Feasibility of a New Silicone Hydrogel Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01131130
First received: May 25, 2010
Last updated: March 28, 2014
Last verified: March 2014

May 25, 2010
March 28, 2014
May 2010
June 2010   (final data collection date for primary outcome measure)
  • Comfort Throughout the Day - Test Lens vs. Air Optix Aqua Lens [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
  • Comfort Throughout the Day - Test Lens vs. Acuvue Oasys [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    Subjective measurements of lens comfort were rated on a scale from 0 to 100, where 100 was the most favorable.
Not Provided
Complete list of historical versions of study NCT01131130 on ClinicalTrials.gov Archive Site
  • Lens Wettability, Test Lens vs. Acuvue Oasys [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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).
  • Lens Wettability, Test Lens vs. Air Optix Aqua [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    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).
Not Provided
Not Provided
Not Provided
 
Feasibility of a New Silicone Hydrogel Lens
A Study to Evaluate the Product 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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Myopia
  • Device: Investigational contact lens
    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.
  • Device: Acuvue Oasys Contact Lens
    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.
  • Device: Air Optix Aqua
    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.
  • Experimental: Investigational contact lens
    Bausch & Lomb
    Intervention: Device: Investigational contact lens
  • Active Comparator: Acuvue Oasys Contact Lens
    Johnson & Johnson Lens
    Intervention: Device: Acuvue Oasys Contact Lens
  • Active Comparator: Air Optix Aqua
    Ciba Vision
    Intervention: Device: Air Optix Aqua
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
June 2010
June 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01131130
655
No
Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
Not Provided
Study Director: Gerard Carains, MCOptom, PhD Bausch & Lomb Incorporated
Bausch & Lomb Incorporated
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP