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
Andover Research Eye Institute
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)
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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 exclusion criteria apply to either eye. 1. DED secondary to destruction of conjunctival goblet cells due to ocular trauma (eg, alkali burns) or ocular or system…
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%
Location
- Andover Eye AssociatesAndover, Massachusetts