Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION

Dry Eye Clinical Trial

Official title:

Evaluation of Clinical Outcomes Following the Use of SYSTANE® HYDRATION in Subjects With Dry Eye

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02470429
• Other study ID #: EXK947-P001
• Status: Completed
• Phase: N/A
• Start date: July 17, 2015
• Est. completion date: May 26, 2016

Study information

• Verified date: June 2017
• Source: Alcon Research
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 114
• Est. completion date: May 26, 2016
• Est. primary completion date: May 26, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Device:
• SYSTANE HYDRATION lubricant eye drops
Preserved with POLYQUAD (polidronium chloride) 0.001%
• Hyabak 0.15% eye drops
Preservative-free

Drug:
• 0.9% saline eye drops
Preservative-free, one drop 4 times a day in each eye (run-in period)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Alcon Research

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Total Ocular Surface Staining (TOSS) Score at 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.	Baseline (Day 0), Day 42
Secondary	Change From Baseline in IDEEL Treatment Effectiveness Score at 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.	Baseline (Day 0), Day 42
Secondary	Change From Baseline in IDEEL Treatment Inconvenience Score at 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.	Baseline (Day 0), Day 42
Secondary	Change From Baseline in Tear Film Break-up Time (TFBUT) at 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.	Baseline (Day 0), Day 42

External Links

•   Results from the Novartis Clinical Trial Results Website