Dry Eye Disease study: Systane PRO vs Blink tears
Official title The Effectiveness of Systane PRO Preservative Free Verses Blink Triple Care Preservative Free
ClinicalTrials.gov ID: NCT07745062
What this study is testing
What is Systane PRO?
an investigational preservative‑free eye drop being studied as a potential treatment for dry eye disease is designed to lubricate and hydrate the ocular surface to reduce tear evaporation
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will find out whether Systane PRO preservative‑free works at least as well as Blink Triple Care preservative‑free in improving dry‑eye signs and symptoms over four weeks.
- Who it's for
- Adults who have been diagnosed with dry eye disease.
- What's involved
- You will be assigned to use one of the two eye‑drop products for four weeks and will have study visits to check your eye health and symptom scores.
- Time commitment
- The trial lasts about four weeks and includes a few clinic visits, such as a start‑up visit and a follow‑up at the end of the study.
- Phase 4: studies an already-approved treatment
- Time commitment: about 4 weeks
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Age: Adults ≥ 18 years.
- Diagnosis: Clinical diagnosis of mild to moderate dry eye disease in at least one eye with OSDI ≥ 13 to ≤ 32 at screening.
- OSDI ≥ 13 to ≤ 32 at screening.
- Objective evidence: NITBUT ≤ 10 seconds in the study eye(s) at screening.
- Ocular surface status: CFS ≤ grade 3 (Oxford or NEI scale) in the study eye(s).
You likely can't join if
- 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
See the full eligibility criteria
- Age: Adults ≥ 18 years.
- Diagnosis: Clinical diagnosis of mild to moderate dry eye disease in at least one eye with OSDI ≥ 13 to ≤ 32 at screening.
- OSDI ≥ 13 to ≤ 32 at screening.
- Objective evidence: NITBUT ≤ 10 seconds in the study eye(s) at screening.
- Ocular surface status: CFS ≤ grade 3 (Oxford or NEI scale) in the study eye(s).
- Stable medications: Systemic medications that may affect tear film must be stable ≥ 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.
- 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 treatment 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- La Jolla, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at La Jolla, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.