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N/A Completed N=35 Randomized Double-blind Treatment

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

OutcomeResultp-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.
View full record on ClinicalTrials.gov →

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.

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