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

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ClinicalTrials.gov Identifier: NCT02446015
Recruitment Status : Completed
First Posted : May 15, 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: Single (Investigator);   Primary Purpose: Treatment
Condition Dry Eye Syndrome
Intervention Drug: SYSTANE® ULTRA Lubricant Eye Drops
Enrollment 159
Recruitment Details Subjects were recruited from 6 study centers located in the US and 2 study centers located in Australia.
Pre-assignment Details 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
Hide 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
Reason Not Completed
Adverse Event             0             1
Withdrawal by Subject             1             0
Arm/Group Title Systane Ultra QID Systane Ultra PRN Total
Hide 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 Number of Baseline Participants 34 63 97
Hide Baseline Analysis Population Description
This analysis population includes all randomized subjects who received at least 1 dose of the randomized investigational product (Intent-to-Treat Analysis Set).
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 34 participants 63 participants 97 participants
47.2  (16.6) 52.2  (18.1) 50.4  (17.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 34 participants 63 participants 97 participants
Female
26
  76.5%
51
  81.0%
77
  79.4%
Male
8
  23.5%
12
  19.0%
20
  20.6%
Total Ocular Surface Staining (TOSS) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 34 participants 63 participants 97 participants
5.1  (1.28) 5.0  (1.07) 5.0  (1.14)
[1]
Measure 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.
Impact of Dry Eye on Everyday Life Symptom-Bother (IDEEL SB) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 34 participants 63 participants 97 participants
43.20  (11.049) 46.75  (9.854) 45.50  (10.372)
[1]
Measure 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.
IDEEL Treatment Satisfaction Scores   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 34 participants 63 participants 97 participants
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)
[1]
Measure 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.
1.Primary Outcome
Title Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 28
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 33 62
Least Squares Mean (Standard Error)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 33 62
Least Squares Mean (Standard Error)
Unit of Measure: 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
Hide 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
Hide Outcome Measure Data
Hide 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
Hide 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
Overall Number of Participants Analyzed 33 62
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Effectiveness 2.43  (3.53) 0.16  (3.21)
Inconvenience -11.56  (2.94) -2.77  (2.67)
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
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® 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 (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/159 (0.00%)   0/34 (0.00%)   0/63 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Pretreatment Systane Ultra QID Systane Ultra PRN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/159 (0.00%)   0/34 (0.00%)   0/63 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pretreatment Systane Ultra QID Systane Ultra PRN
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/159 (0.00%)   0/34 (0.00%)   0/63 (0.00%) 
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
Name/Title: WW Medical Affairs Director, GMA Ophthalmics
Organization: Alcon, A Novartis Division
Phone: 1-888-451-3937
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT02446015     History of Changes
Other Study ID Numbers: EXC120-P001
First Submitted: May 13, 2015
First Posted: May 15, 2015
Results First Submitted: April 4, 2017
Results First Posted: June 16, 2017
Last Update Posted: July 2, 2018