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OpenTrials
Completed

NCT Number: NCT01131130

Feasibility of a New Silicone Hydrogel Lens

The objective of this study is to determine the product feasibility of the investigational contact lens (Test) when compared to the currently marketed Acuvue Oasys contact lens (Control) and the Air Optix Aqua contact lens (Control) when worn by adapted wearers of soft 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: No

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

Inclusion criteria

  • Participants must have clear central corneas and be free of any anterior segment disorders.
  • Participants 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.
  • Participants must be myopic and require lens correction from -0.75 D to - 4.75D in each eye.

Exclusion criteria

  • Participants 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.
  • Participants with any systemic disease affecting ocular health.
  • Participants using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
  • Participants with an active ocular disease or are using any ocular medication.
  • Participants who have had any corneal surgery (eg, refractive surgery).
  • Participants who are allergic to any component in the study care products.

Treatment and study plan

Investigational Contact Lens

Device

After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

Acuvue Oasys Contact Lens

Device

After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

Air Optix Aqua

Device

After one week of wearing the first lens type, the participants will crossover to the second lens type for one week, and then crossover to the third lens type.

Primary outcomes

  1. Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens

    Time frame: 7 days

    Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.

  2. Comfort Throughout the Day - Test Lens vs. Acuvue Oasys

    Time frame: 7 days

    Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.

Secondary outcomes

  1. Lens Wettability, Test Lens vs. Acuvue Oasys

    Time frame: 7 days

    Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).

  2. Lens Wettability, Test Lens vs. Air Optix Aqua

    Time frame: 7 days

    Lens wettability was assessed at each visit as Grade 4 - 0, with 4=optimal (100% of anterior surface wettable) and 0=severe (Presence of one or more non-wetting areas > 0.5 mm in size).

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 Lens

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 26, 2010
Registry last updated
Apr 30, 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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