Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

The objective of this study is to evaluate the clinical performance of two silicone-hydrogel contact lenses.

Study Overview

• Status: Completed
• Conditions: Refractive Error
• Intervention / Treatment: Device: galyfilcon A; Device: comfilcon A

• Study Type: Interventional
• Enrollment (Actual): 97
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The subject must be at least 18 and less than or equal to 39 years of age and have a need for vision correction in both eyes.
• The subject must require a lens power between -1.00 to -6.00D and have no more than 1.00D of corneal cylinder.
• The subject, based on his/her knowledge, must be in good general health.
• The subject must be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluations.
• Subject must be a current adapted daily wearer of soft contact lenses with at least 6 months of CL wear.
• Subject must agree to wear their contact lenses in both eyes on a daily wear schedule for at least 8 hours per day every day during the study.
• Subject must be willing and able to use only the care systems and lubricating drops provided for the study during the 4 week period.
• The subject must read, indicate understanding of and sign the Informed Consent Form.

Exclusion Criteria:

• The subject is a rigid gas permeable (RGP) or daily disposable lens wearer.
• The presence of clinically significant (grade 3 or 4) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids or associated structures.
• The presence of ocular or systemic disease or need for medication which might interfere with contact lens wear or which would cause the lenses to be removed more than twice a day. (i.e., Sjogren's syndrome, type II diabetes, etc.)

• Slit lamp findings that would contraindicate contact lens wear such as:

  • pathological dry eye or associated findings
  • pterygium or corneal scars within the visual axis
  • neovascularization equal to or greater than 1mm in from the limbus
  • history of giant papillary conjunctivitis (GPC) worse than grade 2
  • anterior uveitis or iritis (past or present)
  • seborrhoeic eczema
  • seborrhoeic conjunctivitis
• A history of recurrent erosions, corneal infiltrates, corneal ulcer or fungal infections.
• A known history of corneal hypoesthesia (reduced corneal sensitivity).
• Contact lens snellen visual acuities (VA) worse than 20/30.
• Aphakia, keratoconus or a highly irregular cornea.
• Current pregnancy or lactation (to the best of the subject's knowledge)
• Any active participation in another clinical study at any time during this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: galyfilcon A/comfilcon A; galyfilcon A first, comfilcon A second	Device: galyfilcon A; galyfilcon A; Device: comfilcon A; comfilcon A
Active Comparator: comfilcon A/galyfilcon A; comfilcon A first, galyfilcon A second	Device: galyfilcon A; galyfilcon A; Device: comfilcon A; comfilcon A

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lens Comfort	>0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.	1-week, 2- weeks
Comfort Symptoms	A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable	1-week, 2-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Corneal Staining	Measured for 5 zones of the cornea (superior, nasal, central, inferior, temporal)on a 0 to 3 grade scale (NEI 0-3 scale). Grade 0 = Normal/ grade 1 = mild, superficial stippling/ grade 2 = moderate, punctate staining including superficial abrasion of the cornea/ grade 3 = severe, abrasion or corneal erosion, deep corneal abrasion or recurrent erosion.	2 weeks

Collaborators and Investigators

• Sponsor: Johnson & Johnson Vision Care, Inc.
• Collaborators: Visioncare Research Ltd.; Foresight Regulatory Strategies, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): October 1, 2007
• Study Completion (Actual): October 1, 2007

Study Registration Dates

• First Submitted: September 29, 2008
• First Submitted That Met QC Criteria: September 29, 2008
• First Posted (Estimate): September 30, 2008

Study Record Updates

• Last Update Posted (Actual): June 19, 2018
• Last Update Submitted That Met QC Criteria: June 18, 2018
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors
• Other Study ID Numbers: CR-0713