Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

Astigmatism Clinical Trial

Official title:

Comparison of Senofilcon A Toric Lenses to Balafilcon A Toric Lenses Over Extended Wear Period

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762502
• Other study ID #: CR-4498
• Status: Completed
• Phase: N/A
• Start date: June 2007
• Est. completion date: January 2008

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

To evaluate two toric contact lenses on the ocular physiology of existing contact lens wearers when used in an extended wear modality of days/six nights.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: January 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Able to wear study lenses in parameters available

• Non-presbyopes between the ages of 18-45

• Understand and sign informed consent

• Willing to follow the protocol

• Achieve at least 20/30 (6/9) visual acuity (VA) in right eye (OD) and left eye (OS) with study lenses

• Myopia -0.75 to -6.25, cylinder -0.75 to -1.50 diopters (D) (axis 90 +/- 15, 180 +/- 15) or -1.75 D (axis 90 +/- 10, 180 +/- 10)

• Adapted soft contact lens wearer

• Swims no more than once a week

• Has a wearable pair of spectacles.

Exclusion Criteria:

• Any ocular or systemic disorder which may contraindicate contact lens wear

• Any topical ocular medication

• Aphakic

• Corneal refractive surgery

• Corneal distortion from hard CL wear or keratoconus

• Pregnant or lactating

• Grade 2 or worse slit lamp signs

• Infectious disease

• Previous clinical study within 2 weeks

• Don't agree to participate

• Polymethyl methacrylate (PMMA) or rigid gas-permeable (RGP) lens wear in last 8 weeks

• Previous adverse effects that contraindicate extended lens wear.

• Self-reported symptoms of itchiness or scratchiness with habitual lenses.

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• senofilcon A toric contact lens
soft contact lens
• balafilcon A toric contact lens
soft contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Corneal Staining	Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.	at 3 months of lens wear (period 1)
Primary	Limbal Redness	Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.	at 3 months of lens wear (period 1)
Primary	Bulbar Redness	Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.	at 3 months of lens wear (period 1)
Primary	Tarsal Roughness	Scale of 0 to 4; 0=None, 1=Trace, 2=Mild, 3=Moderate, 4=Severe. The subjects were assigned to senofilcon A toric/balafilcon A toric contralaterally or senofilcon A or balafilcon A lenses bilaterally.	at 3 months of lens wear (period 1)