; 87 | — |
| PRIMARY Subjective Rating for Comfort. |
66; 81 | — |
| PRIMARY Subjective Rating for Comfort. |
66; 81 | — |
| PRIMARY Subjective Rating for Comfort. |
66; 81 | — |
| PRIMARY Lens Surface Wettability |
3.0; 3.2 | — |
| PRIMARY Lens Surface Wettability |
3.0; 3.2 | — |
| PRIMARY Surface Deposits |
0.45; 0.40 | — |
| PRIMARY Surface Deposits |
0.45; 0.40 | — |
| PRIMARY Lens Handling (Ease of Insertion) |
93; 95 | — |
| PRIMARY Lens Handling (Ease of Removal) |
90; 95 | — |
| PRIMARY Subjective Preference for Comfort. |
23; 68; 9 | — |
| PRIMARY Subjective Preference for Comfort. |
23; 68; 9 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age for Canada and 18 years of age for the USA and has full legal capacity to volunteer
- Has read and signed an information consent letter
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is an adapted soft contact lens wearer
- Requires spectacle lens powers between -0.50 to -6.00 diopters sphere (0.25D steps) or +1.00 to +8.00 diopters sphere (1.00D steps)
- Has no more than 0.75 diopters of refractive astigmatism
- Willing to wear contact lens in both eyes
- Has manifest refraction visual acuities (VA) equal to or better than logMAR equivalent of 20/25 in each eye
- To be eligible for lens dispensing, the subject must have VA of logMAR equivalent of 20/30 or better in each eye with the study lenses and the investigator must judge the fit as acceptable
Exclusion Criteria
- Is participating in any concurrent clinical or research study
- Has any known active* ocular disease and/or infection
- Has a systemic condition that in the opinion of the investigator may affect a study outcome variable
- Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit)
- Is aphakic
- Has undergone refractive error surgery
Data sourced from ClinicalTrials.gov (NCT02345811). 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.