N/A
Completed N=35
Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)
Source: ClinicalTrials.gov NCT04492397 ↗Enrolled (actual)
35
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Overall Lens Fit Acceptance — 3.71; 3.73 units on a scale
Summary
The objective of the study is to evaluate and compare the performance of study test lens to study control lens, when worn on a daily disposable modality over a period of approximately one week each
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall Lens Fit Acceptance |
3.71; 3.73 | — |
| SECONDARY Lens Centration |
0.17; 0.20 | — |
| SECONDARY Post-blink Movement |
0.20; 0.23 | — |
| SECONDARY Push-up Tightness |
50; 48 | — |
Eligibility Criteria
Inclusion Criteria
- Is at least 17 years of age 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;
- Habitually wears soft contact lenses in daily wear, for minimum of 6-months;
- Is correctable to a visual acuity of 20/40 or better (in each eye) with the study lenses;
- Has an astigmatism of ≤ 1.00 D in subjective refraction;
- Can be fit with study contact lenses with a power between -2.00 and -5.00 DS;
- Demonstrates an acceptable fit with the study lenses;
- Habitually wears single vision soft contact lenses for at least 8 hours per day, 5 days a week, and is willing to wear contact lenses for at least 12 hours a day in the study.
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 because the associated hormonal changes cause changes in the tear layer which impact contact lens comfort. Verbal confirmation at the screening visit is sufficient;
- Is aphakic;
- Has undergone refractive error surgery;
- Is an employee of the Centre for Ocular Research & Education;
- Has participated in the BOXER (i.e. EX-MKTG-107, phases 1 or 2) or BASSET (EXMKTG-113) Study;
- Has participated in any clinical trials within a week prior to the study.
Data sourced from ClinicalTrials.gov (NCT04492397). 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.