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

NCT01873846 | Completed Results

• 1 other identifier: 817
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia

Outcome Measures

Primary Outcomes (3)

• Preference Question: How Would You Say These Contact Lenses Compare Overall With the Contact Lenses You Usually Use?

  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

  7 days

• Preference Question: These Contact Lenses Deliver Exceptional Clarity and Comfort All Day Long.

  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

  7 days

• Preference Question: These Contact Lenses Help Maintain Healthy, White Eyes.

  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

  7 days

Secondary Outcomes (2)

• Lens Performance Assessment

  2 weeks

• Any Graded Slit Lamp Finding > 2

  2 weeks

Study Arms (1)

Silicone Hydrogel Contact Lens

EXPERIMENTAL

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

Interventions

Silicone Hydrogel Contact Lens DEVICE

Silicone Hydrogel Contact Lens

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Bausch & Lomb Incorporated: lead

Study Sites (1)

Bausch & Lomb Incorporated

Madison, New Jersey, 07940, United States

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Results Point of Contact

• Title: Robert Steffen
• Organization: Bausch Health Americas, Inc

Robert.Steffen@bausch.com

Study Officials

• Johnson Varughese

  Valeant Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2013
• First Posted: June 10, 2013
• Study Start: April 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: July 1, 2013
• Last Updated: July 24, 2019
• Results First Posted: July 24, 2019

Record last verified: 2019-07

Locations

US (1)