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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01412983
First Posted: August 9, 2011
Last Update Posted: April 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
  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: Bausch & Lomb Test lens Device: Ciba Vision soft contact lens

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Bausch & Lomb Incorporated:

Primary Outcome Measures:
  • 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:
  • 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.


Enrollment: 100
Study Start Date: August 2011
Study Completion Date: October 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01412983     History of Changes
Other Study ID Numbers: 713E
First Submitted: August 8, 2011
First Posted: August 9, 2011
Results First Submitted: March 27, 2014
Results First Posted: April 29, 2014
Last Update Posted: April 29, 2014
Last Verified: March 2014