Evaluation of an Investigational Multi-Purpose Solution (MPS)
1 other identifier
interventional
270
1 country
9
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of an investigational multi-purpose contact lens solution.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Feb 2009
Shorter than P25 for phase_3
9 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
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
July 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2009
CompletedFirst Posted
Study publicly available on registry
August 18, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedResults Posted
Study results publicly available
January 7, 2014
CompletedJanuary 7, 2014
December 1, 2013
6 months
July 27, 2009
May 16, 2013
December 6, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Lens Cleanliness as Measured by Light Reflectance
Lens cleanliness was assessed by total light reflectance, which is a computerized quantitative assessment conducted in a laboratory. The amount of light that scattered off the lens surface in a light field and was assessed using a light reflectance score that ranged from 0 (maximum lens cleanliness; clean/clear) to100 (minimum lens cleanliness; dirty/opaque).
Day 30
Secondary Outcomes (1)
Number of Subjects With no Corneal Staining
Day 180
Study Arms (2)
Investigational MPS
EXPERIMENTALInvestigational multipurpose disinfecting solution (study MPS)
Predicate MPS
ACTIVE COMPARATOROpti-Free RepleniSH multipurpose disinfecting solution (predicate MPS)
Interventions
Eligibility Criteria
You may qualify if:
- Have successfully worn hydrogel contact lenses of the same material to be worn during the study
- Have normal eyes (with the exception of unaided visual acuity)
- Have successfully used a multi-purpose contact lens care solution
- Have acceptable visual acuity and lens wearing comfort at time of enrollment
You may not qualify if:
- Concurrently enrolled another clinical trial
- Have a known sensitivity to any study product ingredient(s)
- Have a condition that may put them at significant risk
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (9)
Complete Family Vision Center
San Diego, California, 92123, United States
Eye Care Associates of Hawaii
Waipahu, Hawaii, 96797, United States
Insight Eyecare
Warrensburg, Missouri, 64093, United States
Drs. Quinn, Quinn & Associates
Athens, Ohio, 45701, United States
Western Reserve Vision Care
Beachwood, Ohio, 44122, United States
Central Ohio Eyecare
Columbus, Ohio, 43202, United States
Northeastern Eye Institute
Scranton, Pennsylvania, 18503, United States
West Bay Eye Associates
Warwick, Rhode Island, 02888, United States
Ziegler Leffingwell Eyecare
West Allis, Wisconsin, 53227, United States
Results Point of Contact
- Title
- Eugenia Thomas, O.D.
- Organization
- Abbott Medical Optics
Study Officials
- STUDY CHAIR
Nicholas Tarantino, OD
Abbott Medical Optics
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2009
First Posted
August 18, 2009
Study Start
February 1, 2009
Primary Completion
August 1, 2009
Study Completion
November 1, 2009
Last Updated
January 7, 2014
Results First Posted
January 7, 2014
Record last verified: 2013-12