Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02470429
• Collaborator: (none)
• Enrollment: 114
• Arms: 2
• Actual Duration (Months): 10.3

Study Details

Study Description

Brief Summary

The purpose of this study is to compare SYSTANE® HYDRATION to Hyabak 0.15% based on total ocular surface staining scores (TOSS) at Day 42.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye	Device: SYSTANE HYDRATION lubricant eye drops; Device: Hyabak 0.15% eye drops; Drug: 0.9% saline eye drops	N/A

Detailed Description

Subjects will first be dispensed preservative-free 0.9% saline eye drops (saline eye drops) to be used during the Run-in phase between Screening Visit and Day 0 (Visit 1). Subjects who qualify will be randomized in a 1:1 manner to receive either treatment with SYSTANE® HYDRATION Lubricant Eye Drops or Hyabak 0.15% Eye Drops.

Study Design

• Study Type: Interventional
• Actual Enrollment: 114 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye
• Actual Study Start Date: Jul 17, 2015
• Actual Primary Completion Date: May 26, 2016
• Actual Study Completion Date: May 26, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SYSTANE HYDRATION SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Device: SYSTANE HYDRATION lubricant eye drops; Preserved with POLYQUAD (polidronium chloride) 0.001%; Other Names: SYSTANE® HYDRATION ; Drug: 0.9% saline eye drops; Preservative-free, one drop 4 times a day in each eye (run-in period)
Active Comparator: Hyabak 0.15% Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Device: Hyabak 0.15% eye drops; Preservative-free; Other Names: Hyabak 0.15% ; Drug: 0.9% saline eye drops; Preservative-free, one drop 4 times a day in each eye (run-in period)

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42 [Baseline (Day 0), Day 42]

   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.

Secondary Outcome Measures

1. Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42 [Baseline (Day 0), Day 42]

   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.

2. Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42 [Baseline (Day 0), Day 42]

   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.

3. Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42 [Baseline (Day 0), Day 42]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Willing and able to attend all study visits;

• Use of non-BAK (Benzalkonium Chloride) artificial tears at least once a day, for at least 3 months prior to Screening Visit;

• Diagnosis of Dry Eye (by a health care professional) for at least 3 months prior to Screening Visit;

• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Women of childbearing potential who are pregnant or breast feeding;

• Any hypersensitivity to the use of the study products or an allergy to any ingredient(s) contained within study products;

• Ocular abnormalities in either eye that could adversely affect the safety or efficacy outcome;

• Active ocular infection (bacterial, viral, or fungal) or active inflammation not associated with dry eye;

• Use of chronic systemic medications: (prescription, over the counter, vitamins/supplements) on a stable dose for less than 30 days prior to Screening Visit, or any anticipated change in dosing regimen during the course of the study;

• History of ocular or intraocular surgery or serious ocular trauma in either eye within 6 months prior to Screening Visit;

• Any medical condition (systemic or ophthalmic) that may, in the opinion of the Investigator, preclude the safe administration of study products or safe participation in the study;

• Use of any topical ocular over-the-counter or prescribed medications in either eye (with the exception of artificial tears/gels/ lubricants) 2 weeks prior to Screening Visit;

• Contact lens use within 2 weeks prior to Screening Visit and unwilling to avoid contact lens use during the course of the study;

• Unwilling to avoid the use of additional artificial tears (other than the study products) throughout the study;

• Other protocol-defined exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Global Trial Leader, Global Development Operations, Alcon, A Novartis Division

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02470429
• Other Study ID Numbers: EXK947-P001
• First Posted: Jun 12, 2015
• Last Update Posted: Jul 2, 2018
• Last Verified: Jun 1, 2017

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dry Eye Syndromes; Keratoconjunctivitis Sicca; Ophthalmic Solutions; Lubricant Eye Drops

