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NCT04831515

Performance Evaluation of Two Daily Disposable Toric Lens Designs in Habitual Soft Contact Lens Wearers

Completed NA Results posted Last updated 15 February 2022
What this trial tests

NA trial testing Lens A in Astigmatism in 48 participants. Completed in 2 July 2021.

Timeline
29 March 2021
Primary endpoint
2 July 2021
2 July 2021

Quick facts

Lead sponsorCooperVision, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment48
Start date29 March 2021
Primary completion2 July 2021
Estimated completion2 July 2021
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

CooperVision, Inc.

Who can join

18 and older, any sex, with Astigmatism. 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 Ease of Lens Handling Primary · 1 week

Ease of overall lens handling for putting on eyes, removing from eyes, and opening packaging will be measured on a 0-10 integer scale (0=Very difficult, 10-Very easy)

GroupValue95% CI
Lens A9.0± 1.1
Lens B8.8± 1.5
Visual Acuity Secondary · Baseline - after lenses have settled for 10 minutes

Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)

GroupValue95% CI
Lens A-0.06± 0.06
Lens B-0.06± 0.06
Visual Acuity Secondary · 1 week

Visual acuity will be measured using LogMAR scale in high room illumination high contrast: distance (≥4m)

GroupValue95% CI
Lens A-0.06± 0.06
Lens B-0.05± 0.06

Adverse events — posted to ClinicalTrials.gov

Time frame: From dispense up to 1 week on each study lenses for a total of 2 weeks. Reporting threshold: 1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Lens A
Serious: 0/48 (0%)
Deaths: 0/48
Lens B
Serious: 0/48 (0%)
Deaths: 0/48
Other adverse events (1 terms — click to expand)

ReactionSystemLens ALens B
inferior single corneal peripheral ulcerEye disorders

Data from ClinicalTrials.gov NCT04831515 adverse events section.

Sponsor's own description

The objective of the study is to compare the clinical performance of two different daily disposable, SiHy toric contact lens types, Lens A and Lens B, in existing soft lens wearers when worn for one week each.

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

Trials testing the same drug.

Other recruiting trials for Astigmatism

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/NCT04831515.

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