Dry Eye Disease (DED)Phase 4NCT07676084
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
A Phase 4 study testing Preservative Free Polyethylene glycol 400 0.25%, Propylene Glycol (0.6%) and Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5% in people with Dry Eye Disease (DED), run by Andover Research Eye Institute at 1 site in United States.
Trial 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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Disease (DED)
- What is being tested?
- Preservative Free Polyethylene glycol 400 0.25%, Propylene Glycol (0.6%) and Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jun 2026to Dec 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Andover Eye Associates
Andover, Massachusetts, 01810
Medical Director, 9784750705, recruiting@andovereye.org
About this study
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
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)
- Being tested
- Preservative Free Polyethylene glycol 400 0.25%, Propylene Glycol (0.6%), Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5%
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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%
| Study group | Role | What they receive |
|---|---|---|
| Blink® Triple Care Preservative-Free Lubricating Eye Drops (4 times daily [QID]) | Active comparator | Not described Receives: Drug: Preservative Free Polyethylene glycol 400 0.25% |
| Blink® Triple Care Preservative-Free Lubricating Eye Drops (2 times daily [BID]) | Active comparator | Not described Receives: Drug: Preservative Free Polyethylene glycol 400 0.25% |
| Propylene Glycol (0.6%)Systane® PRO Preservative-Free Lubricating Eye Drops (QID) | Active comparator | Not described Receives: Drug: Propylene Glycol (0.6%) |
| Refresh Optive Mega-3® Preservative-Free Lubricating Eye Drops (QID) | Active comparator | Not described Receives: Drug: Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5% |
| Systane® Original Preservative-Free Lubricating Eye Drops (QID) | Active comparator | Not described Receives: Drug: Propylene Glycol (0.6%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ocular Surface Disease Index (OSDI)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2026
- Study start3 Jun 2026
- Primary completionOct 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye Disease (DED)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Andover Research Eye Institute
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07676084
- Sponsor's protocol ID
- BL-MA-CO01-ANDEYE-1401
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2026
- Last updated
- 30 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07676084
- Acronym / sponsor ID
- BL-MA-CO01-ANDEYE-1401
- Conditions
- Dry Eye Disease (DED)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Andover Research Eye InstituteIndustry (pharma, biotech, devices)
- Study start
- 3 Jun 2026 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 30 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 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%) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Preservative Free Polyethylene glycol 400 0.25%4 times daily [QID] | Drug | 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%)Preservative Free Propylene Glycol (0.6%) | Drug | 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%QID Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5% | Drug | Refresh Optive Mega-3® Preservative-Free Lubricating Eye Drops (QID) |
Primary outcome
Ocular Surface Disease Index (OSDI)
Time frame: 14 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Preservative Free Polyethylene glycol 400 0.25%, Propylene Glycol (0.6%) and Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5% in people with Dry Eye Disease (DED), run by Andover Research Eye Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ocular Surface Disease Index (OSDI) (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2026.