OTC lubricating eye drops for dry eye disease: tolerability and vision outcomes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized, single-center phase 4 study, adults with dry eye disease will use a preservative-free eye drop formulation containing polyethylene glycol, propylene glycol, carboxymethylcellulose, glycerin, and polysorbate 80 to assess tolerability, symptom changes, and visual function over the study period. The study will monitor safety and patient-reported outcomes, including ocular surface symptoms and quality of vision. Eligible participants must have persistent dry eye symptoms for at least 6 months and an OSDI score above 13, with several exclusion criteria to minimize confounding ocular conditions. The trial will be conducted at Andover Eye Associates under the lead sponsor Andover Research Eye Institute. Results could inform real-world use of OTC lubricants for DED management.

Why it matters

Who can join: the full rules

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 systemic condition (eg, Stevens-Johnson syndrome, ocular cicatricial pemphigoid, Vitamin A deficiency)
2. Any abnormal lid or corneal anatomy that would interfere with eyelid closure or create an irregular ocular tear film
3. Any active ocular infection, inflammation, or ocular allergy
4. Have undergone ocular surgery or laser refractive surgery within 9 months prior to Screening/Baseline (Visit 1)
5. Use of LipiFlow® procedure, intense pulse light procedure, or any kind of other procedure affecting meibomian glands within 6 months prior to Screening/Baseline (Visit 1)
6. Occlusion of the ocular puncta within 30 days prior to Screening/Baseline (Visit 1)
7. Have worn contact lenses within 3 days prior to Screening/Baseline (Visit 1) or planned wear during the study
8. Use of topical prescription products for dry eye, including topical ocular anti inflammatories (eg, cyclosporine, lifitegrast), corticosteroids, MIEBO® (perfluorohexyloctane ophthalmic solution), or TRYPTYR® (alcotremon ophthalmic solution) within 30 days prior to Screening/ Baseline (Visit 1)
9. Use of any eye drops (prescription or OTC, such as artificial tears or Lumify®) and/or TrueTear™ device (intranasal tear neurostimulator) within 24 hours prior to Screening/ Baseline (Visit 1)
10. Changes in any systemic medications known to impact tear production (eg, antihistamines, antidepressants, hormone replacement therapy, etc.) within 3 months prior to Screening/Baseline (Visit 1)
11. Have a serious or uncontrolled systemic disease (eg, diabetes, rheumatoid arthritis, lupus, hypertension, malignancy) that, in the opinion of the Investigator, will interfere with the study or interpretation of study results

Where it's running

• Andover Eye Associates
  Andover, Massachusetts, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.