Evaluation of Clinical Outcomes After the Use of SYSTANE® HYDRATION
- Conditions
- Dry Eye
- Interventions
- Device: SYSTANE HYDRATION lubricant eye dropsDevice: Hyabak 0.15% eye dropsDrug: 0.9% saline eye drops
- Registration Number
- NCT02470429
- Lead Sponsor
- Alcon Research
- Brief 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.
- Detailed 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 & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 114
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SYSTANE HYDRATION SYSTANE HYDRATION lubricant eye drops SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days SYSTANE HYDRATION 0.9% saline eye drops SYSTANE HYDRATION lubricant eye drops, 1 drop 4 times per day (QID) in each eye for 42 days Hyabak 0.15% Hyabak 0.15% eye drops Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days Hyabak 0.15% 0.9% saline eye drops Hyabak 0.15% eye drops, 1 drop 4 times per day (QID) in each eye for 42 days
- Primary Outcome Measures
Name Time Method Change From Baseline in Total Ocular Surface Staining (TOSS) Score at Day 42 Baseline (Day 0), 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in IDEEL Treatment Effectiveness Score at Day 42 Baseline (Day 0), 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.
Change From Baseline in IDEEL Treatment Inconvenience Score at Day 42 Baseline (Day 0), 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.
Change From Baseline in Tear Film Break-up Time (TFBUT) at Day 42 Baseline (Day 0), 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.
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