Randomized Single Center Study to Evaluate Tolerability, Symptoms, and Visual Functional Outcomes With the Use of OTC Lubricating Eye Drops in Subjects With Dry Eye Disease

Part of paid clinical trials in Andover, Massachusetts.

Sponsor
Andover Research Eye Institute
Study ID
NCT07676084
Phase
PHASE4
Status
Recruiting

Conditions

  • Dry Eye Disease (DED)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Preservative Free Polyethylene glycol 400 0.25% — DRUG
    4 times daily \[QID\]
  • Propylene Glycol (0.6%) — DRUG
    Preservative Free Propylene Glycol (0.6%)
  • Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5% — DRUG
    QID Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5%

Study Details

A study to evaluate the effect of over- the- counter (OTC) lubricating eye drops on tolerability, symptoms and visual outcomes in patients with dry eye disease (DED)

Key Dates

Start date
Jun 3, 2026
Status verified
Jun 2026
Primary completion
Oct 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Blink® Triple Care Preservative-Free Lubricating Eye Drops (4 times daily [QID])
  • Active Comparator: Blink® Triple Care Preservative-Free Lubricating Eye Drops (2 times daily [BID])
  • Active Comparator: Propylene Glycol (0.6%)Systane® PRO Preservative-Free Lubricating Eye Drops (QID)
  • Active Comparator: Refresh Optive Mega-3® Preservative-Free Lubricating Eye Drops (QID)
  • Active Comparator: Systane® Original Preservative-Free Lubricating Eye Drops (QID)

Primary Outcome Measure

Ocular Surface Disease Index (OSDI) [ Time Frame: 14 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
Andover Eye AssociatesAndoverMassachusetts01810
Medical Director
9784750705

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