Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

Not Applicable

Completed

• Conditions: Astigmatism
• Interventions: Device: senofilcon A toric; Device: galyfilcon A toric

• Registration Number: NCT00697190
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

This study will evaluate the fitting characteristics and physiological response of two toric lenses manufactured by Vistakon.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-06-10
• Study First Submitted QC: 2008-06-12
• Study First Posted: 2008-06-13
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Results First Submitted: 2010-09-09
• Results First Submitted QC: 2010-09-09
• Results First Posted: 2010-10-01
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-06
• Last Update Posted: 2015-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

Inclusion Criteria

• Able to wear study lenses in parameters available.
• At least 18
• understand and sign informed consent
• willing to follow the protocol
• achieve at least 6/9 Visual Acuity (VA), both eyes (OU) with study lenses
• hyperopes: +2.00 to +4.00 with -0.75 D cylinder around 180, high myopes: -6.00 to -8.00 with -1.25 D cylinder around 180
• oblique axis: -2.00 to -4.00 with -0.75 D cyl around 45 or 135, have worn Soft Contact Lenses's within last 6 months

Exclusion Criteria

• Any ocular or systemic disorder which may contraindicate Contact Lens (CL) 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
senofilcon A/galyfilcon A	galyfilcon A toric	senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.
galyfilcon A/senofilcon A	senofilcon A toric	galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.
senofilcon A/galyfilcon A	senofilcon A toric	senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.
galyfilcon A/senofilcon A	galyfilcon A toric	galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.

Primary Outcome Measures

Name	Time	Method
Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	after 6 hours of wear	Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)	after 6 hours of wear	Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)	after 6 hours of wear	Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)	after 6 hours of wear	Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)	after 6 hours of wear	Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	after 6 hours of wear	Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	after 6 hours of wear	Conjunctival hyperemia measures the redness across the white of the eye. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)	after 6 hours of wear	Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	after 6 hours of wear	Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	after 6 hours of wear	Limbal hyperemia measures the redness around the edge of the cornea. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	after 6 hours of wear	Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	after 6 hours of wear	Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	after 6 hours of wear	Corneal staining measures changes to the surface of the cornea, as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	after 6 hours of wear	Conjunctival staining measures the changes to the conjunctival surface as evaluated by the degree of staining with sodium fluorescein solution. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.
Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	after 6 hours of wear	Papillary conjunctivitis measures the changes to the conjunctival surface on the underside of the upper eyelid. The investigator used a grading scale of 0=none, 1=slight, 2=moderate, 3=severe.

Trial Locations

Locations (1)

Eurolens Research; 🇬🇧 Manchester, United Kingdom