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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

ConditionDry Eye Disease (DED)
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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Preservative Free Polyethylene glycol 400 0.25%

    Drug

    4 times daily \[QID\]

  • Propylene Glycol (0.6%)

    Drug

    Preservative Free Propylene Glycol (0.6%)

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

    Drug

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

Treatment groups

60 Participants
are divided into 5 treatment groups
Group A: Blink® Triple Care Preservative-Free Lubricating Eye Drops (4 times daily [QID])Active comparator 1 intervention
Group B: Blink® Triple Care Preservative-Free Lubricating Eye Drops (2 times daily [BID])Active comparator 1 intervention
Group C: Propylene Glycol (0.6%)Systane® PRO Preservative-Free Lubricating Eye Drops (QID)Active comparator 1 intervention
Group D: Refresh Optive Mega-3® Preservative-Free Lubricating Eye Drops (QID)Active comparator 1 intervention
Group E: Systane® Original Preservative-Free Lubricating Eye Drops (QID)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Ocular Surface Disease Index (OSDI)

Time frame
14 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Andover Research Eye Institute

Lead sponsor

Source ClinicalTrials.gov
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