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Ocular Hygiene Regimen for Cataracts and Dry Eye

Phase 4

Waitlist Available

Research Sponsored by Uptown Eye Specialists

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 2-5 days prior to surgery, post-operative month 1

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will assess the impact of using an omega-3 supplement and at-home lid wipes/eye drops before cataract surgery on inflammation, microbial load, tear osmolarity, and dry eye metrics.

Who is the study for?

This trial is for adults over 18 with any severity of dry eye syndrome who are undergoing cataract surgery. It's not for those unable to consent, with other eye conditions, systemic autoimmune or immune disorders, blood disorders, prior eye surgeries or treatments like ocular plugs.

What is being tested?

The study compares two pre-cataract surgery hygiene regimens: one includes omega-3 supplements and the other does not; both use lid wipes and cleansing drops. The effects on microbial load, inflammation markers, tear osmolarity, and dry eye symptoms will be measured.

What are the potential side effects?

Potential side effects may include irritation from eyelid wipes or cleansing drops and allergic reactions to omega-3 supplements. Discomfort during swabbing for microbial load assessment might occur.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 2-5 days prior to surgery, post-operative month 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 2-5 days prior to surgery, post-operative month 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 2-5 days prior to surgery, post-operative month 1 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

MMP-9

Microbial load

Tear osmolarity

Secondary study objectives

Bulbar redness

Canadian Dry Eye Assessment (CDEA) Questionnaire

Lipid layer

+2 more

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Omega-3Experimental Treatment4 Interventions

Participants in this arm will take oral omega-3 supplement for 4 weeks pre-operatively and 4 weeks post-operatively. They will also receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.

Group II: No Omega-3Active Control3 Interventions

Participants in this arm will not take oral omega-3 supplement. They will only receive the Zocular intervention in clinic and the lid wipe and Thealoz eyedrops at home.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Omega-3

2012

Completed Phase 4

~1760

Trehalose

2016

Completed Phase 3

~100