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

NCT07676084 | Recruiting Phase 4 FDA Drug

• 1 other identifier: BL-MA-CO01-ANDEYE-1401
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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)

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (1)

• Ocular Surface Disease Index (OSDI)

  14 days

Study Arms (5)

Blink® Triple Care Preservative-Free Lubricating Eye Drops (4 times daily [QID])

ACTIVE COMPARATOR

Drug: Preservative Free Polyethylene glycol 400 0.25%

Blink® Triple Care Preservative-Free Lubricating Eye Drops (2 times daily [BID])

ACTIVE COMPARATOR

Drug: Preservative Free Polyethylene glycol 400 0.25%

Propylene Glycol (0.6%)Systane® PRO Preservative-Free Lubricating Eye Drops (QID)

ACTIVE COMPARATOR

Drug: Propylene Glycol (0.6%)

Refresh Optive Mega-3® Preservative-Free Lubricating Eye Drops (QID)

ACTIVE COMPARATOR

Drug: Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5%

Systane® Original Preservative-Free Lubricating Eye Drops (QID)

ACTIVE COMPARATOR

Drug: Propylene Glycol (0.6%)

Interventions

Preservative Free Polyethylene glycol 400 0.25% DRUG

4 times daily \[QID\]

Blink® Triple Care Preservative-Free Lubricating Eye Drops (2 times daily [BID]); Blink® Triple Care Preservative-Free Lubricating Eye Drops (4 times daily [QID])

Propylene Glycol (0.6%) DRUG

Preservative Free Propylene Glycol (0.6%)

Propylene Glycol (0.6%)Systane® PRO Preservative-Free Lubricating Eye Drops (QID); Systane® Original Preservative-Free Lubricating Eye Drops (QID)

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

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

Refresh Optive Mega-3® Preservative-Free Lubricating Eye Drops (QID)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Andover Research Eye Institute: lead

Study Sites (1)

Andover Eye Associates

Andover, Massachusetts, 01810, United States

RECRUITING

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Propylene Glycol; Carboxymethylcellulose Sodium; Glycerol

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Propylene Glycols; Glycols; Alcohols; Organic Chemicals; Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates; Triose Sugar Alcohols; Sugar Alcohols

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2026
• First Posted: June 30, 2026
• Study Start: June 3, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 30, 2026

Record last verified: 2026-06

Locations

US (1)