Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

Refractive Error Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00762385
• Other study ID #: CR-0713
• Status: Completed
• Phase: N/A
• Start date: August 2007
• Est. completion date: October 2007

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

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.

Related Conditions & MeSH terms

• Refractive Error
• Refractive Errors

Intervention

Device:
• galyfilcon A
galyfilcon A
• comfilcon A
comfilcon A

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.	Foresight Regulatory Strategies, Inc., Visioncare Research Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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