Non-Dispensing Evaluation of an Investigational Galyfilcon A Soft Contact Lens

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Johnson & Johnson (J&J)

Status

Completed

Conditions

Myopia

Treatments

Device: Galyfilcon A 8.7 BC (Investigational)
Device: Galyfilcon A Habitual Lens
Device: Galyfilcon A 8.3 BC (Investigational)

Study type

Interventional

Funder types

Industry
Other

Identifiers

NCT01054807
CTN# 155/2009 (Registry Identifier)
CR-0915

Details and patient eligibility

About

The purpose of this investigation is to compare the fit characteristics and vision attributes of an investigational Galyfilcon A contact lens and an approved Galyfilcon A contact lens.

Enrollment

32 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Be of legal age (i.e., at least 18 years old)
  • Sign a written informed consent
  • Have contact lens distance sphere requirement in the range -1.00D to -6.00D
  • Have spectacle astigmatism <1.25D in each eye
  • Currently wear ACUVUE® ADVANCE™ (for at least 6 months) with documentation of current prescription.
  • Have normal eyes with no evidence of abnormality or disease.

Exclusion criteria

  • Required concurrent ocular medication
  • Any systemic illness which would contra-indicate lens wear or the medical treatment of which would affect vision or successful lens wear.
  • Eye injury or surgery within eight weeks immediately prior to enrollment for this study.
  • Abnormal lacrimal secretions
  • Pre-existing ocular irritation that would preclude contact lens fitting.
  • Keratoconus or other corneal irregularity.
  • Pregnancy, lactating or planning a pregnancy at the time of enrolment.
  • Participation in any concurrent clinical trial
  • Known allergy to silver, silver ions, or silver containing compounds.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

32 participants in 6 patient groups

GalyfilconHL/Galyfilcon8.7/Galyfilcon8.3
Other group
Description:
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)
Treatment:
Device: Galyfilcon A 8.3 BC (Investigational)
Device: Galyfilcon A 8.7 BC (Investigational)
Device: Galyfilcon A Habitual Lens
Galyfilcon8.7/Galyfilcon8.3/GalyfilconHL
Other group
Description:
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Treatment:
Device: Galyfilcon A 8.3 BC (Investigational)
Device: Galyfilcon A 8.7 BC (Investigational)
Device: Galyfilcon A Habitual Lens
GalyfilconHL/Galyfilcon8.3/Galyfilcon8.7
Other group
Description:
Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)
Treatment:
Device: Galyfilcon A 8.3 BC (Investigational)
Device: Galyfilcon A 8.7 BC (Investigational)
Device: Galyfilcon A Habitual Lens
Galyfilcon 8.7/Galyfilcon HL/Galyfilcon 8.3
Other group
Description:
Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator) /Galyfilcon A 8.3 BC (Experimental)
Treatment:
Device: Galyfilcon A 8.3 BC (Investigational)
Device: Galyfilcon A 8.7 BC (Investigational)
Device: Galyfilcon A Habitual Lens
Galyfilcon8.3/GalyfilconHL/Galyfilcon8.7
Other group
Description:
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)/Galyfilcon A 8.7 BC (Experimental)
Treatment:
Device: Galyfilcon A 8.3 BC (Investigational)
Device: Galyfilcon A 8.7 BC (Investigational)
Device: Galyfilcon A Habitual Lens
Galyfilcon8.3/Galyfilcon8.7/GalyfilconHL
Other group
Description:
Galyfilcon A 8.3 BC (Experimental)/Galyfilcon A 8.7 BC (Experimental)/Galyfilcon A Habitual Lens (Active Comparator)
Treatment:
Device: Galyfilcon A 8.3 BC (Investigational)
Device: Galyfilcon A 8.7 BC (Investigational)
Device: Galyfilcon A Habitual Lens

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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