Last reviewed · How we verify

NCT04952701

Evaluating the Success of Habitual Multifocal Wearers When Refit With a New Lens Design

Completed NA Results posted Last updated 27 April 2022
What this trial tests

NA trial testing Control lenses in Presbyopia in 63 participants. Completed in 14 January 2022.

Timeline
21 October 2021
Primary endpoint
1 December 2021
14 January 2022

Quick facts

Lead sponsorCooperVision, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationnon randomized
Designcrossover
Maskingsingle
Primary purposetreatment
Enrollment63
Start date21 October 2021
Primary completion1 December 2021
Estimated completion14 January 2022
Sites5 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

CooperVision, Inc.

Who can join

42 and older, any sex, with Presbyopia. 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.

Comfort on Insertion Primary · Day 1 after Lens Dispense Visit

Subjective ratings of comfort on insertion using a 0-10 scale, in 0.5 steps (0=- painful, 10- Can't feel the lenses).

GroupValue95% CI
Control Lens9.2± 1.1
Test Lens9.2± 1.0

Adverse events — posted to ClinicalTrials.gov

Time frame: From dispense up to 2 weeks on each study lens, a total of 4 weeks.. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Control Lens
Serious: 0/63 (0%)
Deaths: 0/63
Test Lens
Serious: 0/63 (0%)
Deaths: 0/63
Other adverse events (2 terms — click to expand)

ReactionSystemControl LensTest Lens
Light SensitivityEye disorders
Eye Irritation and DiscomfortEye disorders

Data from ClinicalTrials.gov NCT04952701 adverse events section.

Sponsor's own description

The objective of the study was to adapt existing multifocal soft lens wearers to a CONTROL lens for 2 weeks and then evaluate the success of switching them to the TEST lens, with a review after 2 weeks.

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 recruiting trials for Presbyopia

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/NCT04952701.

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