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OpenTrials
Completed

NCT Number: NCT01151371

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

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.

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Key information

Age range

18 year–39 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brea, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Narafilcon B Contact Lens

Device

Silicone Hydrogel Daily Disposable Contact Lenses

Nelfilcon A contact lens

Device

Conventional Hydrogel Daily Disposable Contact Lenses

Lotrafilcon B contact lens

Device

Silicone Hydrogel Monthly Replacement Contact Lenses

Primary outcomes

  1. Overall Comfort Narafilcon B v. Nelfilcon A

    Time frame: 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.

  2. Signs of Limbal Hyperemia Narafilcon B v. Nelfilcon A

    Time frame: After 1 Week

    Redness scale of 0 to 4, where 0=None, 4=Severe redness

  3. Subjective Rating of Overall Comfort Narafilcon B v. Lotrafilcon B

    Time frame: 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.

  4. Signs of Limbal Hyperemia Narafilcon B v. Lotrafilcon B

    Time frame: After 4 Weeks

    Redness scale of 0 to 4, where 0=None, and 4=Severe.

Secondary outcomes

  1. Signs of Inferior Corneal Staining Narafilcon B v. Nelfilcon A

    Time frame: After 1 Week

    Standard scale of 0 to 3 where 0=None, 3=Severe staining

  2. Subjective Rating of Overall Ease of Lens Handling Narafilcon B v Nelfilcon A

    Time frame: 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.

  3. Subjective Rating of End of Day Comfort Narafilcon B v. Nelfilcon A

    Time frame: After 1 Week

    Scale of 1 to 5, where 1=Poor comfort and 5=Excellent comfort

  4. Subjective Rating of Initial Comfort Narafilcon B v. Nelfilcon A

    Time frame: 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.

  5. Signs of Inferior Corneal Staining Narafilcon B v. Lotrafilcon B

    Time frame: After 4 Weeks

    Scale of 0 to 3, where 0=none and 3=severe staining.

  6. Subjective Rating of Overall Ease of Lens Handling Narafilcon B v. Lotrafilcon B

    Time frame: 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.

  7. Subjective Rating of End of Day Comfort Narafilcon B v. Lotrafilcon B

    Time frame: After 4 Weeks

    Scale of 1 to 5, where 1=poor comfort and 5=excellent comfort

  8. Subjective Rating of Initial Comfort Narafilcon B v. Lotrafilcon B

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Vision Care, Inc.

Industry

Collaborators

  • Visioncare Research Ltd.

Registry information

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Jun 28, 2010
Registry last updated
Jun 19, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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