Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

Astigmatism Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00697190
• Other study ID #: CR-4523
• Status: Completed
• Phase: N/A
• First received: June 10, 2008
• Last updated: May 6, 2015
• Start date: May 2008
• Est. completion date: September 2008

Study information

• Verified date: May 2015
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Astigmatism

Intervention

Device:
• senofilcon A toric
silicone hydrogel contact lens for patients with astigmatism
• galyfilcon A toric
silicone hydrogel contact lens for patients with astigmatism

Locations

Country	Name	City	State
United Kingdom	Eurolens Research	Manchester

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of Conjunctival Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	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.	after 6 hours of wear	No
Primary	Assessment of Conjunctival Hyperemia in Subjects That Are Hyperopes (Farsighted)	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.	after 6 hours of wear	No
Primary	Assessment of Conjunctival Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	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.	after 6 hours of wear	No
Primary	Assessment of Limbal Hyperemia in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	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.	after 6 hours of wear	No
Primary	Assessment of Limbal Hyperemia in Subjects That Are Hyperopes (Farsighted)	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.	after 6 hours of wear	No
Primary	Assessment of Limbal Hyperemia in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	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.	after 6 hours of wear	No
Primary	Assessment of Corneal Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	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.	after 6 hours of wear	No
Primary	Assessment of Corneal Staining in Subjects That Are Hyperopes (Farsighted)	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.	after 6 hours of wear	No
Primary	Assessment of Corneal Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	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.	after 6 hours of wear	No
Primary	Assessment of Conjunctival Staining in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	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.	after 6 hours of wear	No
Primary	Assessment of Conjunctival Staining in Subjects That Are Hyperopes (Farsighted)	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.	after 6 hours of wear	No
Primary	Assessment of Conjunctival Staining in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	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.	after 6 hours of wear	No
Primary	Assessment of Papillary Conjunctivitis in Subjects That Are High Myopes (Have a High Degree of Nearsightedness)	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.	after 6 hours of wear	No
Primary	Assessment of Papillary Conjunctivitis in Subjects That Are Hyperopes (Farsighted)	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.	after 6 hours of wear	No
Primary	Assessment of Papillary Conjunctivitis in Subjects That Are Oblique Astigmats (Have an Abnormally Curved Cornea)	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.	after 6 hours of wear	No