Multi-Center 2-Week Clinical Evaluation of Three Silicone Hydrogel Contact Lenses

Myopia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244516
• Other study ID #: CR-201007
• Status: Completed
• Phase: N/A
• Start date: September 1, 2010
• Est. completion date: November 1, 2010

Study information

• Verified date: April 2018
• Source: Johnson & Johnson Vision Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the clinical performance of three silicone hydrogel contact lenses over a 2 week period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 540
• Est. completion date: November 1, 2010
• Est. primary completion date: November 1, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 39 Years

Eligibility

Inclusion Criteria:

• Be no less than 18 and no more than 39 years of age.

• Sign Written Informed Consent and investigator to record this on Case Report Form.

• Be willing and able to adhere to the instructions set out in the protocol.

• Be an existing successful daily wear soft contact lens wearer. For the purposes of this study this means wearing lenses for at least 6 hours per day, 5 days per week for the last month.

• No extended wear in the last 3 months.

• Subjective refraction must result in a vertex corrected spherical contact lens prescription between -1.00 and -6.00 diopters.

• Have refractive astigmatism less than or equal to 1.00 diopters (D) in both eyes.

• Achieve visual acuity of 6/9 (20/30) or better in each eye.

• Require a visual correction in both eyes (no monovision allowed).

• Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having: no amblyopia, no evidence of lid abnormality or infection (including blepharitis/meibomitis), no conjunctival abnormality or infection, no clinically significant slit lamp findings (i.e. stromal edema, vascularization, infiltrates or abnormal opacities), no other active ocular disease.

Exclusion Criteria:

• Requires concurrent ocular medication.

• Clinically significant corneal stromal haze, corneal vascularization, tarsal abnormalities, bulbar hyperemia, limbal hyperemia, or any other abnormality of the cornea that would contraindicate contact lens wear.

• Clinically significant corneal staining

• Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00 diopters).

• Has had refractive surgery.

• Has had eye injury/surgery within 8 weeks immediately prior to enrollment for this study.

• Abnormal lacrimal secretions.

• Pre-existing ocular irritation that would preclude contact lens fitting.

• Keratoconus or other corneal irregularity.

• Hard, hybrid or Rigid Gas Permeable lens wear in the previous 8 weeks.

• Any systemic illness which would contraindicate lens wear or the medical treatment of which would affect vision or successful lens wear.

• Diabetic.

• Infectious disease (e.g., hepatitis, tuberculosis) or an immunosuppressive disease [e.g., Human immunodeficiency virus (HIV)].

• History of chronic eye disease (e.g. glaucoma or Age Related Macular Degeneration).

• Pregnancy, lactating or planning a pregnancy at the time of enrollment.

• Participation in any concurrent clinical trial or in last 30 days

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• galyfilcon A, BC 8.30
galyfilcon A, BC 8.30 soft contact lens
• lotrafilcon B, BC 8.60
lotrafilcon B, BC 8.60 soft contact lens
• comfilcon A, BC 8.60
comfilcon A, BC 8.60 soft contact lens

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Vision Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Subjective Comfort	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response.	after 2 weeks of contact lens wear
Primary	Corneal Staining	Investigator evaluated corneal staining. Percent of eyes with corneal staining presence or absence is evaluated.	after 2 weeks of contact lens wear
Secondary	Overall Subjective Lens Handling	Contact Lens User Experience (CLUE)TM questionnaire: A validated patient-reported outcomes questionnaire to assess patient-experience attributes of soft, disposable contact lenses (comfort, vision, handling, and packaging) in a contact-lens wearing population in the US, ages 18-65. Scores follow a normal distribution with a population average score of 60 (SD 20), where higher scores indicate a more favorable/positive response with a range of 0 to 120. Only galyficlon A and comfilcon A were evaluated.	after 2 weeks of contact lens wear