Study Results

Participant Flow

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

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

Baseline Characteristics

Arm/Group Title	SYSTANE HYDRATION	Hyabak 0.15%	Total
Arm/Group Description	SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Total of all reporting groups
Overall Participants	50	49	99
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.7 (12.29)	56.7 (14.29)	59.2 (13.49)
Sex: Female, Male (Count of Participants)
Female	41 82%	38 77.6%	79 79.8%
Male	9 18%	11 22.4%	20 20.2%
Total Ocular Surface Staining (TOSS) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.26 (1.411)	4.98 (1.090)	5.12 (1.264)
IDEEL Treatment Score (units on a scale) [Mean (Standard Deviation) ]
Treatment Effectiveness	52.04 (29.602)	51.56 (28.641)	51.80 (28.979)
Treatment Inconvenience	83.42 (17.749)	81.90 (17.829)	82.67 (17.712)
Tear Film Break-up Time (TFBUT) (seconds) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [seconds]	3.20 (2.010)	3.58 (2.222)	3.39 (2.115)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
Description	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.
Time Frame	Baseline (Day 0), Day 42

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SYSTANE HYDRATION	Hyabak 0.15%
Arm/Group Description	SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Measure Participants	48	49
Least Squares Mean (Standard Error) [units on a scale]	-1.16 (0.24)	-0.92 (0.23)

2. Secondary Outcome

Title	Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42
Description	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.
Time Frame	Baseline (Day 0), Day 42

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SYSTANE HYDRATION	Hyabak 0.15%
Arm/Group Description	SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Measure Participants	47	48
Least Squares Mean (Standard Error) [units on a scale]	9.62 (3.19)	12.80 (3.17)

3. Secondary Outcome

Title	Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42
Description	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.
Time Frame	Baseline (Day 0), Day 42

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SYSTANE HYDRATION	Hyabak 0.15%
Arm/Group Description	SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Measure Participants	47	47
Least Squares Mean (Standard Error) [units on a scale]	-10.32 (2.22)	2.24 (2.22)

4. Secondary Outcome

Title	Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42
Description	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.
Time Frame	Baseline (Day 0), Day 42

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	SYSTANE HYDRATION	Hyabak 0.15%
Arm/Group Description	SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days	Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
Measure Participants	48	49
Least Squares Mean (Standard Error) [seconds]	0.39 (0.38)	0.68 (0.37)

Adverse Events

Time Frame	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.
Adverse Event Reporting Description	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.
Arm/Group Title	Pretreatment		SYSTANE HYDRATION		Hyabak 0.15%
Arm/Group Description	All subjects who consented to participate in the study prior to the initiation of study treatment		All subjects treated with SYSTANE HYDRATION lubricant eye drops		All subjects treated with Hyabak 0.15% eye drops
All Cause Mortality
	Pretreatment		SYSTANE HYDRATION		Hyabak 0.15%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/114 (0%)		0/50 (0%)		0/49 (0%)
Serious Adverse Events
	Pretreatment		SYSTANE HYDRATION		Hyabak 0.15%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/114 (0%)		1/50 (2%)		1/49 (2%)
Hepatobiliary disorders
Cholelithiasis	0/114 (0%)		1/50 (2%)		0/49 (0%)
Surgical and medical procedures
Intervertebral disc operation	0/114 (0%)		0/50 (0%)		1/49 (2%)
Other (Not Including Serious) Adverse Events
	Pretreatment		SYSTANE HYDRATION		Hyabak 0.15%
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/114 (1.8%)		12/50 (24%)		6/49 (12.2%)
Eye disorders
Eye irritation	0/114 (0%)		5/50 (10%)		3/49 (6.1%)
Vision blurred	0/114 (0%)		5/50 (10%)		1/49 (2%)
Infections and infestations
Nasopharyngitis	1/114 (0.9%)		5/50 (10%)		1/49 (2%)
Nervous system disorders
Headache	1/114 (0.9%)		0/50 (0%)		3/49 (6.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

Sponsor reserves the right of prior review of any publication or presentation of information related to the study.