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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier:
NCT01412983
First received: August 8, 2011
Last updated: March 27, 2014
Last verified: March 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: Bausch & Lomb Incorporated
ClinicalTrials.gov Identifier: NCT01412983     History of Changes
Other Study ID Numbers: 713E
Study First Received: August 8, 2011
Results First Received: March 27, 2014
Last Updated: March 27, 2014
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on October 21, 2014