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

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01054807
• Other study ID #: CR-0915
• Secondary ID: CTN# 155/2009
• Status: Completed
• Phase: N/A
• Start date: November 1, 2009
• Est. completion date: March 1, 2010

Study information

• Verified date: June 2017
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: March 1, 2010
• Est. primary completion date: March 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Galyfilcon A Habitual Lens
Comparison of three soft contact lens designs.
• Galyfilcon A 8.7 BC (Investigational)
Comparison of three soft contact lens designs.
• Galyfilcon A 8.3 BC (Investigational)
Comparison of three soft contact lens designs

Locations

Country	Name	City	State
Australia	Coles-Brennan Pty Ltd	Hawthorn	Victoria

Sponsors (2)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	Coles-Brennan Pty Ltd

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Lens Fit Characteristics	At the screening visit, the following baseline measurements will be taken of the subject's habitual contact lenses (Control): Visual Acuity (logMar); Over-refraction with Visual Acuity; Fit acceptability (acceptable/non-acceptable)	Approximately 40 minutes of wear time
Primary	Evaluation of Inter-Changeability	In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: Ease of handling of the lenses- by Investigator; Comfort on insertion; After 30-40 minutes of settling time the following variables will be collected: Subjective comfort after settling; Visual Acuity (logMar); Corneal coverage (Y/N); Post-blink movement (mm); Version Lag (mm); Tightness on push-up (0-100 scale); Overall fit acceptance (0-5 scale)	Approximately 40 minutes of wear time
Primary	Determination of fit or Vision Differences	In a bilateral fashion, the subject will wear Test/Control lens according to a pre-designed randomization schedule. Immediately upon insertion, the following variables will be assessed: Ease of handling of the lenses- by Investigator; Comfort on insertion; After 30-40 minutes of settling time the following variables will be collected: Subjective comfort after settling; Visual Acuity (logMar); Corneal coverage (Y/N); Post-blink movement (mm); Version Lag (mm); Tightness on push-up (0-100 scale); Overall fit acceptance (0-5 scale)	Approximately 40 minutes of wear time