N/A
Completed N=36
A Contralateral Dispensing Clinical Trial of Study Test Sapphire Lens Against Enfilcon A Silicone Hydrogel Lens
Source: ClinicalTrials.gov NCT02518490 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Sep 2020
Primary outcomePrimary: Subjective Ratings for Comfort After Lens Insertion — 91; 93 units on a scale
Summary
This was be a randomized, contralateral, double-masked, dispensing study comparing the Study test lens against the control lens over one month of lens wear.
The study results were not used for design validation of test lens.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Subjective Ratings for Comfort After Lens Insertion |
88; 87 | — |
| PRIMARY Percentage of Participants With a Lens Preference Based on Subjective Comfort |
10; 65; 25 | — |
| PRIMARY Lens Wettability |
3.5; 3.6 | — |
| PRIMARY Lens Surface Deposition |
0.21; 0.10 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects will only be eligible for the study if:
- Is at least 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 -6.50 diopters sphere;
- 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
- Subjects will not be eligible to take part in the study if:
- 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; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
Data sourced from ClinicalTrials.gov (NCT02518490). 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.