Trial Outcomes & Findings for Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION (NCT NCT02470429)

NCT ID: NCT02470429

Last Updated: 2018-07-02

Results Overview

The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 114 participants
• Primary outcome timeframe: Baseline (Day 0), Day 42
• Results posted on: 2018-07-02

Participant Flow

Subjects were recruited from 3 study centers located in Germany, 3 study centers located in France, 2 study centers located in the UK, and 2 study centers located in Spain.

Of the 114 enrolled, 15 subjects were exited as screen failures prior to randomization. This reporting group includes all randomized subjects (99).

Participant milestones

Measure	SYSTANE HYDRATION SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Overall Study STARTED	50	49
Overall Study COMPLETED	48	49
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	SYSTANE HYDRATION SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Overall Study Adverse Event	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

This analysis population includes all subjects who received at least 1 dose of the randomized study drug (Intent-to-Treat (ITT) Analysis Set).

Baseline characteristics by cohort

Measure	SYSTANE HYDRATION n=50 Participants SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% n=49 Participants Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Total n=99 Participants Total of all reporting groups
Age, Continuous	61.7 years STANDARD_DEVIATION 12.29 • n=50 Participants	56.7 years STANDARD_DEVIATION 14.29 • n=49 Participants	59.2 years STANDARD_DEVIATION 13.49 • n=99 Participants
Sex: Female, Male Female	41 Participants n=50 Participants	38 Participants n=49 Participants	79 Participants n=99 Participants
Sex: Female, Male Male	9 Participants n=50 Participants	11 Participants n=49 Participants	20 Participants n=99 Participants
Total Ocular Surface Staining (TOSS) Score	5.26 units on a scale STANDARD_DEVIATION 1.411 • n=50 Participants • This analysis population includes all subjects who received at least 1 dose of the randomized study drug (Intent-to-Treat (ITT) Analysis Set).	4.98 units on a scale STANDARD_DEVIATION 1.090 • n=49 Participants • This analysis population includes all subjects who received at least 1 dose of the randomized study drug (Intent-to-Treat (ITT) Analysis Set).	5.12 units on a scale STANDARD_DEVIATION 1.264 • n=99 Participants • This analysis population includes all subjects who received at least 1 dose of the randomized study drug (Intent-to-Treat (ITT) Analysis Set).
IDEEL Treatment Score Treatment Effectiveness	52.04 units on a scale STANDARD_DEVIATION 29.602 • n=49 Participants • ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.	51.56 units on a scale STANDARD_DEVIATION 28.641 • n=48 Participants • ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.	51.80 units on a scale STANDARD_DEVIATION 28.979 • n=97 Participants • ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.
IDEEL Treatment Score Treatment Inconvenience	83.42 units on a scale STANDARD_DEVIATION 17.749 • n=49 Participants • ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.	81.90 units on a scale STANDARD_DEVIATION 17.829 • n=48 Participants • ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.	82.67 units on a scale STANDARD_DEVIATION 17.712 • n=97 Participants • ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.
Tear Film Break-up Time (TFBUT)	3.20 seconds STANDARD_DEVIATION 2.010 • n=50 Participants • ITT Analysis Set.	3.58 seconds STANDARD_DEVIATION 2.222 • n=49 Participants • ITT Analysis Set.	3.39 seconds STANDARD_DEVIATION 2.115 • n=99 Participants • ITT Analysis Set.

PRIMARY outcome

Timeframe: Baseline (Day 0), Day 42

Population: ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.

The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded 3 areas of the ocular surface for dryness on a scale from 0 to 5, where 0=Absent and 5=Severe. The 3 scores were summed for a resultant overall 0-15 score. A more negative change value indicates greater efficacy. One eye (study eye) contributed to the analysis.

Outcome measures

Measure	SYSTANE HYDRATION n=48 Participants SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% n=49 Participants Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42	-1.16 units on a scale Standard Error 0.24	-0.92 units on a scale Standard Error 0.23

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 42

Population: ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.

The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.

Outcome measures

Measure	SYSTANE HYDRATION n=47 Participants SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% n=48 Participants Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42	9.62 units on a scale Standard Error 3.19	12.80 units on a scale Standard Error 3.17

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 42

Population: ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.

The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use. A resultant overall 0-100 satisfaction score was calculated, with a higher score indicating greater satisfaction and less treatment-related bother.

Outcome measures

Measure	SYSTANE HYDRATION n=47 Participants SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% n=47 Participants Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42	-10.32 units on a scale Standard Error 2.22	2.24 units on a scale Standard Error 2.22

SECONDARY outcome

Timeframe: Baseline (Day 0), Day 42

Population: ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.

TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film. A longer tear film break-up time indicates a more stable tear film and may lead to improvement in dry eye symptoms. One eye (study eye) contributed to the analysis.

Outcome measures

Measure	SYSTANE HYDRATION n=48 Participants SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% n=49 Participants Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42	0.39 seconds Standard Error 0.38	0.68 seconds Standard Error 0.37

Adverse Events

Pretreatment

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

SYSTANE HYDRATION

Serious events: 1 serious events

Other events: 12 other events

Deaths: 0 deaths

Hyabak 0.15%

Serious events: 1 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Measure	Pretreatment n=114 participants at risk All subjects who consented to participate in the study prior to the initiation of study treatment	SYSTANE HYDRATION n=50 participants at risk All subjects treated with SYSTANE HYDRATION lubricant eye drops	Hyabak 0.15% n=49 participants at risk All subjects treated with Hyabak 0.15% eye drops
Surgical and medical procedures Intervertebral disc operation	0.00% 0/114 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	0.00% 0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	2.0% 1/49 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.
Hepatobiliary disorders Cholelithiasis	0.00% 0/114 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	2.0% 1/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	0.00% 0/49 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.

Other adverse events

Measure	Pretreatment n=114 participants at risk All subjects who consented to participate in the study prior to the initiation of study treatment	SYSTANE HYDRATION n=50 participants at risk All subjects treated with SYSTANE HYDRATION lubricant eye drops	Hyabak 0.15% n=49 participants at risk All subjects treated with Hyabak 0.15% eye drops
Eye disorders Eye irritation	0.00% 0/114 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	10.0% 5/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	6.1% 3/49 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.
Eye disorders Vision blurred	0.00% 0/114 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	10.0% 5/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	2.0% 1/49 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.
Infections and infestations Nasopharyngitis	0.88% 1/114 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	10.0% 5/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	2.0% 1/49 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.
Nervous system disorders Headache	0.88% 1/114 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	0.00% 0/50 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.	6.1% 3/49 • Adverse events (AEs) were collected from time of consent for the duration of a subject's participation in the study (up to 63 days). AEs are reported as pretreatment and treatment-emergent. An AE was defined as any untoward medical occurrence in a subject who was administered an investigational product regardless of whether or not the event had a causal relationship with the treatment. AEs were obtained through volunteered and elicited comments from subjects and through observations by the Investigator.

Additional Information

WW Medical Affairs Director, GMA Ophthalmics

Alcon, A Novartis Division

Phone: 1-888-451-3937

Email: alcon.medinfo@alcon.com

Results disclosure agreements

• Principal investigator is a sponsor employee Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
• Publication restrictions are in place

Restriction type: OTHER