Recruiting

OTC Lubricating Eye Drops

Sponsor:

Andover Research Eye Institute

Code:

NCT07676084

Conditions

Dry Eye Disease (DED)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Preservative Free Polyethylene glycol 400 0.25%

Propylene Glycol (0.6%)

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

Study Details

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)

Study ID

NCT07676084

Start date

Jun 3, 2026

Status verified date

Jun, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Oct, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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

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

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

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

Interventions

Preservative Free Polyethylene glycol 400 0.25%

4 times daily \[QID\]

Propylene Glycol (0.6%)

Preservative Free Propylene Glycol (0.6%)

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 measure

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

Central Contacts and Locations

Locations

Andover Eye Associates

Recruiting

Andover, Massachusetts, United States, 01810

Contacts

More Information

Sponsor

Andover Research Eye Institute

Last update posted

Jun 30, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Andover Research Eye Institute on 2026-06-30.