Trial Outcomes & Findings for The Effect of Xiidra on Comfort and Dryness in Symptomatic Contact Lens Wearers (NCT NCT04297618)

NCT ID: NCT04297618

Last Updated: 2025-05-04

Results Overview

Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort).

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 45 participants
• Primary outcome timeframe: Baseline and 12 weeks
• Results posted on: 2025-05-04

Participant Flow

Participants were recruited at a single site between July 2021 and April 2024. The first participant was enrolled on July 7, 2021 and the last participant was enrolled January 19, 2024.

Out of the 45 participants that were enrolled, 43 met the inclusion critieria, and 42 were dispensed with the study treatment.

Participant milestones

Measure	Xiidra Treatment Each participant will use the same study drops, Xiidra, over the course of the 12-week study. Xiidra: Xiidra (lifitegrast 5% ophthalmic solution)
Overall Study STARTED	42
Overall Study COMPLETED	40
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Xiidra Treatment Each participant will use the same study drops, Xiidra, over the course of the 12-week study. Xiidra: Xiidra (lifitegrast 5% ophthalmic solution)
Overall Study Adverse Event	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Xiidra Treatment n=43 Participants Each participant will use the same study drops, Xiidra, over the course of the 12-week study. Xiidra: Xiidra (lifitegrast 5% ophthalmic solution)
Age, Categorical <=18 years	0 Participants n=43 Participants
Age, Categorical Between 18 and 65 years	42 Participants n=43 Participants
Age, Categorical >=65 years	1 Participants n=43 Participants
Age, Continuous	30.7 years STANDARD_DEVIATION 11.8 • n=43 Participants
Sex: Female, Male Female	36 Participants n=43 Participants
Sex: Female, Male Male	7 Participants n=43 Participants
Region of Enrollment Canada	43 participants n=43 Participants

PRIMARY outcome

Timeframe: Baseline and 12 weeks

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

Participants rate their contact lens-related discomfort on a scale from 0 (no discomfort) to 100 (maximal discomfort).

Outcome measures

Measure	Xiidra Treatment n=40 Participants Each participant will use the same study drops, Xiidra, over the course of the 12-week study. Xiidra: Xiidra (lifitegrast 5% ophthalmic solution)
Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline Baseline	71 score on a scale Interval 8.0 to 93.0
Difference in Contact Lens-related Discomfort at 12 Weeks Compared to Baseline 12 Weeks	11 score on a scale Interval 0.0 to 96.0

PRIMARY outcome

Timeframe: Baseline and 12 weeks

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

Participants rate their contact lens-related dryness on a scale from 0 (no discomfort) to 100 (maximal discomfort).

Outcome measures

Measure	Xiidra Treatment n=40 Participants Each participant will use the same study drops, Xiidra, over the course of the 12-week study. Xiidra: Xiidra (lifitegrast 5% ophthalmic solution)
Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline Baseline	75 score on a scale Interval 40.0 to 96.0
Difference in Contact Lens-related Dryness at 12 Weeks Compared to Baseline 12 Weeks	15 score on a scale Interval 0.0 to 98.0

Adverse Events

Ocular Adverse Events (After Xiidra Was Dispensed)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Systemic Adverse Events (After Xiidra Was Dispensed)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Ocular Adverse Events (Before Xiidra Was Dispensed)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 1 deaths

Systemic Adverse Events (Before Xiidra Was Dispensed)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ocular Adverse Events (After Xiidra Was Dispensed) n=42 participants at risk Ocular adverse events in all participants who were dispensed with the study product.	Systemic Adverse Events (After Xiidra Was Dispensed) n=42 participants at risk Systemic adverse events in all participants who were dispensed with the study product.	Ocular Adverse Events (Before Xiidra Was Dispensed) n=43 participants at risk Ocular adverse events that occurred in all participants that were eligible for the study prior to the study product being dispensed.	Systemic Adverse Events (Before Xiidra Was Dispensed) n=43 participants at risk Systemic adverse events that occurred in all participants that were eligible for the study prior to the study product being dispensed.
Eye disorders Irritated, red eye & purulent discharge	2.4% 1/42 • Number of events 1 • 12 weeks Regular investigator assessment	0.00% 0/42 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment
Eye disorders Bacterial conjunctivitis	4.8% 2/42 • Number of events 2 • 12 weeks Regular investigator assessment	0.00% 0/42 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment
Eye disorders Watery eye	2.4% 1/42 • Number of events 1 • 12 weeks Regular investigator assessment	0.00% 0/42 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment
Infections and infestations COVID	0.00% 0/42 • 12 weeks Regular investigator assessment	4.8% 2/42 • Number of events 2 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment
Vascular disorders Leukocytoclastic vasculitis	0.00% 0/42 • 12 weeks Regular investigator assessment	2.4% 1/42 • Number of events 1 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment
Respiratory, thoracic and mediastinal disorders Sinus infection	0.00% 0/42 • 12 weeks Regular investigator assessment	2.4% 1/42 • Number of events 1 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment
Ear and labyrinth disorders Ear infection	0.00% 0/42 • 12 weeks Regular investigator assessment	2.4% 1/42 • Number of events 1 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment
Skin and subcutaneous tissue disorders Dryness around periorbital eyelid skin	0.00% 0/42 • 12 weeks Regular investigator assessment	2.4% 1/42 • Number of events 1 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment
Eye disorders Corneal sterile infiltrates	0.00% 0/42 • 12 weeks Regular investigator assessment	0.00% 0/42 • 12 weeks Regular investigator assessment	2.3% 1/43 • Number of events 2 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment
Eye disorders Infiltrative keratitis	0.00% 0/42 • 12 weeks Regular investigator assessment	0.00% 0/42 • 12 weeks Regular investigator assessment	2.3% 1/43 • Number of events 2 • 12 weeks Regular investigator assessment	0.00% 0/43 • 12 weeks Regular investigator assessment

Additional Information

Jill Woods

Centre for Ocular Research and Education

Phone: (519) 888-4567

Email: jwoods@uwaterloo.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place