A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martine Schneider, Coopervision, Inc.
ClinicalTrials.gov Identifier:
NCT01335750
First received: October 7, 2010
Last updated: March 4, 2013
Last verified: March 2013
  Purpose

This study is a clinical comparison of the biocompatibility of several multipurpose solutions, Renu Fresh, Optifree Replenish, and ClearCare, and saline as a control solution among adapted hydrogel contact lens wearers wearing Avaira (enfilcon A) contact lenses at one research site.


Condition Intervention Phase
Corneal Staining
Other: Multipurpose Solution #1
Other: Multipurpose Solution #2
Other: Mutlipurpose Solution #3
Other: Multipurpose Solution #4
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand

Further study details as provided by Coopervision, Inc.:

Primary Outcome Measures:
  • Corneal Staining Severity [ Time Frame: Baseline, 2 Hour Period, 4 Hour Period ] [ Designated as safety issue: Yes ]
    Severity of staining was recorded for each region using a scale of 0-none to 4-patch >/=1mm. Analysis of staining was performed by averaging the scores from the five regions for each eye, then identifying the subject's worse eye at each visit. Mean total severity was calcuated from all identified eyes for each visit.

  • Corneal Staining Area [ Time Frame: Baseline, 2 Hour Period, 4 Hour Period ] [ Designated as safety issue: Yes ]
    Analysis of staining area was performed by averaging the values from the five regions for each eye and then identifying the subject's worse eye at each visit. Mean total area was calculated from all identified eyes for each visit.


Secondary Outcome Measures:
  • Subjective Comfort [ Time Frame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours ] [ Designated as safety issue: No ]
    Subjective comfort ratings 0-100 (0=causes pain, 100=excellent comfort)

  • Subjective Dryness [ Time Frame: Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours ] [ Designated as safety issue: No ]
    Subjective dryness ratings 0-100 (0=extremely dry, 100=extremely moist)


Enrollment: 32
Study Start Date: August 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Multipurpose Solution #1
B&L Renu Fresh Multipurpose Solution
Other: Multipurpose Solution #1
B&L Renu Fresh Multipurpose Solution
Other: Multipurpose Solution #2
Optifree Replenish Multipurpose Solution
Other: Mutlipurpose Solution #3
Ciba ClearCare Multipurpose Solution
Other: Multipurpose Solution #4
Saline Solution
Experimental: Multipurpose Solution #2
OptiFree Replenish Multipurpose Solution
Other: Multipurpose Solution #1
B&L Renu Fresh Multipurpose Solution
Other: Multipurpose Solution #2
Optifree Replenish Multipurpose Solution
Other: Mutlipurpose Solution #3
Ciba ClearCare Multipurpose Solution
Other: Multipurpose Solution #4
Saline Solution
Experimental: Multipurpose Solution #3
Ciba ClearCare Multipurpose Solution
Other: Multipurpose Solution #1
B&L Renu Fresh Multipurpose Solution
Other: Multipurpose Solution #2
Optifree Replenish Multipurpose Solution
Other: Mutlipurpose Solution #3
Ciba ClearCare Multipurpose Solution
Other: Multipurpose Solution #4
Saline Solution
Active Comparator: Multipurpose Solution #4
Saline Solution
Other: Multipurpose Solution #1
B&L Renu Fresh Multipurpose Solution
Other: Multipurpose Solution #2
Optifree Replenish Multipurpose Solution
Other: Mutlipurpose Solution #3
Ciba ClearCare Multipurpose Solution
Other: Multipurpose Solution #4
Saline Solution

  Eligibility

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

Inclusion Criteria:

  • Informed Consent and HIPAA document read, signed, and dated.
  • Visual acuity correctable to 20/30 (Snellen) or better in each eye at distance with hydrogel or silicone hydrogel contact lenses.
  • Successfully wearing hydrogel or silicone hydrogel contact lenses on a daily wear basis for at least two weeks prior to the study.

Exclusion Criteria:

  • History of hypersensitivity
  • Evidence or history of epithelial herpes simplex keratitis (dendritic keratitis; vaccinia, active or recent varicella, viral disease of the cornea and/or conjunctiva and/or eyelids; bacterial infection of the eye; and/or fungal disease of the eye
  • One functional eye or a monofit eye
  • Ocular conditions such as active acute blepharitis, conjunctival infections, and iritis
  • Type 2 (macropunctate) or greater corneal staining in any region in either eye as observed by slit-lamp at Visit 1 of each study period
  • Sum of the type of corneal staining greater than or equal to 4 across entire cornea in either eye as observed by slit-lamp at Visit 1 of each study period
  • Conjunctival staining covering greater than or equal to 20% in 2 or more corneal regions in either eye as observed by slit-lamp at Visit 1 of each study period
  • Conjunctival injection greater than Grade 2 (moderate-diffuse redness) in either eye as observed by slit-lamp at Visit 1 of each study period
  • Abnormal lenticular opacity in the visual axis of the lens in either eye
  • Use of concomitant topical Rx or over-the-counter (OTC) ocular medications
  • History of seasonal allergies with significant ocular side effects which may have an adverse impact on contact lens wear
  • Pregnant or lactating females
  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: NCT01335750

Locations
United States, Ohio
Erdey/Searcy Eye Group
Columbus, Ohio, United States, 43213
Sponsors and Collaborators
Martine Schneider
Investigators
Principal Investigator: Gary Andrasko, OD, MS Erdey/Searcy Eye Group
  More Information

Additional Information:
No publications provided

Responsible Party: Martine Schneider, Sr. Manager, Global Regulatory Affairs, Coopervision, Inc.
ClinicalTrials.gov Identifier: NCT01335750     History of Changes
Other Study ID Numbers: CV-09-64, Sterling IRB 3576
Study First Received: October 7, 2010
Results First Received: April 30, 2012
Last Updated: March 4, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Coopervision, Inc.:
corneal staining

Additional relevant MeSH terms:
Pharmaceutical Solutions
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014