A Clinical Comparison of Marketed Lens Care Solutions With Avaira Lens Brand
1 other identifier
interventional
32
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2010
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 7, 2010
CompletedFirst Posted
Study publicly available on registry
April 14, 2011
CompletedResults Posted
Study results publicly available
March 5, 2013
CompletedJuly 28, 2020
July 1, 2020
1 month
October 7, 2010
April 30, 2012
July 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Corneal Staining Severity
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.
Baseline, 2 Hour Period, 4 Hour Period
Corneal Staining Area
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.
Baseline, 2 Hour Period, 4 Hour Period
Secondary Outcomes (2)
Subjective Comfort
Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Subjective Dryness
Visit 1: Baseline; Visit 2: 2 hours, Visit 3: 4 hours
Study Arms (4)
Multipurpose Solution #1
EXPERIMENTALB\&L Renu Fresh Multipurpose Solution
Multipurpose Solution #2
EXPERIMENTALOptiFree Replenish Multipurpose Solution
Multipurpose Solution #3
EXPERIMENTALCiba ClearCare Multipurpose Solution
Multipurpose Solution #4
ACTIVE COMPARATORSaline Solution
Interventions
B\&L Renu Fresh Multipurpose Solution
Optifree Replenish Multipurpose Solution
Ciba ClearCare Multipurpose Solution
Saline Solution
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Erdey/Searcy Eye Group
Columbus, Ohio, 43213, United States
Related Links
Results Point of Contact
- Title
- Dr. Gary Andrasko, MS
- Organization
- Erdy/Searcy Group
Study Officials
- PRINCIPAL INVESTIGATOR
Gary Andrasko, OD, MS
Erdey/Searcy Eye Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2010
First Posted
April 14, 2011
Study Start
August 1, 2010
Primary Completion
September 1, 2010
Study Completion
September 1, 2010
Last Updated
July 28, 2020
Results First Posted
March 5, 2013
Record last verified: 2020-07