Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye

• Sponsor: Alcon Research (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02446015
• Collaborator: (none)
• Enrollment: 159
• Arms: 2
• Actual Duration (Months): 12.1

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the clinical benefits of SYSTANE® ULTRA Lubricant Eye Drops using total ocular surface staining scores in subjects with dry eye administering it either as a scheduled regimen or as-needed after 28 days of treatment.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Syndrome	Drug: SYSTANE® ULTRA Lubricant Eye Drops	N/A

Detailed Description

This study consists of a 14-day Run-in Phase (between the Screening Visit and Baseline/Visit

1. and a Treatment Phase. During the Run-in Phase, subjects will discontinue current artificial tears and will be dispensed SYSTANE® ULTRA to be administered 1 drop in each eye as needed (PRN). Subjects who meet the re-evaluation criteria after the Run-in Phase will be randomized in a 1:2 manner to receive treatment with SYSTANE® ULTRA 4 times per day (QID) or PRN, respectively, for 28 days.

Study Design

• Study Type: Interventional
• Actual Enrollment: 159 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation Following Use of SYSTANE® ULTRA in the Management of Dry Eye
• Actual Study Start Date: Jun 19, 2015
• Actual Primary Completion Date: Jun 21, 2016
• Actual Study Completion Date: Jun 21, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systane Ultra QID SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days	Drug: SYSTANE® ULTRA Lubricant Eye Drops; Other Names: SYSTANE® ULTRA
Active Comparator: Systane Ultra PRN SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days	Drug: SYSTANE® ULTRA Lubricant Eye Drops; Other Names: SYSTANE® ULTRA

Outcome Measures

Primary Outcome Measures

1. Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28 [Baseline (Day 0), Day 28]

   The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is "Absent" and 5 is "Severe." The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.

Secondary Outcome Measures

1. Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28 [Baseline (Day 0), Day 28]

   The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.

2. Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28 [Baseline (Day 0), Day 28]

   The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.

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 BAK-free artificial tear drops on an as needed basis, at least once a week, for at least 3 months prior to Screening Visit (maximum use of 4 drops a day).

• At least one '8 hour waking period' per week during the run-in phase without using the provided artificial tear.

• Use provided artificial tear at least once a week during run-in phase.

• Willing to take study treatment as directed for the entire study and able to complete the study diaries as required.

• Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

• Use of artificial tears, as specified in the protocol.

• Use of topical ocular medications, as specified in the protocol.

• Women of childbearing potential who are pregnant, breast feeding, plan to become pregnant during the study, or not using adequate birth control methods to prevent pregnancy throughout the study.

• Any hypersensitivity to the use of the study product formulations or an allergy to any ingredient(s) contained within product formulations.

• Ocular abnormalities, infection, or active inflammation (not associated with dry eye) as specified in the protocol.

• Ocular or intraocular surgery or serious ocular trauma in either eye within the past 6 months prior to Screening Visit.

• Any medical condition (systemic or ophthalmic) that may preclude the safe administration of test article or safe participation in the study.

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

• Other protocol-specified exclusion criteria may apply.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Alcon Research

Investigators

• Study Director: Sr. Clinical Manager, GCRA, Alcon Research

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alcon Research
• ClinicalTrials.gov Identifier: NCT02446015
• Other Study ID Numbers: EXC120-P001
• First Posted: May 15, 2015
• Last Update Posted: Jul 2, 2018
• Last Verified: Apr 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 6 study centers located in the US and 2 study centers located in Australia.
Pre-assignment Detail	Of the 159 enrolled, 58 subjects were exited as screen failures prior to randomization. An additional 4 subjects were randomized in error and did not receive investigational product (IP). This reporting group includes all treated subjects (97).

Arm/Group Title	Systane Ultra QID	Systane Ultra PRN
Arm/Group Description	SYSTANE® ULTRA lubricant eye drops,1 drop in each eye, 4 times per day (QID) for 28 days	SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye, as needed (PRN) for 28 days
Period Title: Overall Study
STARTED	34	63
COMPLETED	33	62
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Systane Ultra QID	Systane Ultra PRN	Total
Arm/Group Description	SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days	SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days	Total of all reporting groups
Overall Participants	34	63	97
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	47.2 (16.6)	52.2 (18.1)	50.4 (17.7)
Sex: Female, Male (Count of Participants)
Female	26 76.5%	51 81%	77 79.4%
Male	8 23.5%	12 19%	20 20.6%
Total Ocular Surface Staining (TOSS) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	5.1 (1.28)	5.0 (1.07)	5.0 (1.14)
Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	43.20 (11.049)	46.75 (9.854)	45.50 (10.372)
IDEEL Treatment Satisfaction Scores (units on a scale) [Mean (Standard Deviation) ]
Effectiveness	57.17 (20.708)	57.54 (20.428)	57.41 (20.419)
Inconvenience	84.38 (15.329)	84.03 (14.189)	84.15 (14.520)

