Trial Outcomes & Findings for Clinical Evaluation of Two Marketed Artificial Tears in Non-contact Lens Wearing Patients (NCT NCT03466086)

Results Overview

Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

57 participants

Primary outcome timeframe

1-Week Follow-up

Results posted on

2019-06-28

Participant Flow

A total of 57 subjects were enrolled in this study, of which 55 subjects were assigned to receive at least 1 eye drop while, 2 subjects were screen failures and/or not assigned. Of the total assigned subjects, 53 subjects completed the study and 2 subjects discontinued the study.

Participant milestones

Participant milestones
Measure	Test/Control Subjects randomized to this sequence received the Test eye drop during the first period and then received the Control eye drop during the second period.	Control/Test Subjects randomized to this sequence received the Control eye drop during the first period and then received the Test eye drop during the second period.
Period 1 STARTED	28	27
Period 1 COMPLETED	26	27
Period 1 NOT COMPLETED	2	0
Period 2 STARTED	26	27
Period 2 COMPLETED	26	27
Period 2 NOT COMPLETED	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Test/Control Subjects randomized to this sequence received the Test eye drop during the first period and then received the Control eye drop during the second period.	Control/Test Subjects randomized to this sequence received the Control eye drop during the first period and then received the Test eye drop during the second period.
Period 1 Sponsor decision due to study timeline	1	0
Period 1 Withdrawal by Subject	1	0

Baseline Characteristics

Clinical Evaluation of Two Marketed Artificial Tears in Non-contact Lens Wearing Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Dispensed Subjects n=55 Participants All subjects dispensed at least one eye drop and 1 contact lens
Age, Continuous	26.76 Years STANDARD_DEVIATION 11.273 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants
Sex: Female, Male Male	18 Participants n=5 Participants
Race/Ethnicity, Customized Asian	13 Participants n=5 Participants
Race/Ethnicity, Customized Black Or African American	4 Participants n=5 Participants
Race/Ethnicity, Customized White	34 Participants n=5 Participants
Race/Ethnicity, Customized Other	4 Participants n=5 Participants
Region of Enrollment United Kingdom	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1-Week Follow-up

Population: All subjects that completed all study visits without a major protocol deviation.

Ocular comfort was measured using the visual analogue scale of 0 to 100. Where 0 is extremely uncomfortable and 100 is extremely comfortable.

Outcome measures

Outcome measures
Measure	Test n=104 eyes All subjects that wore the Test eye drop during either the first or second period of the study.	Control n=104 eyes All subjects that wore the control eye drop in either the first or second period of the study.
Ocular Comfort	81.96 Units on a scale Standard Deviation 12.407	82.49 Units on a scale Standard Deviation 15.238

SECONDARY outcome

Timeframe: 1-Week Follow-up

Population: All subjects that completed all study visits without a major protocol deviation.

Subjective dryness was assessed using Ocular Surface Disease Index (OSDI©) instrument. Dryness is evaluated on a scale of 0 to 100, where higher scores indicate more symptoms of dryness

Outcome measures

Outcome measures
Measure	Test n=52 Participants All subjects that wore the Test eye drop during either the first or second period of the study.	Control n=52 Participants All subjects that wore the control eye drop in either the first or second period of the study.
Subjective Dryness Rating	25.68 Units on a Scale Standard Deviation 10.162	24.69 Units on a Scale Standard Deviation 10.609

Adverse Events

Test

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Meredith Bishop, OD, MS, FAAO

Johnson & Johnson Vision

Phone: 904-443-1396

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60