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NCT03546647

Toric Contact Lens Performance Study

Completed NA Results posted Last updated 7 June 2021
What this trial tests

NA trial testing Dailies Aqua Comfort Plus Toric in Astigmatism in 35 participants. Completed in 21 December 2018.

Timeline
18 June 2018
Primary endpoint
21 December 2018
21 December 2018

Quick facts

Lead sponsorUniversity of Houston
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingdouble
Primary purposetreatment
Enrollment35
Start date18 June 2018
Primary completion21 December 2018
Estimated completion21 December 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of Houston

Who can join

Adults 18 to 39, 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.

Near Visual LogMAR Acuity Primary · 10 +/- 2 days

High contrast LogMAR visual acuity was assessed at 40 cm using the M\&S Clinical Trial Suite system (Niles, Illinois, USA). The system was calibrated according to the manufacturer's directions every day, prior to use. Testing was performed binocularly. The test started at 20/200 and continued until three letters were missed on a line.

GroupValue95% CI
Toric-0.09± 0.07
Sphere-0.02± 0.09

Adverse events — posted to ClinicalTrials.gov

Time frame: 10 ± 2 days for each intervention. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Toric
Serious: 0/34 (0%)
Deaths: 0/34
Sphere
Serious: 0/34 (0%)
Deaths: 0/34
Other adverse events (1 terms — click to expand)

ReactionSystemToricSphere
KeratitisEye disorders

Data from ClinicalTrials.gov NCT03546647 adverse events section.

Sponsor's own description

This study seeks to quantify digital visual performance and subjective visual acceptance of toric contact lenses as compared to spherical lenses in low to moderate astigmatic patients.

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 University of Houston 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/NCT03546647.

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