Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining
|ClinicalTrials.gov Identifier: NCT01100424|
Recruitment Status : Completed
First Posted : April 9, 2010
Last Update Posted : October 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|Corneal Staining||Device: Opti-Free RepleniSH Device: ReNu MultiPlus Device: Balafilcon A Other: Unisol 4||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||Assessment of Tear Film-Based Proteins Associated With Care Solution Induced Corneal Staining|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||September 2010|
Experimental: 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.
Device: Opti-Free RepleniSH
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.Device: ReNu MultiPlus
Commercially available contact lens solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
Other Name: RenuDevice: 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.
Other Name: PureVisionOther: Unisol 4
Commercially available non preserved sterile saline solution used for pre-soaking balafilcon A contact lenses overnight prior to lens insertion.
No Intervention: Non-lens wearers
Non-lens wearers completed one study visit and served as the control group.
- Tear Protein Expression [ Time Frame: 1 day ]
- Corneal Staining [ Time Frame: 1 day ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01100424
|United States, Texas|
|Contact Alcon Call Center for Trial Locations|
|Fort Worth, Texas, United States, 76134|
|Study Director:||Jami Kern||Alcon, Ltd.|