Vistakon Investigational Multi-purpose Contact Lens Care Solution.
1 other identifier
interventional
315
1 country
14
Brief Summary
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2009
Shorter than P25 for not_applicable
14 active sites
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
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
January 22, 2010
CompletedFirst Posted
Study publicly available on registry
January 25, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
January 24, 2017
CompletedJune 19, 2018
August 1, 2017
6 months
January 22, 2010
August 10, 2016
June 18, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Slit Lamp Findings (SLF)
Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported.
Up to 3 months Post Lens Wear
Distance Visual Acuity (LogMAR)
Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported.
Up to 3 Months Post Lens Wear
Study Arms (2)
Experimental Multi-Purpose Solution
EXPERIMENTALcontact lens care solution
ReNu MultiPlus Multi-Purpose Solution
ACTIVE COMPARATORcontact lens care solution
Interventions
contact lens care solution
contact lens care solution
Eligibility Criteria
You may qualify if:
- must be an adapted contact lens wearer
- best corrected distance visual acuity must be 20/25 or better in each eye
- must be wearing their habitual lenses on a daily wear basis
- must be willing to refrain from swimming during the study
You may not qualify if:
- any systemic diseases that may interfere with contact lens wear
- any clinically significant ocular disease
- any ocular infection
- use of certain medications
- any grade 2 or greater slit lamp findings
- any know sensitivity to marketed contact lens care solutions
- currently pregnant or lactating
- monovision corrected
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Unknown Facility
Mission Viejo, California, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Tallahassee, Florida, United States
Unknown Facility
Bloomington, Illinois, United States
Unknown Facility
Pittsburg, Kansas, United States
Unknown Facility
Jamestown, New York, United States
Unknown Facility
Vestal, New York, United States
Unknown Facility
Athens, Ohio, United States
Unknown Facility
Moon Township, Pennsylvania, United States
Unknown Facility
State College, Pennsylvania, United States
Unknown Facility
Amarillo, Texas, United States
Unknown Facility
Katy, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Charlottesville, Virginia, United States
Results Point of Contact
- Title
- Kristy Canavan, O.D.- PRINCIPAL RESEARCH OPTOMETRIST, Clin Ops
- Organization
- Johson & Johnson Vision Care Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2010
First Posted
January 25, 2010
Study Start
November 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
June 19, 2018
Results First Posted
January 24, 2017
Record last verified: 2017-08