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A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens

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: NCT01873846
Recruitment Status : Completed
First Posted : June 10, 2013
Results First Posted : July 24, 2019
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
The objective of this study is to evaluate the product performance of a new silicone hydrogel soft contact lens when worn by current soft contact lens wearers on a daily wear basis.

Condition or disease Intervention/treatment Phase
Myopia Device: Silicone Hydrogel Contact Lens Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 400 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Study to Evaluate the Product Performance of a New Silicone Hydrogel Contact Lens
Study Start Date : April 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Silicone Hydrogel Contact Lens
Contact lenses to be worn in each eye on a daily wear basis for 2 weeks. Participants will be provided with Bausch + Lomb Biotrue® multi-purpose solution and contact lens cases for daily rinsing, cleaning, disinfecting, and storing their lenses.
Device: Silicone Hydrogel Contact Lens



Primary Outcome Measures :
  1. Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use? [ Time Frame: 7 days ]
    Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to answer the following question: "How would you say these contact lenses compare overall with the contact lenses you usually use?" Prefer study lenses Prefer usual lenses About the same as usual lenses

  2. Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long. [ Time Frame: 7 days ]
    Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses deliver exceptional clarity and comfort all day long." Prefer study lenses Prefer usual lenses About the same as usual lenses

  3. Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes. [ Time Frame: 7 days ]
    Participants will respond to a survey regarding their experience wearing the Test Lens after 7 days of wear. Participants were asked to assess the following statement with respect to their usual contact lenses: "These contact lenses help maintain healthy, white eyes." Prefer study lenses Prefer usual lenses About the same as usual lenses


Secondary Outcome Measures :
  1. Lens Performance Assessment [ Time Frame: 2 weeks ]
    High Contrast Distance logMAR Lens VA Change From Baseline to Week 2.

  2. Any Graded Slit Lamp Finding > 2 [ Time Frame: 2 weeks ]
    Slit lamp findings for each eye, including epithelial edema, epithelial microcysts, corneal staining, limbal and bulbar injections, upper lid tarsal conjunctival abnormalities, corneal neovascularization, and corneal infiltrates, were graded for severity on a scale from 0 (No Finding) to 4 (Severe Finding). Corneal staining grades were computed as the maximum grade over grades taken within each of five different eye locations (central, inferior, nasal, superior, and temporal). Eyes with multiple visits are counted once for the highest grade.



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye
  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
  • Subjects must be myopic and require lens correction from -0.25 D to -6.00 D in each eye.
  • Subject must wear their current lenses for a minimum of 12 hours per day at least four days per week.
  • Subjects must spend at least 3 hours each workday using a computer or electronic device (ie, smartphones, tablets, eReaders).
  • Subjects must habitually wear soft contact lens.
  • Subject must have no active ocular disease or allergic conjunctivitis.
  • Subject must not be using any topical ocular medications.
  • Subjects must be bothered (occasionally or frequently) by blurriness or fluctuations in vision with their current contact lenses.
  • Subjects must habitually use a lens care product for cleaning, disinfection, and storage.

Exclusion Criteria:

  • Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
  • Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
  • Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Subjects with an active ocular disease or who are using any ocular medication.
  • Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
  • Subjects who are presbyopic or currently wear monovision, multifocal, or toric contact lenses.
  • Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
  • Subjects with anisometropia (spherical equivalent) of 2.00 D or greater in either eye.
  • Subjects with any Grade 2 or greater finding during the slit lamp examination.
  • Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Subjects with any scar or neovascularization within the central 4 mm of the cornea.
  • Subjects who are aphakic.
  • Subjects who are amblyopic.
  • Subjects who have had any corneal surgery (eg, refractive surgery).
  • Subjects who are allergic to any component in the study care products.
  • Subjects who are bothered by blurriness or fluctuations in vision due to itchy eyes, something on or under the lens, allergies, or cigarette smoke.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01873846


Locations
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United States, New Jersey
Bausch & Lomb Incorporated
Madison, New Jersey, United States, 07940
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
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Study Director: Johnson Varughese Valeant Pharmaceuticals

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Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01873846     History of Changes
Other Study ID Numbers: 817
First Posted: June 10, 2013    Key Record Dates
Results First Posted: July 24, 2019
Last Update Posted: July 24, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Myopia
Refractive Errors
Eye Diseases