Clinical Evaluation Of Two Daily Disposable Contact Lenses And A Monthly Replacement Lens

Not Applicable

Completed

• Conditions: Myopia
• Interventions: Device: narafilcon B contact lens; Device: lotrafilcon B contact lens; Device: nelfilcon A contact lens

• Registration Number: NCT01151371
• Lead Sponsor: Johnson & Johnson Vision Care, Inc.

Brief Summary

The objective of the study is to compare the clinical performance of silicone hydrogel daily disposable contact lenses, conventional hydrogel daily disposable contact lenses and silicone hydrogel monthly replacement contact lenses.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-01
• Study First Submitted: 2010-03-24
• Primary Completion: 2010-04-01
• Study Completion: 2010-04-01
• Study First Submitted QC: 2010-06-25
• Study First Posted: 2010-06-28
• Results First Submitted: 2011-09-15
• Results First Submitted QC: 2011-11-14
• Results First Posted: 2011-12-19
• Status Verified: 2017-08
• Last Update Submitted: 2018-06-18
• Last Update Posted: 2018-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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 (See separate document).

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

• Own a cell phone and be willing to receive text messages during the day.

• Be an existing successful daily wear soft contact lens. 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 vertexed spherical contact lens prescription between -1.00 and -6.00D.

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

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

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

• Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).

• 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 (Grade 3 or 4) 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 (Grade 3 in more than one corneal region per eye).
• Requires presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).
• Has had refractive surgery.
• Has had eye injury/surgery within 8 weeks immediately prior to enrolment for this study.
• Abnormal lacrimal secretions.
• Pre-existing ocular irritation that would preclude contact lens fitting.
• Keratoconus or other corneal irregularity.
• PMMA(polymethyl methacrylate), hybrid or RGP(rigid gas permeable) lens wear in the previous 8 weeks.

Does not require presbyopic correction (i.e. Not using any presbyopic correction and measured add power of less than +1.00D).

• 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., HIV (Human immunodeficiency virus)).
• History of chronic eye disease (e.g. glaucoma or ARMD (age related macular degeneration)).
• Pregnancy, lactating or planning a pregnancy at the time of enrolment.
• Participation in any concurrent clinical trial or in last 30 days.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
narafilcon B daily disposable 4 weeks	narafilcon B contact lens	narafilcon B soft contact lenses worn daily on a daily disposable/replacement schedule, for 4 weeks
lotrafilcon B daily wear, monthly replacement, 4-weeks	lotrafilcon B contact lens	lotrafilcon B soft contact lenses worn daily on a 1-month replacement schedule, for 4 weeks
nelfilcon A daily disponsable 1 week	nelfilcon A contact lens	nelfilcon A soft contact lenses worn daily on a daily disposable/replacement schedule, for 1 week

Primary Outcome Measures

Name	Time	Method
Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B	After 4 Weeks	Redness scale of 0 to 4, where 0=None, and 4=Severe.
Overall Comfort Narafilcon B v. Nelfilcon A	After 1 week	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.
Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A	After 1 Week	Redness scale of 0 to 4, where 0=None, 4=Severe redness
Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B	After 4 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A	After 1 Week	Standard scale of 0 to 3 where 0=None, 3=Severe staining
Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A	After 1 Week	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.
Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A	After 1 Week	Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort
Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A	After 1 Week	Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort.
Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B	After 4 Weeks	Scale of 0 to 3, where 0=none and 3=severe staining.
Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B	After 4 Weeks	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.
Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B	After 4 Weeks	Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort
Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B	After 4 Weeks	Comfort immediately after the lens is put on the eye. Scale of 1 to 5, where 1=poor comfort, 5=excellent comfort.