Changes in the Tear Film With Scleral Contact Lens Wear for Keratoconic Eyes
Protease and Cytokine Composition in Post Lens Tear Reservoir of Scleral Lenses for Keratoconic Eyes
1 other identifier
interventional
13
0 countries
N/A
Brief Summary
The purpose of this study is to investigate changes in the level of inflammatory mediators in the tear film of scleral contact lens wearers in a keratoconic population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2016
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
First Submitted
Initial submission to the registry
June 16, 2016
CompletedFirst Posted
Study publicly available on registry
June 21, 2016
CompletedStudy Start
First participant enrolled
August 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2018
CompletedJune 27, 2019
June 1, 2019
1.5 years
June 16, 2016
June 25, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tear Protein
To measure the level proteases and cytokines in each of the samples using Meso Scale Discovery system (MSD-ECL).
2 weeks of lens wear with daily schedule of 6-8 hours.
Secondary Outcomes (3)
Comfort
2 weeks of lens wear with daily schedule of 6-8 hours.
Bulbar and limbal hyperemia
2 weeks of lens wear with daily schedule of 6-8 hours.
Corneal thickness
2 weeks of lens wear with daily schedule of 6-8 hours.
Study Arms (2)
ZenLens with Low limbal clearance
ACTIVE COMPARATORScleral contact lens designed to provide approximately 25 microns of limbal clearance.
ZenLens with High limbal clearance
ACTIVE COMPARATORScleral contact lens designed to provide approximately 80 microns of limbal clearance.
Interventions
The ZenLens™ semi-scleral lenses are manufactured by Alden Optic Laboratories Inc., Lancaster, NY. They will be made in Boston XO material.
Eligibility Criteria
You may qualify if:
- Had been diagnosed with keratoconus in at least one eye.
- Is at least 18 years of age and has full legal capacity to volunteer.
- Has read and understood the information consent letter.
- Is willing and able to follow instructions and maintain the appointment schedule.
You may not qualify if:
- Is using any topical medications that will affect ocular health.
- Has any ocular pathology or severe insufficiency of lacrimal secretion (severe dry eyes) that would affect the wearing of contact lenses.
- Has persistent, clinically significant corneal or conjunctival staining using sodium fluorescein dye.
- Has any clinically significant lid or conjunctival abnormalities and active neovascularization.
- Is aphakic.
- Has undergone any corneal surgery.
- Is participating in any other type of eye related clinical or research study.
- Has any known allergies or sensitivity to the diagnostic pharmaceuticals or products, such as fluorescein, used in this study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Waterloolead
- Bausch & Lomb Incorporatedcollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
June 16, 2016
First Posted
June 21, 2016
Study Start
August 1, 2016
Primary Completion
January 30, 2018
Study Completion
February 15, 2018
Last Updated
June 27, 2019
Record last verified: 2019-06
Data Sharing
- IPD Sharing
- Will not share