Dry EyePhase 4COLLIENCT04297618

The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers

A Phase 4 study testing Xiidra in people with Dry Eye, run by University of Waterloo at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study to evaluate changes in comfort and dryness in symptomatic contact lens (CL) wearers after using Xiidra (lifitegrast 5.0% ophthalmic solution) for 12 weeks. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Dry Eye
What is being tested?: Xiidra
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 45 participants
Where: 1 siteCanada
Study dates: 7 Jul 2021to 18 Apr 2024
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Is at least 18 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Currently wears daily, soft, frequent replacement lenses (daily, bi-weekly or monthly disposable lenses) in both eyes, that are available in Canada, for a minimum of 5 days/week for 6 hours/day over the last month, and is willing to continue to do so during the study;
Is a symptomatic CL wearer as determined by Eye Dryness Score4,5 (EDS) ≥40 at the end of the wear day AND according to the classification by Young et al7;
Can achieve acceptable lens fit as well as visual acuity (VA) correctable to logMAR +0.20 or better in each eye with their habitual contact lens type;
Has a history of artificial tear or rewetting drop use at least once in the last 30 days;
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;

Who cannot join

Is participating in any concurrent clinical or research study;
Is wearing soft CLs on an extended wear basis (i.e. overnight) or is a rigid gas permeable lens or hybrid lens wearer;
Has a known sensitivity to the investigational product or diagnostic substances (e.g. fluorescein) to be used in the study;
Has any known ocular disease and/or infection, that's either currently active* or has occurred within the previous 30 days;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (examples may include active or uncontrolled systemic conditions such as allergies, autoimmune disease or immunodeficiency disease);
Is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable, including but not limited to topical cyclosporine, any other topical ophthalmic medication, antihistamines, and aspirin;

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Is pregnant, lactating or planning a pregnancy at the time of enrolment (by self-report);**
Has undergone refractive error surgery such as LASIK within the last 12 months;
Has a history of yttrium-aluminium-garnet laser posterior capsulotomy within the previous 6 months,
Is an employee of the Centre for Ocular Research \& Education; * For the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. Mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. Neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre for Ocular Research & Education
Waterloo, Ontario, N2L 3G1

Other trials in Canada

About this study

The purpose of this study to evaluate changes in comfort and dryness in symptomatic contact lens (CL) wearers after using Xiidra (lifitegrast 5.0% ophthalmic solution) for 12 weeks.

Conditions: Dry Eye
Being tested: Xiidra
Medical subject headings: Dry Eye Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

XiidraDrug
Also called Lifitegrast
Xiidra (lifitegrast 5% ophthalmic solution)

Study groups in NCT04297618
Study group	Role	What they receive
Xiidra treatment	Experimental	Each participant will use the same study drops, Xiidra, over the course of the 12-week study. Receives: Drug: Xiidra

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline
Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort).
Measured: Baseline and 12 weeks
Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline
Participants rate their contact lens-related dryness on a scale from 0 (no discomfort) to 100 (maximal discomfort).
Measured: Baseline and 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 202118 Apr 2024

First posted5 Mar 2020
Study start7 Jul 2021
Primary completion18 Apr 2024
Study completion18 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dry EyeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 45 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04297618
Sponsor's protocol ID: 41189
Acronym: COLLIE
Status last verified: Jun 2024
First submitted: 3 Mar 2020
Last updated: 4 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Dry Eye trials

Study at a glance

From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers
ClinicalTrials.gov ID: NCT04297618
Acronym / sponsor ID: COLLIE / 41189
Conditions: Dry Eye
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 45 participants (actual)
Lead sponsor: University of WaterlooUniversity, hospital or other
Collaborators: Novartis
Study start: 7 Jul 2021 (actual)
Primary completion: 18 Apr 2024 (actual)
Study completion: 18 Apr 2024 (actual)
First posted: 5 Mar 2020 (actual)
Results: Posted 4 May 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study to evaluate changes in comfort and dryness in symptomatic contact lens (CL) wearers after using Xiidra (lifitegrast 5.0% ophthalmic solution) for 12 weeks.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Xiidra treatment	Experimental	Drug: XiidraEach participant will use the same study drops, Xiidra, over the course of the 12-week study.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Is at least 18 years of age and has full legal capacity to volunteer;
Has read and signed an information consent letter;
Is willing and able to follow instructions and maintain the appointment schedule;
Currently wears daily, soft, frequent replacement lenses (daily, bi-weekly or monthly disposable lenses) in both eyes, that are available in Canada, for a minimum of 5 days/week for 6 hours/day over the last month, and is willing to continue to do so during the study;
Is a symptomatic CL wearer as determined by Eye Dryness Score4,5 (EDS) ≥40 at the end of the wear day AND according to the classification by Young et al7;

Key exclusion criteria (10 listed)

Is participating in any concurrent clinical or research study;
Is wearing soft CLs on an extended wear basis (i.e. overnight) or is a rigid gas permeable lens or hybrid lens wearer;
Has a known sensitivity to the investigational product or diagnostic substances (e.g. fluorescein) to be used in the study;
Has any known ocular disease and/or infection, that's either currently active* or has occurred within the previous 30 days;
Has a systemic condition that in the opinion of the investigator may affect a study outcome variable (examples may include active or uncontrolled systemic conditions such as allergies, autoimmune disease or immunodeficiency disease);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
XiidraAlso: LifitegrastXiidra (lifitegrast 5% ophthalmic solution)	Drug	Xiidra treatment

Primary outcome

Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline
Time frame: Baseline and 12 weeks
Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort).
Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline
Time frame: Baseline and 12 weeks
Participants rate their contact lens-related dryness on a scale from 0 (no discomfort) to 100 (maximal discomfort).

Results and safety

Results posted to the registry on 4 May 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Xiidra Treatment	42	40

Primary outcome: Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline

Time frame: Baseline and 12 weeks. Median (Full Range). Unit: score on a scale

Measure	Xiidra Treatment n = 40
Baseline	71 (8 to 93)
12 Weeks	11 (0 to 96)

Xiidra Treatment: p <0.01, Wilcoxon (Mann-Whitney)

Population analysed: 2 participants discontinued before the study could be completed.

Primary outcome: Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline

Time frame: Baseline and 12 weeks. Median (Full Range). Unit: score on a scale

Measure	Xiidra Treatment n = 40
Baseline	75 (40 to 96)
12 Weeks	15 (0 to 98)

Xiidra Treatment: p <0.01, Wilcoxon (Mann-Whitney)

Population analysed: 2 participants discontinued before the study could be completed.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ocular Adverse Events (After Xiidra Was Dispensed)	0 of 42 (0%)	3 of 42 (7.1%)	0 of 42
Systemic Adverse Events (After Xiidra Was Dispensed)	0 of 42 (0%)	6 of 42 (14.3%)	0 of 42
Ocular Adverse Events (Before Xiidra Was Dispensed)	0 of 43 (0%)	1 of 43 (2.3%)	1 of 43
Systemic Adverse Events (Before Xiidra Was Dispensed)	0 of 43 (0%)	0 of 43 (0%)	0 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lyndon Jones, PhD, FCOptom principal investigator

Centre for Ocular Research & Education

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Xiidra in people with Dry Eye, run by University of Waterloo at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline (time frame: Baseline and 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04297618.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2025.