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NCT04016623

Clinical Evaluation of Invigor Toric 1-Day Contact Lenses

Completed NA Results posted Last updated 14 August 2020
What this trial tests

NA trial testing 1-day toric test contact lens in Astigmatism in 10 participants. Completed in 4 June 2019.

Timeline
6 May 2019
Primary endpoint
15 May 2019
4 June 2019

Quick facts

Lead sponsorCooperVision, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingdouble
Primary purposetreatment
Enrollment10
Start date6 May 2019
Primary completion15 May 2019
Estimated completion4 June 2019
Sites1 location 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.

Visibility of Toric Mark Primary · 1 hour

Toric Mark visible or not visible. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Visible
GroupValue95% CI
Test Contact Lenses100
Control Contact Lenses100
Not Visible
GroupValue95% CI
Test Contact Lenses0
Control Contact Lenses0
Degree of Lens Orientation Primary · Baseline

Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

GroupValue95% CI
Test Contact Lenses0± 7
Control Contact Lenses-1± 7
Degree of Lens Orientation Primary · 15 minutes

Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

GroupValue95% CI
Test Contact Lenses1± 6
Control Contact Lenses0± 7
Degree of Lens Orientation Primary · 1 hour

Average of lens toric mark mislocation from the resting toric mark away from the 6 o'clock position - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

GroupValue95% CI
Test Contact Lenses-1± 6
Control Contact Lenses-1± 6
Toric Stability Primary · 15 minutes

Toric stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

GroupValue95% CI
Test Contact Lenses4± 3
Control Contact Lenses4± 3
Toric Stability Primary · 1 hour

Rotational stability (maximal and minimal differences between extreme gazes) measured in degrees for up, down, right, and left gazes. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

GroupValue95% CI
Test Contact Lenses5± 3
Control Contact Lenses4± 3
Degree of Rotational Recovery Primary · 15 minutes

Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Nasal
GroupValue95% CI
Test Contact Lenses16± 9
Control Contact Lenses15± 10
Temporal
GroupValue95% CI
Test Contact Lenses10± 10
Control Contact Lenses10± 9
Degree of Rotational Recovery Primary · 1 hour

Rotational Recovery for nasal and temporal - measured in degrees. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Nasal
GroupValue95% CI
Test Contact Lenses16± 9
Control Contact Lenses12± 10
Temporal
GroupValue95% CI
Test Contact Lenses9± 10
Control Contact Lenses10± 10
Toric Fit Acceptance Primary · 15 minutes

Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

GroupValue95% CI
Test Contact Lenses3.5± 0.2
Control Contact Lens3.4± 0.2
Toric Fit Acceptance Primary · 1 hour

Toric fit acceptance and preference scale 0-4 (0 = can't be worn, 4 = optimum). Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

GroupValue95% CI
Test Contact Lenses3.5± 0.2
Control Contact Lenses3.4± 0.3
Toric Fit Preference Primary · Baseline

Investigator's toric fitting preference - Test lens , No Preference , Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Test Lens
GroupValue95% CI
Overall Study23
No Preference
GroupValue95% CI
Overall Study69
Control Lens
GroupValue95% CI
Overall Study8
Toric Fit Preference Primary · 1 hour

Investigator's toric fitting preference - Test lens, No Preference, Control lens. Data for all 4 pairs were combined and analyzed (n=40 contact lenses).

Test Lens
GroupValue95% CI
Overall Study33
No Preference
GroupValue95% CI
Overall Study57
Control Lens
GroupValue95% CI
Overall Study10

Sponsor's own description

An evaluation of the clinical performance of the 1-day toric test contact lens compared to the 1-day toric control contact lens over one hour of lens wear.

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 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/NCT04016623.

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