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Trial record 1 of 1 for:    NCT02470429
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Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

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ClinicalTrials.gov Identifier: NCT02470429
Recruitment Status : Completed
First Posted : June 12, 2015
Results First Posted : June 16, 2017
Last Update Posted : July 2, 2018
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Dry Eye
Interventions Device: SYSTANE HYDRATION lubricant eye drops
Device: Hyabak 0.15% eye drops
Drug: 0.9% saline eye drops
Enrollment 114
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 Details 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%
Hide 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
Reason Not Completed
Adverse Event             1             0
Withdrawal by Subject             1             0
Arm/Group Title SYSTANE HYDRATION Hyabak 0.15% Total
Hide 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 Number of Baseline Participants 50 49 99
Hide Baseline Analysis Population Description
This analysis population includes all subjects who were exposed to study drug (including the run-in therapy) (Safety Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 49 participants 99 participants
61.7  (12.29) 56.7  (14.29) 59.2  (13.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 49 participants 99 participants
Female
41
  82.0%
38
  77.6%
79
  79.8%
Male
9
  18.0%
11
  22.4%
20
  20.2%
Total Ocular Surface Staining (TOSS) Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 50 participants 49 participants 99 participants
5.26  (1.411) 4.98  (1.090) 5.12  (1.264)
[1]
Measure 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.
[2]
Measure Analysis Population Description: 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   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Treatment Effectiveness Number Analyzed 49 participants 48 participants 97 participants
52.04  (29.602) 51.56  (28.641) 51.80  (28.979)
Treatment Inconvenience Number Analyzed 49 participants 48 participants 97 participants
83.42  (17.749) 81.90  (17.829) 82.67  (17.712)
[1]
Measure Description: The IDEEL (Impact of dry eye on everyday life) 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.
[2]
Measure Analysis Population Description: ITT Analysis Set. Number Analyzed is the number of subjects with non-missing response.
Tear Film Break-up Time (TFBUT)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Seconds
Number Analyzed 50 participants 49 participants 99 participants
3.20  (2.010) 3.58  (2.222) 3.39  (2.115)
[1]
Measure Description: TFBUT is defined as the time elapsed from the last blink until 1 or more dry spots appeared in the precorneal tear film.
[2]
Measure Analysis Population Description: ITT Analysis Set.
1.Primary Outcome
Title Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42
Hide 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
Hide Outcome Measure Data
Hide 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%
Hide 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
Overall Number of Participants Analyzed 48 49
Least Squares Mean (Standard Error)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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%
Hide 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
Overall Number of Participants Analyzed 47 48
Least Squares Mean (Standard Error)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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%
Hide 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
Overall Number of Participants Analyzed 47 47
Least Squares Mean (Standard Error)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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%
Hide 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
Overall Number of Participants Analyzed 48 49
Least Squares Mean (Standard Error)
Unit of Measure: seconds
0.39  (0.38) 0.68  (0.37)
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%
Hide 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   0/50 (0.00%)   0/49 (0.00%) 
Hide Serious Adverse Events
Pretreatment SYSTANE HYDRATION Hyabak 0.15%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/114 (0.00%)   1/50 (2.00%)   1/49 (2.04%) 
Hepatobiliary disorders       
Cholelithiasis  1  0/114 (0.00%)  1/50 (2.00%)  0/49 (0.00%) 
Surgical and medical procedures       
Intervertebral disc operation  1  0/114 (0.00%)  0/50 (0.00%)  1/49 (2.04%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pretreatment SYSTANE HYDRATION Hyabak 0.15%
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   2/114 (1.75%)   12/50 (24.00%)   6/49 (12.24%) 
Eye disorders       
Eye irritation  1  0/114 (0.00%)  5/50 (10.00%)  3/49 (6.12%) 
Vision blurred  1  0/114 (0.00%)  5/50 (10.00%)  1/49 (2.04%) 
Infections and infestations       
Nasopharyngitis  1  1/114 (0.88%)  5/50 (10.00%)  1/49 (2.04%) 
Nervous system disorders       
Headache  1  1/114 (0.88%)  0/50 (0.00%)  3/49 (6.12%) 
1
Term from vocabulary, MedDRA (18.0)
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Sponsor reserves the right of prior review of any publication or presentation of information related to the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: WW Medical Affairs Director, GMA Ophthalmics
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
EMail: alcon.medinfo@alcon.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02470429    
Other Study ID Numbers: EXK947-P001
First Submitted: June 10, 2015
First Posted: June 12, 2015
Results First Submitted: April 4, 2017
Results First Posted: June 16, 2017
Last Update Posted: July 2, 2018