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NCT05166902

Evaluation of Monthly Replacement Lenses in Habitual Soft Contact Lens Wearers Who Report Frequent Digital Devise Use

Completed NA Results posted Last updated 27 July 2023
What this trial tests

NA trial testing Lens A (comfilcon A lens) in Ametropia in 67 participants. Completed in 9 July 2022.

Timeline
31 January 2022
Primary endpoint
9 July 2022
9 July 2022

Quick facts

Lead sponsorCooperVision, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment67
Start date31 January 2022
Primary completion9 July 2022
Estimated completion9 July 2022
Sites4 locations across Canada, United States

Drugs / interventions tested

Conditions studied

Sponsor

CooperVision, Inc.

Who can join

Adults 18 to 35, any sex, with Ametropia. 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.

Subjective Ratings on Lens Handling on Removal Primary · Day 27

Subjective ratings on lens handling on removal will be measured on a scale of 0-10, 0.5 steps (10= Very Easy, 0= Very Difficult)

GroupValue95% CI
Lens A8.3± 1.8
Lens B8.8± 1.2

Adverse events — posted to ClinicalTrials.gov

Time frame: From dispense up to one month on each study lens, for total of two months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lens A
Serious: 0/66 (0%)
Deaths: 0/66
Lens B
Serious: 0/66 (0%)
Deaths: 0/66
Other adverse events (3 terms — click to expand)

ReactionSystemLens ALens B
COVID-19Social circumstances
Lens discomfortProduct Issues
SinusInfections and infestations

Data from ClinicalTrials.gov NCT05166902 adverse events section.

Sponsor's own description

To evaluate the clinical performance of two monthly silicone hydrogel contact lenses in habitual wearers of frequent replacement (FRP) lenses when worn for 1-month.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Lens A (comfilcon A lens)

Trials testing the same drug.

Other recruiting trials for Ametropia

Currently open trials in the same condition.

Other CooperVision, Inc. trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05166902.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing