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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAndover Research Eye Institute

About this trial

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 criteria

Qualifiers

Be at least 18 years of age, male or female

Able to provide written voluntary informed consent

Able and willing to adhere to the protocol instructions, including participation in all study visits

Subject-reported symptoms or history consistent with dry eye for at least 6 months prior to Screening/Baseline (Visit 1)

Disqualifiers

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)

Any abnormal lid or corneal anatomy that would interfere with eyelid closure or create an irregular ocular tear film

Any active ocular infection, inflammation, or ocular allergy

Have undergone ocular surgery or laser refractive surgery within 9 months prior to Screening/Baseline (Visit 1)

Trial design

Treatments tested in this trial

  • Preservative Free Polyethylene glycol 400 0.25%
  • Propylene Glycol (0.6%)
  • Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5%

Treatment groups

60 Participants
are divided into 5 treatment groups

Sponsors and collaborators