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OTX-DED for Dry Eye Disease

Phase 2

Waitlist Available

Research Sponsored by Ocular Therapeutix, Inc.

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 change from baseline (cfb) at day 15

Awards & highlights

Study Summary

This trial studied the effectiveness & safety of a drug to treat Dry Eye Disease in the short term.

Who is the study for?

This trial is for people with Dry Eye Disease (DED) who have a certain level of eye dryness and redness, but not too severe. They should have normal eye pressure and haven't used artificial tears or contact lenses recently.Check my eligibility

What is being tested?

The trial tests OTX-DED's effectiveness in relieving DED symptoms short-term. It involves controlled insertion techniques compared to collagen punctal plugs, which are small devices inserted into tear ducts to block drainage.See study design

What are the potential side effects?

While the specific side effects of OTX-DED aren't listed here, similar treatments may cause temporary discomfort at the site of insertion, increased tearing, or irritation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline (cfb) at day 15

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change from baseline (cfb) at day 15

This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline (cfb) at day 15 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Severity of Eye Dryness Score (visual analogue scale (VAS))

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: OTX-DED 0.3mgExperimental Treatment1 Intervention

Group II: Controlled Insertion utilizing Collagen Punctal PlugExperimental Treatment1 Intervention

Group III: Collagen Punctal Plug (Full Insertion)Placebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

OTX-DED

2021

Completed Phase 2

~180

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Ocular Therapeutix, Inc.Lead Sponsor

53 Previous Clinical Trials

5,477 Total Patients Enrolled

Media Library

OTX-DED (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05814757 — Phase 2

Dry Eye Syndrome Research Study Groups: OTX-DED 0.3mg, Controlled Insertion utilizing Collagen Punctal Plug, Collagen Punctal Plug (Full Insertion)

Dry Eye Syndrome Clinical Trial 2023: OTX-DED Highlights & Side Effects. Trial Name: NCT05814757 — Phase 2

OTX-DED (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05814757 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the OTX-DED 0.3mg dosage been sanctioned by the Food and Drug Administration?

"Our analysis at Power has assigned OTX-DED 0.3mg a score of 2 based on the fact that it's in Phase 2; meaning there is some evidence indicating safety but no research proving its effectiveness yet."

Answered by AI

Is this study currently sourcing participants?

"The clinical trial database indicates that this protocol is not currently seeking participants. It was first published on April 1st 2023, and most recently modified 12 days later. For those still looking for a medical study to join, 148 other trials are presently recruiting patients."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)

2023. "OTX-DED for the Short-term Treatment of the Symptoms of Dry Eye Disease (DED)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05814757.

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