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NCT01482819

Evaluation of Daytime Corneal Swelling During Wear of Galyfilcon A Lenses

Completed NA Results posted Last updated 19 June 2018
What this trial tests

NA trial testing galyfilcon A in Myopia in 21 participants. Completed in 1 December 2011.

Timeline
1 October 2011
Primary endpoint
1 December 2011
1 December 2011

Quick facts

Lead sponsorJohnson & Johnson Vision Care, Inc.
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designfactorial
Maskingsingle
Primary purposetreatment
Enrollment21
Start date1 October 2011
Primary completion1 December 2011
Estimated completion1 December 2011
Sites1 location across Australia

Drugs / interventions tested

Conditions studied

Sponsor

Johnson & Johnson Vision Care, Inc. — full company profile →

Who can join

18 and older, any sex, with Myopia. 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.

Corneal Swelling Primary · after 8 hours of lens wear

measured in microns using the Optical Low Coherence Reflectometry (OLCR) Pachymeter. This pachymeter gives corneal thickness measurements to the accuracy of 1 micron (µm)

GroupValue95% CI
Spectacles569.42± 36.0709
Galyfilcon A Plus574.64± 39.7804
Galyfilcon A575.57± 37.6229
Lotrafilcon A578.99± 41.4960
Polymacon573.79± 36.1644
Limbal Redness Primary · after 8 hours of lens wear

grade scale of 0 to 4, where 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe; reported as an average grade.

GroupValue95% CI
Spectacles0.66± 0.2479
Galyfilcon A Plus0.83± 0.3023
Galyfilcon A0.77± 0.3085
Lotrafilcon A0.91± 0.3087
Polymacon1.14± 0.3363
Endothelia Blebs Primary · after 20 minutes of lens wear

0 to 100% of area; measured as a percentage of corneal area with blebs.

GroupValue95% CI
Spectacles4.97± 3.3703
Galyfilcon A Plus8.86± 3.9396
Galyfilcon A10.93± 6.6020
Lotrafilcon A10.31± 6.6747
Polymacon8.50± 3.6000

Sponsor's own description

The purpose of this study is to evaluate corneal swelling, limbal redness, and endothelial bleb response to wearing galyfilcon A lenses in asian eyes.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Polyphenolic Composition of Crataegus monogyna Jacq.: From Chemistry to Medical Applications.
    Nabavi SF, Habtemariam S, Ahmed T, Sureda A, et al · · 2015 · cited 48× · PMID 26378574 · DOI 10.3390/nu7095361

Verify or expand the search:

Other recruiting trials for Myopia

Currently open trials in the same condition.

Other Johnson & Johnson Vision Care, 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/NCT01482819.

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