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

A Randomized, Investigator-Masked, Single-Center Study Evaluating Tolerability, Symptomatic Improvement, and Visual Functional Outcomes With the Use of Over-the-Counter Lubricating Eye Drops in Subjects With Dry Eye Disease

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07676084

Enrollment

Registered

2026-06-30

Start date

2026-06-03

Completion date

2026-12-01

Last updated

2026-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye Disease (DED)

Brief summary

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)

Interventions

DRUGPreservative Free Polyethylene glycol 400 0.25%

4 times daily \[QID\]

DRUGPropylene Glycol (0.6%)

Preservative Free Propylene Glycol (0.6%)

DRUGCarboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5%

QID Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Be at least 18 years of age, male or female 2. Able to provide written voluntary informed consent 3. Able and willing to adhere to the protocol instructions, including participation in all study visits 4. Subject-reported symptoms or history consistent with dry eye for at least 6 months prior to Screening/Baseline (Visit 1) 5. Ocular Surface Disease Index (OSDI) score \>13

Exclusion criteria

Note: All ocular

Design outcomes

Primary

Measure	Time frame
Ocular Surface Disease Index (OSDI)	14 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 1, 2026