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Not yet recruitingNCT07845357ZolymbusUpdated Sep 28, 2026

Switching From Preserved Glaucoma Therapy to Preservative-Free ZOLYMBUS

A Phase 4 interventional study of preservative free ZOLYMBUS™ 0.01%. in Eye Drops Self-instillation, Glaucoma and Dry Eye, sponsored by Southern College of Optometry. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Southern College of Optometry · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Eye Drops Self-instillation
  • Glaucoma
  • Dry Eye

Keywords

  • dry eye
  • Glaucoma
  • preservative free
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Adults ≥18 years of age.
  2. Have a history of glaucoma or ocular hypertension.
  3. Currently being treated with a preserved topical glaucoma medication and currently have well-controlled intraocular pressure (≤ 21 mmHg).
  4. Currently using any type of prostaglandin analog glaucoma monotherapy.
  5. Have a history of dry eye disease for at least the past 6 months.
  6. 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
  7. Have corrected distance visual acuity of 20/40 or better.
  8. Willing to discontinue contact lens wear 24 hours prior to screening visit and throughout the study.

Exclusion criteria

Exclusion Criteria:

  1. Aqueous deficient dry eye disease as defined by Schirmer's test \<10 mm.
  2. Have a systemic health condition that is known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
  3. Have a history of ocular surgery within the past 12 months.
  4. Have a history of severe ocular trauma, active ocular infection or inflammation that is not dry eye related.
  5. Punctal plugs in place for \<3 months and/or Lacrifill in place for >5 months.
  6. Have ever used Accutane.
  7. Currently using other ocular medications, including topical anti-inflammatory drops at the time of enrollment.
  8. Are pregnant or breast feeding.
  9. Have had a physical meibomian gland treatment withing 1 month of enrollment.
  10. 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.
  11. 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.
04

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
40 participants (estimated)

Study arms

  • Experimental
    Zolymbus preservative free eye drop

    Participants will be given and instructed on how to use the product.

    Drug: preservative free ZOLYMBUS™ 0.01%.

Interventions

  • Drugpreservative 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: baseline 1 month

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT07845357
Lead sponsor
Southern College of Optometry
Responsible party
Sponsor
First posted
Sep 28, 2026
Start date
Oct 5, 2026 (estimated)
Primary completion
Feb 15, 2027 (estimated)
Completion
Feb 21, 2027 (estimated)
Last update
Sep 28, 2026

Study contacts

Chris Lievens, OD, PhD
Contact
clievens@sco.edu
901-481-5699
Quentin Franklin, BS, BA
Contact
QuentinFranklin@uab.edu
6592064188

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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