Switching From Preserved Glaucoma Therapy to Preservative-Free ZOLYMBUS

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorSouthern College of Optometry

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Zolymbus preservative free eye dropExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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