Evaluation of a New Silicone Hydrogel Contact Lens

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01309880
First received: March 4, 2011
Last updated: February 13, 2015
Last verified: February 2015
  Purpose

The objective of this study is to determine the clinical feasibility and to evaluate the product performance of investigational contact lenses developed by Bausch + Lomb.


Condition Intervention
Myopia
Device: Test lens
Device: Air Optix Aqua

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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • Visual Acuity [ Time Frame: Dispensing & 1-week follow up ] [ Designated as safety issue: No ]
    Distance high contrast logMAR lens visual acuity (VA) between the Air Optix Aqua lens and the Test Lens at Dispensing and at 1-Week Follow-up.


Secondary Outcome Measures:
  • Slit Lamp Findings [ Time Frame: 1 week ] [ Designated as safety issue: No ]
    Measured on a scale of 0-4 where 0=none, 1=trace, 2=mild, 3=moderate, and 4=severe for edema, microcysts, corneal staining, limbal injection, bulbar injection, upper lid tarsal conjunctival abnormalities, corneal neovascularization and corneal infiltrates.

  • Comfort [ Time Frame: 1 Weeks ] [ Designated as safety issue: No ]
    At 1-Week Follow-up, participants rated lens comfort on a scale of 0 to 100, with 100 being the most favorable score.


Enrollment: 66
Study Start Date: December 2010
Study Completion Date: January 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Air Optix Aqua
Ciba Vision daily wear contact lens
Device: Air Optix Aqua
Air Optix Aqua contact lens worn on a daily wear basis
Experimental: Test Lens
Investigational silicone hydrogel contact lens
Device: Test lens
Investigational silicone hydrogel contact lens worn on a daily wear basis

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings.
  • Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.

Exclusion Criteria:

  • Have worn gas permeable (GP) contact lenses within last 30 days or polymethylmethacrylate (PMMA) lenses within last 3 months.
  • 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.
  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: NCT01309880

Locations
United States, New York
Bausch & Lomb, Incorporated
Rochester, New York, United States, 14609
Sponsors and Collaborators
Bausch & Lomb Incorporated
Investigators
Study Director: Beverly Barna Bausch & Lomb Incorporated
  More Information

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01309880     History of Changes
Other Study ID Numbers: 686E
Study First Received: March 4, 2011
Results First Received: March 31, 2014
Last Updated: February 13, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Bausch & Lomb Incorporated:
Contact lens

ClinicalTrials.gov processed this record on August 02, 2015