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Evaluation of SYSTANE Ultra Lubricant Eye Drops

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ClinicalTrials.gov Identifier: NCT00702377
Recruitment Status : Completed
First Posted : June 20, 2008
Results First Posted : February 10, 2010
Last Update Posted : February 2, 2012
Sponsor:
Information provided by (Responsible Party):
Alcon Research

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Dry Eye
Interventions Other: SYSTANE Ultra
Other: Optive
Enrollment 109
Recruitment Details 109 dry eye subjects
Pre-assignment Details Randomized, double-masked, parallel design
Arm/Group Title SYSTANE Ultra OPTIVE Lubricant Eye Drops
Hide Arm/Group Description SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Period Title: Overall Study
Started 53 56
Completed 52 53
Not Completed 1 3
Arm/Group Title SYSTANE Ultra OPTIVE Lubricant Eye Drops Total
Hide Arm/Group Description SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days Total of all reporting groups
Overall Number of Baseline Participants 53 56 109
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 56 participants 109 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
34
  64.2%
43
  76.8%
77
  70.6%
>=65 years
19
  35.8%
13
  23.2%
32
  29.4%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants 56 participants 109 participants
Female
39
  73.6%
41
  73.2%
80
  73.4%
Male
14
  26.4%
15
  26.8%
29
  26.6%
1.Primary Outcome
Title Tear Break-up Time
Hide Description Tear breakup time is the time interval between a blink and the development of a dry spot in the tear film. Less than 10 seconds is abnormal. Dry spot is visible after fluorescein staining when viewed under a slit-lamp.
Time Frame Day 0, Day 7, Day 14, Day 28, and Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYSTANE Ultra OPTIVE Lubricant Eye Drops
Hide Arm/Group Description:
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: seconds
Day 0 4.2  (1.9) 4.5  (2.3)
Day 7 4.7  (2.8) 4.2  (1.8)
Day 14 4.8  (2.8) 4.2  (1.8)
Day 28 4.6  (2.6) 5.2  (3.2)
Day 42 4.5  (2.3) 4.2  (2.3)
2.Primary Outcome
Title Conjunctival Staining
Hide Description Conjunctival staining refers to the appearance of spots on the conjunctiva when dyed with lissamine green stain during an eye examination. Lissamine green temporarily stains the surface of the conjunctiva of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the spots as green spots. Conjunctival staining grading scale is a 6 point scale, with 0 equals no staining (best case) and 6 equals maximum (worst) staining.
Time Frame Day 0, Day 7, Day 14, Day 28, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYSTANE Ultra OPTIVE Lubricant Eye Drops
Hide Arm/Group Description:
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 0 2.3  (1.1) 2.8  (1.4)
Day 7 2.1  (1.1) 2.5  (1.3)
Day 14 2.0  (1.2) 2.2  (1.4)
Day 28 1.9  (1.1) 2.4  (1.5)
Day 42 1.9  (1.0) 2.7  (1.4)
3.Primary Outcome
Title Corneal Staining
Hide Description Corneal staining refers to the appearance of corneal abrasions when dyed with fluorescein drops during an eye examination. Fluorescein temporarily stains the surface of the cornea of the eye. An eye doctor looking at the eye's surface through a slit lamp observes the abrasions as brightly-colored spots on an otherwise smooth cornea. Corneal staining grading scale is a 15 point scale, with 0 equals no staining (best case) and 15 equals maximum (worst) staining.
Time Frame Day 0, Day 7, Day 14, Day 28, Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title SYSTANE Ultra OPTIVE Lubricant Eye Drops
Hide Arm/Group Description:
SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
Overall Number of Participants Analyzed 53 56
Mean (Standard Deviation)
Unit of Measure: Units on a scale
Day 0 4.8  (1.8) 5.3  (2.5)
Day 7 3.6  (2.2) 4.3  (3.0)
Day 14 2.9  (2.1) 4.5  (2.9)
Day 28 3.1  (2.1) 3.8  (2.6)
Day 42 2.9  (1.8) 4.2  (2.8)
Time Frame From Day 0 to Day 42.
Adverse Event Reporting Description Adverse events were both volunteered and solicited.
 
Arm/Group Title SYSTANE Ultra OPTIVE Lubricant Eye Drops
Hide Arm/Group Description SYSTANE Ultra Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days OPTIVE Lubricant Eye Drops 1 drop each eye 4 times daily for 42 days
All-Cause Mortality
SYSTANE Ultra OPTIVE Lubricant Eye Drops
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
SYSTANE Ultra OPTIVE Lubricant Eye Drops
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/53 (0.00%)      0/56 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
SYSTANE Ultra OPTIVE Lubricant Eye Drops
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/53 (5.66%)      0/56 (0.00%)    
Infections and infestations     
Urinary Tract Infection  1  3/53 (5.66%)  3 0/56 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 11.0
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.
The PI should hold confidential, and not disclose directly or indirectly to any third party other than Contractors, the data arising out of the study. Alcon 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: Alcon Clinical
Organization: Alcon Research Ltd
Phone: 888.451.3937; 817.568.6725
EMail: medinfo@alconlabs.com
Layout table for additonal information
Responsible Party: Alcon Research
ClinicalTrials.gov Identifier: NCT00702377    
Other Study ID Numbers: C-07-33
First Submitted: June 19, 2008
First Posted: June 20, 2008
Results First Submitted: September 23, 2009
Results First Posted: February 10, 2010
Last Update Posted: February 2, 2012