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Effect of Head and Gaze Position on Soft Toric Contact Lens Performance

NCT01579045 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2018-06-19

Study results available
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Summary

Primary Hypotheses:

Senofilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 monthly .

Etafilcon A will provide significantly less rotation with subjects in a recumbent position than Filcon II 3 1 1 day .

Etafilcon A will provide rotation with subjects a recumbent position non-inferior to nelfilcon A. A margin of 5 degrees will be used.

Secondary Hypotheses:

Senofilcon A will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 monthly.

Etafilcon A for astigmatism will have significantly better monocular visual performance with subjects in a recumbent position than Filcon II 3 1 day.

Etafilcon A will have monocular visual performance with subjects in a recumbent position non-inferior nelfilcon A. A margin of 0.05 LogMAR will be used.

Conditions

  • Astigmatism
  • Myopia

Interventions

DEVICE

senofilcon A

bilateral daily use soft contact lens

DEVICE

etafilcon A

bilateral daily use soft contact lens

DEVICE

nelfilcon A

bilateral daily use soft contact lens

DEVICE

Filcon II 3

bilateral daily use soft contact lens

DEVICE

Filcon II 3

bilateral daily use soft contact lenses

Sponsors & Collaborators

  • Johnson & Johnson Vision Care, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-03-31
Completion
2013-03-31

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01579045 on ClinicalTrials.gov