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OpenTrials
Completed

NCT Number: NCT01309100

Product Feasibility of a New Silicone Hydrogel Contact Lens

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lens.

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Key information

Conditions

Myopia Eye Diseases Refractive Errors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bausch & Lomb Incorporated

Rochester, New York, 14609, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects must have clear central corneas and be free of any anterior segment disorders.
  • Subjects must be adapted wearers of soft contact lenses, 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

Exclusion criteria

  • Subjects with any systemic disease affecting ocular health.
  • 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 are using any ocular medication.
  • Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.

Treatment and study plan

Investigational lens

Device

Bausch & Lomb investigational silicone hydrogel lens on a daily wear basis for 1 week.

Acuvue Oasys Lens

Device

Johnson & Johnson Acuvue Oasys contact lens on a daily wear basis for 1 week.

Air Optix Aqua lens

Device

Ciba Vision Air Optix Aqua contact lens on a daily wear basis for 1 week.

Primary outcomes

  1. Visual Acuity (Investigational vs Air Optix Aqua Lens)

    Time frame: 1 week

    The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens (RD2117-01) and the Air Optix Aqua control lens.

  2. Visual Acuity (Investigational vs Acuvue Oasys Lens)

    Time frame: 1 week

    The mean difference in distance high contrast logMAR visual acuity(VA) between the investigational lens(RD2117-01) and the Acuvue Oasys control lens.

Secondary outcomes

  1. Comfort Throughout the Day (Investigational vs Acuvue Oasys Lens)

    Time frame: 1 week

    The mean differences in comfort between the investigational lens (RD2117-01) and the Acuvue Oasys control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.

  2. Comfort Throughout the Day (Investigational vs Air Optix Aqua Lens)

    Time frame: 1 week

    The mean differences in comfort between the investigational lens(RD2117-01) and the Air Optix Aqua control lens. Comfort was measured on a scale of 0 to 100, with 100 being the most favorable score.

Sponsors and collaborators

Lead sponsor

Bausch & Lomb Incorporated

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2011
First posted
Mar 4, 2011
Registry last updated
Apr 29, 2014

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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