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Clinical Comparison of Two Silicone-Hydrogel Contact Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762385
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : February 10, 2010
Last Update Posted : June 19, 2018
Sponsor:
Collaborators:
Foresight Regulatory Strategies, Inc.
Visioncare Research Ltd.
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.

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

Condition or disease Intervention/treatment Phase
Refractive Error Device: galyfilcon A Device: comfilcon A Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 97 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : August 2007
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Lens Comfort [ Time Frame: 1-week, 2- weeks ]
    >0 = comfortable, <0 = uncomfortable; a weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes.

  2. Comfort Symptoms [ Time Frame: 1-week, 2-weeks ]
    A weighted combined score calculated from individual comfort-related questions was used to derive comfort outcomes. >0 = comfortable, <0 = uncomfortable


Secondary Outcome Measures :
  1. Overall Corneal Staining [ Time Frame: 2 weeks ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
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Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00762385    
Other Study ID Numbers: CR-0713
First Posted: September 30, 2008    Key Record Dates
Results First Posted: February 10, 2010
Last Update Posted: June 19, 2018
Last Verified: May 2015
Additional relevant MeSH terms:
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Refractive Errors
Eye Diseases