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โ† Trials
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The Effectiveness of Systane PRO Preservative Free Verses Blink Triple Care Preservative Free

RecruitingPhase 4Ages 18 Years - anyAllGordon Schanzlin New Vision
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In plain words

What the trial is, and whether it could suit you

The goal of this investigational study is to determine if Systane PRO Preservative Free is non-inferior to BLINK TRIPLE CARE in the clinically significant improvement of signs and symptoms of dry eye in patients over 4 weeks.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Age: Adults โ‰ฅ 18 years. * Diagnosis: Clinical diagnosis of mild to moderate dry eye disease in at least one eye with OSDI โ‰ฅ 13 to โ‰ค 32 at screening. * OSDI โ‰ฅ 13 to โ‰ค 32 at screening. * Objective evidence: NITBUT โ‰ค 10 seconds in the study eye(s) at screening. * Ocular surface status: CFS โ‰ค grade 3 (Oxford or NEI scale) in the study eye(s). * Stable medications: Systemic medications that may affect tear film must be stable โ‰ฅ 30 days prior to screening and expected to remain stable during the study. * Ability to participate: Able and willing to comply with procedures, attend visits, and provide written informed consent. * Contraception: Women of childbearing potential must agree to use an acceptable method of contraception for the study duration and have a negative pregnancy test at screening. Exclusion Criteria: * Active ocular infection or inflammation unrelated to DED (e.g., bacterial/viral conjunctivitis, active uveitis). * Severe ocular surface disease beyond typical DED (e.g., severe keratitis, Stevens-Johnson syndrome, ocular cicatricial pemphigoid). * Excessive corneal staining: CFS \> grade 3 in the study eye(s). * Recent ocular surgery or procedure: ocular surgery, laser, or punctal occlusion within 6 months prior to screening. * Current or prior use within 6 months before screening of either study drop (Systane PRO PF or Blink Triple Care PF) * Contact lens wear: soft or rigid contact lens use within 7 days prior to baseline, or unwillingness to discontinue lenses for the study; consider extending to 14 days if desired. * Use of topical ophthalmic medications that cannot be discontinued (e.g., topical antibiotics, corticosteroids). * Recent investigational product use: participation in another interventional trial or investigational product use within 30 days prior to screening. * Known hypersensitivity: allergy to any component of Systane PRO PF or Blink Triple Care PF. * Confounding systemic conditions: systemic diseases or medications that, in the investigator's judgment, could significantly affect tear production or ocular surface health (e.g., uncontrolled autoimmune disease, recent initiation/change of systemic medications known to affect tear production within 30 days). * Severe visual impairment in the study eye(s) not attributable to DED that would interfere with assessments. * Pregnancy or breastfeeding. * Investigator discretion: any medical, psychiatric, or social condition that would preclude safe participation or reliable completion of study procedures.
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What it tests

  • Systane PRO
  • Blink tears
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Where

1 site
Gordon Schanzlin New Vision Institute
La Jolla, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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