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

Detailed criteria

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

Drug
Preservative Free Polyethylene glycol 400 0.25%
4 times daily \[QID\]
Drug
Propylene Glycol (0.6%)
Preservative Free Propylene Glycol (0.6%)
Drug
Carboxymethylcellulose 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 Associates
Andover, Massachusetts
recruiting@andovereye.org 9784750705

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

Summary

Eligibility

Interventions

Location

Compensation

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Details

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