Outcome Measures

1. Primary Outcome

Title	Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28
Description	The TOSS score is a cumulative cornea and conjunctival staining score. After instilling ophthalmic dye in the eye, the investigator graded three areas of the ocular surface for dryness on a scale from 0 to 5, where 0 is "Absent" and 5 is "Severe." The three scores were summed for a resultant overall 0-15 score. The change from baseline was calculated as the TOSS score at Day 28 minus the TOSS score at baseline. A more negative change value indicates greater efficacy. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
Time Frame	Baseline (Day 0), Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.

Arm/Group Title	Systane Ultra QID	Systane Ultra PRN
Arm/Group Description	SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days	SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
Measure Participants	33	62
Least Squares Mean (Standard Error) [units on a scale]	-1.19 (0.26)	-0.94 (0.24)

2. Secondary Outcome

Title	Change From Baseline in Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score at Day 28
Description	The IDEEL SB module is a 20 question patient reported outcome questionnaire that assesses the subject's symptoms of dry eye. An overall resultant calculated score ranges from 0 to 100, with higher scores indicating greater symptom bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
Time Frame	Baseline (Day 0), Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.

Arm/Group Title	Systane Ultra QID	Systane Ultra PRN
Arm/Group Description	SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days	SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
Measure Participants	33	62
Least Squares Mean (Standard Error) [units on a scale]	-7.00 (2.01)	-2.94 (1.85)

3. Secondary Outcome

Title	Change From Baseline in IDEEL Treatment Satisfaction Scores (Treatment Effectiveness and Treatment-related Inconvenience) at Day 28
Description	The IDEEL is 10-question patient-reported outcome questionnaire that assesses the subject's general satisfaction with treatment use (Treatment Effectiveness and Treatment Inconvenience). A resultant overall 0-100 treatment satisfaction score was calculated separately for Treatment Effectiveness and Treatment Inconvenience, with higher scores indicating greater satisfaction and less treatment-related bother. One eye from each subject was chosen as the study eye and only the study eye was used for eye-level efficacy analyses.
Time Frame	Baseline (Day 0), Day 28

Outcome Measure Data

Analysis Population Description

Intent-to-Treat Analysis Set. Number Analyzed is the number of subjects with non-missing response.

Arm/Group Title	Systane Ultra QID	Systane Ultra PRN
Arm/Group Description	SYSTANE® ULTRA lubricant eye drops,1 drop in each eye QID for 28 days	SYSTANE® ULTRA lubricant eye drops, 1 drop in each eye PRN for 28 days
Measure Participants	33	62
Effectiveness	2.43 (3.53)	0.16 (3.21)
Inconvenience	-11.56 (2.94)	-2.77 (2.67)

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 6 weeks). AEs are reported as pre-treatment and treatment-emergent
Adverse Event Reporting Description	An AE was defined as any untoward medical occurrence in a subject who is administered a study treatment regardless of whether or not the event has a causal relationship with the treatment. AEs were obtained through solicited and spontaneous comments from participants and through observations by the Investigator as outlined in the study protocol.
Arm/Group Title	Pretreatment		Systane Ultra QID		Systane Ultra PRN
Arm/Group Description	All subjects who consented to participate in the study prior to the initiation of study treatment		All subjects treated with SYSTANE® ULTRA lubricant eye drops QID		All subjects treated with SYSTANE® ULTRA lubricant eye drops PRN
All Cause Mortality
	Pretreatment		Systane Ultra QID		Systane Ultra PRN
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/159 (0%)		0/34 (0%)		0/63 (0%)
Serious Adverse Events
	Pretreatment		Systane Ultra QID		Systane Ultra PRN
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/159 (0%)		0/34 (0%)		0/63 (0%)
Other (Not Including Serious) Adverse Events
	Pretreatment		Systane Ultra QID		Systane Ultra PRN
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/159 (0%)		0/34 (0%)		0/63 (0%)

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.