Eye Drops Self-instillationPhase 4ZolymbusNCT07845357
Switching From Preserved Glaucoma Therapy to Preservative-Free ZOLYMBUS
A Phase 4 study testing preservative free ZOLYMBUS™ 0.01%. in people with Eye Drops Self-instillation and Glaucoma, run by Southern College of Optometry.
Trial summary
Glaucoma is a large group of intraocular pressure-sensitive conditions that can cause progressive retinal ganglion cell (RGC) damage/loss and ultimately results in visual field loss that can produce irreversible blindness. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Eye Drops Self-instillation, Glaucoma, Dry Eye
- What is being tested?
- preservative free ZOLYMBUS™ 0.01%.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 5 Oct 2026to 21 Feb 2027
- 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
- Adults ≥18 years of age.
- Have a history of glaucoma or ocular hypertension.
- Currently being treated with a preserved topical glaucoma medication and currently have well-controlled intraocular pressure (≤ 21 mmHg).
- Currently using any type of prostaglandin analog glaucoma monotherapy.
- Have a history of dry eye disease for at least the past 6 months.
- Have dry eye disease as determined by the following: Eye Dryness VAS score of ≥40 plus OSDI ≥23 (moderate to severe) plus TBUT <10 seconds.8, 9
- Have corrected distance visual acuity of 20/40 or better.
- Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.
Who cannot join
- Aqueous deficient dry eye disease as defined by Schirmer's test <10 mm.
- Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- Have a history of ocular surgery within the past 12 months.
- Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
- Punctal plugs in place for <3 months and/or Lacrifill in place for >5 months.
- Have ever used Accutane.
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- Currently using other ocular medications, including topical anti-inflammatory drops at the time of enrollment.
- Are pregnant or breast feeding.
- Have had a physical meibomian gland treatment withing 1 month of enrollment.
- Initiated, discontinued, or changed dose of a systemic medication known to cause ocular drying (e.g., antihistamines or tricyclic antidepressants) within 14 days of the screening visit.
- Have a condition or be in a situation, which in the investigator's opinion, may put the participant at significant risk, may confound the results, or may significantly interfere with their study participation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Switching From Preserved Glaucoma Therapy to Preservative-Free ZOLYMBUS on Dry Eye Symptoms and Ocular Surface Health in Participants With Glaucoma or Ocular Hypertension
Glaucoma is a large group of intraocular pressure-sensitive conditions that can cause progressive retinal ganglion cell (RGC) damage/loss and ultimately results in visual field loss that can produce irreversible blindness. The literature suggests that about 3.5% of the world's population has glaucoma and that is expected to grow as life expectancy increases and individuals continue to live longer lives. The first line of defense against progressive glaucoma includes eye drops that lower intraocular pressure. Which unfortunately comes with side effects that can damage the ocular surface of the eye. Nearly 60% of those who use these persevered eye drops experience symptoms commonly associated with dry eye disease (DED). Such as burning, stinging and itching. Thus the purpose of this study is to determine the effectiveness of switching from a preserved topical glaucoma drop to a preservative free topical glaucoma drop in glaucoma patients who also have symptomatic dry eye disease.
Read the detailed description
Glaucoma is a large group of intraocular pressure-sensitive conditions that can cause progressive retinal ganglion cell (RGC) damage/loss and ultimately results in visual field loss that can produce irreversible blindness. The literature suggests that about 3.5% of the world's population has glaucoma and that is expected to grow as life expectancy increases and individuals continue to live longer lives. The first line of defense against progressive glaucoma includes eye drops that lower intraocular pressure. Which unfortunately comes with side effects that can damage the ocular surface of the eye. Nearly 60% of those who use these persevered eye drops experience symptoms commonly associated with dry eye disease (DED). Such as burning, stinging and itching. Thus the purpose of this study is to determine the effectiveness of switching from a preserved topical glaucoma drop to a preservative free topical glaucoma drop in glaucoma patients who also have symptomatic dry eye disease. This 3 month study aims to determine if patient comfort increases after switching to a preservative free eye drop.
- Conditions
- Eye Drops Self-instillation, Glaucoma, Dry Eye
- Being tested
- preservative free ZOLYMBUS™ 0.01%.
- Keywords
- dry eye, Glaucoma, preservative free
- Medical subject headings
- Glaucoma, Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preservative free ZOLYMBUS™ 0.01%.Drug
Participants will be given and instructed on how to use the preservative free eye drop and asked to report their ocular comfort.
| Study group | Role | What they receive |
|---|---|---|
| Zolymbus preservative free eye drop | Experimental | Participants will be given and instructed on how to use the product. Receives: Drug: preservative free ZOLYMBUS™ 0.01%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Eye Dryness (0-100 visual analog scale) scores at 3-month compared to baseline.
Participants will be asked to rate their eye dryness symptoms on a 0-100 scale with higher numbers indicating greater discomfort.
Measured: Baseline to 3 months
Secondary outcomes (1)
Change in Eye Dryness (0-100 visual analog scale) scores at 1-month compared to baseline.
