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
  Purpose

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.


Condition Intervention
Myopia
Device: Investigational contact lens
Device: Acuvue Oasys Contact Lens
Device: Air Optix Aqua

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Official Title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Lens

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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).


Enrollment: 120
Study Start Date: May 2010
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational contact lens
Bausch & Lomb
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.
Active Comparator: Acuvue Oasys Contact Lens
Johnson & Johnson Lens
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.
Active Comparator: Air Optix Aqua
Ciba Vision
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01131130

Locations
United States, New York
Bausch & Lomb
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Gerard Carains, MCOptom, PhD Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01131130     History of Changes
Other Study ID Numbers: 655
Study First Received: May 25, 2010
Results First Received: March 28, 2014
Last Updated: March 28, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Contact lens

ClinicalTrials.gov processed this record on October 19, 2014