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A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens

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ClinicalTrials.gov Identifier: NCT01412983
Recruitment Status : Completed
First Posted : August 9, 2011
Results First Posted : April 29, 2014
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated

Brief Summary:
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 or disease Intervention/treatment Phase
Myopia Device: Bausch & Lomb Test lens Device: Ciba Vision soft contact lens Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Screening
Official Title: A Study to Evaluate the Product Feasibility of a New Silicone Hydrogel Contact Lens
Study Start Date : August 2011
Actual Primary Completion Date : September 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear

Arm Intervention/treatment
Experimental: Bausch & Lomb Test Lens
Bausch + Lomb investigational soft contact lens
Device: Bausch & Lomb Test lens
Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.

Active Comparator: Ciba Vision soft contact lens
Ciba Vision Air Optix Aqua soft contact lens
Device: Ciba Vision soft contact lens
Lens to be worn on a daily wear basis for one week. Participants will be provided with Bausch + Lomb renu® fresh™ multi-purpose solution for daily rinsing, cleaning, and disinfecting of their lenses.




Primary Outcome Measures :
  1. Visual Acuity [ Time Frame: One week ]
    The mean difference in high contrast logMAR, over all lens visual acuities (VAs) between lens groups.


Secondary Outcome Measures :
  1. Overall Comfort [ Time Frame: One week ]
    The mean difference in comfort-related symptoms/complaints scores between lens groups. Rated on a scale of 0-100 with 100 being the most favorable score.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have physiologically normal anterior segments not exhibiting clinically significant biomicroscopy findings (greater than grade 1 and/or presence of infiltrates).
  • Be adapted wearers of soft contact lenses, wear a lens in each eye, and each lens must be of the same manufacture and brand.
  • Be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
  • Be myopic and require lens correction from -0.50 to -6.00 diopters (D) in each eye.

Exclusion Criteria:

  • An active ocular disease, any corneal infiltrative response or are using any ocular medications.
  • Have worn gas permeable (GP) contact lenses within last 30 days or PMMA lenses within last 3 months.
  • Any Grade 2 or greater finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Any scar or neovascularization within the central 4mm of the cornea.
  • Have had any corneal surgery.
  • Any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
  • Any systemic disease affecting ocular health.
  • Using any systemic or topical medications that will affect ocular physiology or lens performance.
  • Currently wear monovision, multifocal, or toric contact lenses.
  • Allergic to any component in the study care products.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01412983


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

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01412983     History of Changes
Other Study ID Numbers: 713E
First Posted: August 9, 2011    Key Record Dates
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014
Last Verified: March 2014