Participants will be asked to gauge their eye dryness on the VAS scale 0-100 with higher scores indicating more discomfort.
Measured: baseline 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2026
- Study start5 Oct 2026 (estimated)
- Primary completion15 Feb 2027 (estimated)
- Study completion21 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye Drops Self-instillationStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Southern College of Optometry
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07845357
- Sponsor's protocol ID
- Zolymbus-IRB00006763
- Acronym
- Zolymbus
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided: An abstract describing the study will be submitted to ARVO 2027. A manuscript on this same topic will be submitted to Contact Lens \& Anterior Eye (or similar journal) after submitting the conference abstract.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Switching From Preserved Glaucoma Therapy to Preservative-Free ZOLYMBUS on Dry Eye Symptoms and Ocular Surface Health in Participants With Glaucoma or Ocular Hypertension
- ClinicalTrials.gov ID
- NCT07845357
- Acronym / sponsor ID
- Zolymbus / Zolymbus-IRB00006763
- Conditions
- Eye Drops Self-instillation, Glaucoma, Dry Eye
- Keywords
- dry eye, Glaucoma, preservative free
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Southern College of OptometryUniversity, hospital or other
- Study start
- 5 Oct 2026 (estimated)
- Primary completion
- 15 Feb 2027 (estimated)
- Study completion
- 21 Feb 2027 (estimated)
- First posted
- 28 Sep 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.
Glaucoma is a large group of intraocular pressure-sensitive conditions that can cause progressive retinal ganglion cell (RGC) damage/loss and ultimately results in visual field loss that can produce irreversible blindness. The literature suggests that about 3.5% of the world's population has glaucoma and that is expected to grow as life expectancy increases and individuals continue to live longer lives. The first line of defense against progressive glaucoma includes eye drops that lower intraocular pressure. Which unfortunately comes with side effects that can damage the ocular surface of the eye. Nearly 60% of those who use these persevered eye drops experience symptoms commonly associated with dry eye disease (DED). Such as burning, stinging and itching. Thus the purpose of this study is to determine the effectiveness of switching from a preserved topical glaucoma drop to a preservative free topical glaucoma drop in glaucoma patients who also have symptomatic dry eye disease.
Detailed description
Glaucoma is a large group of intraocular pressure-sensitive conditions that can cause progressive retinal ganglion cell (RGC) damage/loss and ultimately results in visual field loss that can produce irreversible blindness. The literature suggests that about 3.5% of the world's population has glaucoma and that is expected to grow as life expectancy increases and individuals continue to live longer lives. The first line of defense against progressive glaucoma includes eye drops that lower intraocular pressure. Which unfortunately comes with side effects that can damage the ocular surface of the eye. Nearly 60% of those who use these persevered eye drops experience symptoms commonly associated with dry eye disease (DED). Such as burning, stinging and itching. Thus the purpose of this study is to determine the effectiveness of switching from a preserved topical glaucoma drop to a preservative free topical glaucoma drop in glaucoma patients who also have symptomatic dry eye disease. This 3 month study aims to determine if patient comfort increases after switching to a preservative free eye drop.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Zolymbus preservative free eye drop | Experimental | Drug: preservative free ZOLYMBUS™ 0.01%.Participants will be given and instructed on how to use the product. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults ≥18 years of age.
- Have a history of glaucoma or ocular hypertension.
- Currently being treated with a preserved topical glaucoma medication and currently have well-controlled intraocular pressure (≤ 21 mmHg).
- Currently using any type of prostaglandin analog glaucoma monotherapy.
- Have a history of dry eye disease for at least the past 6 months.
Key exclusion criteria (11 listed)
- Aqueous deficient dry eye disease as defined by Schirmer's test <10 mm.
- Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- Have a history of ocular surgery within the past 12 months.
- Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
- Punctal plugs in place for <3 months and/or Lacrifill in place for >5 months.
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 ZOLYMBUS™ 0.01%.Participants will be given and instructed on how to use the preservative free eye drop and asked to report their ocular comfort. | Drug | Zolymbus preservative free eye drop |
Primary outcome
Change in Eye Dryness (0-100 visual analog scale) scores at 3-month compared to baseline.
Time frame: Baseline to 3 months
Participants will be asked to rate their eye dryness symptoms on a 0-100 scale with higher numbers indicating greater discomfort.
1 secondary outcome
Change in Eye Dryness (0-100 visual analog scale) scores at 1-month compared to baseline.
Time frame: baseline 1 month
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 28 Sep 2026.
- Individual participant dataSharing planned: Undecided. An abstract describing the study will be submitted to ARVO 2027. A manuscript on this same topic will be submitted to Contact Lens \& Anterior Eye (or similar journal) after submitting the conference abstract.
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing preservative free ZOLYMBUS™ 0.01%. in people with Eye Drops Self-instillation and Glaucoma, run by Southern College of Optometry.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Chris Lievens, OD, PhD (901-481-5699, clievens@sco.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Eye Dryness (0-100 visual analog scale) scores at 3-month compared to baseline. (time frame: Baseline to 3 months). 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 28 Sep 2026.