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OpenTrials
Completed

NCT Number: NCT01309893

A Study to Evaluate 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 lenses.

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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

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

  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Be myopic and require lens correction from -0.50 D to -5.50 D in each eye.

Exclusion criteria

  • Any systemic disease affecting ocular health.
  • Using any systemic or topical medications that will affect ocular physiology or lens performance.
  • An active ocular disease, any corneal infiltrative response or are using any ocular medications.
  • Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Allergic to any component in the study care products.

Treatment and study plan

Investigational lens

Device

Lenses worn on a daily wear basis for one week

Air Optix Aqua lens

Device

Lenses worn on a daily wear basis for one week

Primary outcomes

  1. Distance High Contrast logMAR Visual Acuity at 1 Week

    Time frame: Baseline & 1 week

    Mean difference in distance high contrast logMAR over all lens VAs (visual acuity) from Baseline and 1 Week

Secondary outcomes

  1. Slit Lamp Findings ≥ Grade 2

    Time frame: 1 week

    Slit lamp findings are measured on a scale of 0-4, where 0=none, and 4=severe. The slit lamp exam is a routine procedure done to evaluate eye health and determine eligibility for clinical trial. It provides view of the different parts of the eye. During the exam, a doctor can look at the front parts of the eye, including the cornea, the lens, the iris and other parts of the anterior segment of the eye. Fluorescein dye may be used during a slit lamp examination to make it easier to detect inflammation, infections, or injured area on the cornea.

  2. Overall Comfort

    Time frame: 1 week

    Comfort measured by participant on a scale of 0-100 with 100 being the most favorable.

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
2011
Study completion
2011
First posted
Mar 7, 2011
Registry last updated
Nov 24, 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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