Clinical Performance of Atypical Contact Lens Powers on Subjects With Astigmatism

NCT00697190 | Completed Results

• 1 other identifier: CR-4523
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Astigmatism

Outcome Measures

Primary Outcomes (15)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

senofilcon A/galyfilcon A

ACTIVE COMPARATOR

senofilcon A silicone hydrogel toric contact lenses will be worn first. galyfilcon A silicone hydrogel toric contact lenses will be worn second.

Device: senofilcon A toric; Device: galyfilcon A toric

galyfilcon A/senofilcon A

ACTIVE COMPARATOR

galyfilcon A silicone hydrogel toric contact lenses worn first. senofilcon A silicone hydrogel toric contact lenses worn second.

Device: senofilcon A toric; Device: galyfilcon A toric

Interventions

senofilcon A toric DEVICE

silicone hydrogel contact lens for patients with astigmatism

Also known as: Acuvue Oasys for Astigmatism

galyfilcon A/senofilcon A; senofilcon A/galyfilcon A

galyfilcon A toric DEVICE

silicone hydrogel contact lens for patients with astigmatism

Also known as: Acuvue Advance for Astigmatism

galyfilcon A/senofilcon A; senofilcon A/galyfilcon A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Vision Care, Inc.: lead

Study Sites (1)

Eurolens Research

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Astigmatism

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: John Buch OD
• Organization: Vistakon

904-443-1707

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2008
• First Posted: June 13, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 22, 2015
• Results First Posted: October 1, 2010

Record last verified: 2015-05

Locations

GB (1)