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Integrin antagonist
Xiidra for Dry Eye Syndrome (COLLIE Trial)
Phase 4
Recruiting
Led By Lyndon Jones, PhD, FCOptom
Research Sponsored by University of Waterloo
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Is willing to use the Xiidra study drops twice a day on a daily basis (irrespective of CL wear) and to stop use of any habitual rewetting drops and/or artificial tears over the course of the 12-week treatment phase
Has a history of artificial tear or rewetting drop use at least once in the last 30 days
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 12 weeks
Awards & highlights
COLLIE Trial Summary
This trial found that Xiidra helped reduce symptoms and improve dryness in people who wear contact lenses.
Who is the study for?
This trial is for adults over 18 who wear soft contact lenses daily, experience dry eyes, and are willing to use Xiidra drops twice a day. They must have used artificial tears in the last month but can't join if they're pregnant, on certain medications that affect dry eye symptoms, or have had recent eye surgery.Check my eligibility
What is being tested?
The study tests whether Xiidra (lifitegrast ophthalmic solution) improves comfort and reduces dryness in people who wear contact lenses and suffer from dry eyes. Participants will use Xiidra for 12 weeks to see if there's an improvement.See study design
What are the potential side effects?
Xiidra may cause side effects such as irritation at the application site, altered taste sensation, reduced visual acuity shortly after administration, or discomfort in the eyes.
COLLIE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to use Xiidra drops twice daily and will stop using other eye drops for 12 weeks.
Select...
I have used artificial tears or rewetting drops in the last month.
Select...
I am 18 or older and can legally consent.
Select...
I can follow instructions and keep appointments.
COLLIE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in contact lens-related discomfort at 12 weeks compared to baseline
Difference in contact lens-related dryness at 12 weeks compared to baseline
Side effects data
From 2015 Phase 3 trial • 711 Patients • NCT0228451618%
Instillation site irritation
13%
Instillation site reaction
13%
Dysgeusia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Lifitegrast
COLLIE Trial Design
1Treatment groups
Experimental Treatment
Group I: Xiidra treatmentExperimental Treatment1 Intervention
Each participant will use the same study drops, Xiidra, over the course of the 12-week study.
Find a Location
Who is running the clinical trial?
University of WaterlooLead Sponsor
124 Previous Clinical Trials
209,478 Total Patients Enrolled
NovartisIndustry Sponsor
1,610 Previous Clinical Trials
2,719,200 Total Patients Enrolled
Lyndon Jones, PhD, FCOptomPrincipal InvestigatorCentre for Ocular Research & Education
12 Previous Clinical Trials
421 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am willing to use Xiidra drops twice daily and will stop using other eye drops for 12 weeks.I had LASIK or similar eye surgery in the last year.You are able to wear contact lenses that fit well and provide clear vision, with each eye having a visual acuity of logMAR +0.20 or better when wearing your usual contact lens type.I am not on medications that could affect the study results, like eye drops or antihistamines.I had a YAG laser eye procedure in the last 6 months.I have an eye disease or infection that is active or was active in the last 30 days.You are known to have a sensitivity or allergy to the study drug or any substances used for testing in the study.I have used artificial tears or rewetting drops in the last month.You have a health condition that could potentially affect the results of the study, like allergies, autoimmune diseases, or weakened immune system.I wear contact lenses overnight or use rigid gas permeable/hybrid lenses.I am 18 or older and can legally consent.I can follow instructions and keep appointments.
Research Study Groups:
This trial has the following groups:- Group 1: Xiidra treatment
Awards:
This trial has 3 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Drug Has Already Been Approved - The FDA has already approved this drug, and is just seeking more data.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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