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Recruiting NCT07676084

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

Phase IV Interventional Dry Eye Disease (DED)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Preservative Free Polyethylene glycol 400 0.25%, Propylene Glycol (0.6%), Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5%.
Who it may be relevant to
Registry conditions: Dry Eye Disease (DED). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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)

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%

Primary outcome measures

  • Ocular Surface Disease Index (OSDI) [Time frame: 14 days]

Eligibility criteria

Inclusion criteria

  • 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)
  • Ocular Surface Disease Index (OSDI) score >13

Exclusion criteria

Note: All ocular exclusion criteria apply to either eye.

  • 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)
  • 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)
  • Occlusion of the ocular puncta within 30 days prior to Screening/Baseline (Visit 1)
  • Have worn contact lenses within 3 days prior to Screening/Baseline (Visit 1) or planned wear during the study
  • 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)
  • 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)
  • 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)
  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 1 center
  • Andover Eye Associates — Andover

Identifiers

NCT: NCT07676084 · BL-MA-CO01-ANDEYE-1401

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