NCT04492397

Comparing The Performance Of Two Different Daily Disposable Lenses (MIKI)

Completed NA Results posted Last updated 23 June 2021

What this trial tests

NA trial testing Test Contact Lens in Myopia in 35 participants. Completed in 31 March 2021.

Timeline

30 September 2020

Primary endpoint
31 March 2021

31 March 2021

Quick facts

Lead sponsor	CooperVision, Inc.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	35
Start date	30 September 2020
Primary completion	31 March 2021
Estimated completion	31 March 2021
Sites	1 location across Canada

Drugs / interventions tested

• Test Contact Lens
• Control Contact Lens

Conditions studied

• Myopia — all drugs for Myopia →

Sponsor

CooperVision, Inc.

Who can join

17 and older, any sex, with Myopia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Overall Lens Fit Acceptance Primary · 1 week

Overall fit acceptance (0-4, 0.50 steps) (0 - lens should not be worn at all,1 - Borderline but unacceptable, 2 - Minimally acceptable, 3 - Not perfect but OK to dispense, 4 - Perfect)

Group	Value	95% CI
Test Contact Lens	3.71	± 0.33
Control Contact Lens	3.73	± 0.35

Lens Centration Secondary · Baseline

Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive \& occasionally encroaching limbus")

Group	Value	95% CI
Test Contact Lens	0.40	± 0.50
Control Contact Lens	0.29	± 0.52

Lens Centration Secondary · 1 week

Lens Centration was measured on a scale (0-3) (0 = "Optimally centered", 1 = "Slightly decentered", 2 = Moderate decentration but not encroaching limbus, 3 = "Excessive \& occasionally encroaching limbus")

Group	Value	95% CI
Test Contact Lens	0.17	± 0.38
Control Contact Lens	0.20	± 0.47

Post-blink Movement Secondary · Baseline

Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps

Group	Value	95% CI
Test Contact Lens	0.20	± 0.06
Control Contact Lens	0.23	± 0.06

Post-blink Movement Secondary · 1 week

Post-blink lens movement was measured using an eyepiece reticule while viewing the contact lens in-vivo at 8x magnification in primary gaze, in 0.1mm steps

Group	Value	95% CI
Test Contact Lens	0.20	± 0.05
Control Contact Lens	0.23	± 0.07

Push-up Tightness Secondary · Baseline

Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum, 100% = no movement)

Group	Value	95% CI
Test Contact Lens	51	± 5
Control Contact Lens	49	± 6

Push-up Tightness Secondary · 1 week

Push-up tightness in primary gaze measured on a scale (0-100, 5% steps) (0% = falls from cornea without lid support, 50% = optimum and 100% = no movement)

Group	Value	95% CI
Test Contact Lens	50	± 4
Control Contact Lens	48	± 4

Sponsor's own description

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

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Interventions for myopia control in children: a living systematic review and network meta-analysis.
   Lawrenson JG, Shah R, Huntjens B, Downie LE, et al · · 2023 · cited 117× · PMID 36809645 · DOI 10.1002/14651858.cd014758.pub2