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

Purpose

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)

Condition

  • Dry Eye Disease (DED)

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 4
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Blink® Triple Care Preservative-Free Lubricating Eye Drops (4 times daily [QID])
  • Drug: Preservative Free Polyethylene glycol 400 0.25%
    4 times daily [QID]
Active Comparator
Blink® Triple Care Preservative-Free Lubricating Eye Drops (2 times daily [BID])
  • Drug: Preservative Free Polyethylene glycol 400 0.25%
    4 times daily [QID]
Active Comparator
Propylene Glycol (0.6%)Systane® PRO Preservative-Free Lubricating Eye Drops (QID)
  • Drug: Propylene Glycol (0.6%)
    Preservative Free Propylene Glycol (0.6%)
Active Comparator
Refresh Optive Mega-3® Preservative-Free Lubricating Eye Drops (QID)
  • Drug: Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5%
    QID Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5%
Active Comparator
Systane® Original Preservative-Free Lubricating Eye Drops (QID)
  • Drug: Propylene Glycol (0.6%)
    Preservative Free Propylene Glycol (0.6%)

Recruiting Locations

Andover Eye Associates
Andover, Massachusetts 01810
Contact:
Medical Director
9784750705
recruiting@andovereye.org

More Details

Status
Recruiting
Sponsor
Andover Research Eye Institute

Study Contact