Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining
NCT ID: NCT01100424
Last Updated: 2012-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
60 participants
INTERVENTIONAL
2010-03-31
2010-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
SUPPORTIVE_CARE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Contact lens wearers
Contact lens wearers experienced three currently available contact lens/contact lens care combinations in randomized order: balafilcon A + Optifree RepleniSH, balafilcon A + ReNu MultiPlus, and balafilcon A + Unisol 4 saline.
Opti-Free RepleniSH
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
ReNu MultiPlus
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Balafilcon A
Commercially available silicone hydrogel contact lenses removed from blister pack and soaked overnight in Opti-Free Replenish, ReNu MultiPlus, or Unisol 4, then applied to the eye and worn for 2 hours.
Unisol 4
Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Non-lens wearers
Non-lens wearers completed one study visit and served as the control group.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Opti-Free RepleniSH
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
ReNu MultiPlus
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Balafilcon A
Commercially available silicone hydrogel contact lenses removed from blister pack and soaked overnight in Opti-Free Replenish, ReNu MultiPlus, or Unisol 4, then applied to the eye and worn for 2 hours.
Unisol 4
Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Normal eyes.
* Currently not wearing contact lenses and has not worn contact lenses for the previous 6 months.
* Free of dry eye using the Ocular Surface Disease Index (Schiffman et al).
For contact lens wearers:
* Currently wearing soft contact lenses.
* Free of dry eye during lens wear using the Contact Lens Dry Eye Questionnaire Short-Form (Nichols et al, Cornea, 2002).
* Reports a contact lens wearing time of at least 12 hours per day, 7 days per week, daily wear basis (not overnight wear).
* Reports only occasional use of contact lens rewetting drops or artificial tears.
Exclusion Criteria
* Pregnant.
* Participating in another research study.
* Exhibiting staining with fluorescein in more than 5% of the total cornea (graded by "extent" of staining across 5 regions).
18 Years
35 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alcon Research
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jami Kern
Role: STUDY_DIRECTOR
Alcon, Ltd.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Contact Alcon Call Center for Trial Locations
Fort Worth, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SMA-09-20
Identifier Type: -
Identifier Source: org_study_id