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SBI-100 for Glaucoma

Phase 2

Waitlist Available

Research Sponsored by Skye Bioscience, Inc.

Eligibility Criteria Checklist

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

Must have

At least 18 years of age or greater at time of informed consent

Diagnosis of either primary open angle glaucoma (POAG) or ocular hypertension (OHT) in each eye

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline up to day 16

Awards & highlights

Study Summary

This trial tests a drug to see if it can safely lower eye pressure in glaucoma patients. Patients will use either the drug, a higher dose or a placebo for 14 days, with results compared at end.

Who is the study for?

This trial is for adults over 18 with primary open angle glaucoma or ocular hypertension in both eyes. They must be able to stop current eye pressure treatments safely, have a corneal thickness between 480 and 620 μm, and an eye pressure of 21-36 mmHg if untreated. Good vision (20/100 or better) is required.Check my eligibility

What is being tested?

The study tests SBI-100 Ophthalmic Emulsion's ability to lower eye pressure in glaucoma patients. Participants will receive either a low dose (0.5%), high dose (1.0%) of the emulsion, or a placebo twice daily for two weeks to compare effectiveness.See study design

What are the potential side effects?

Potential side effects may include discomfort at the drop site, redness, blurry vision, dry eyes or allergic reactions. Systemic side effects are possible but not specified here.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with glaucoma or high eye pressure in both eyes.

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My vision is 20/100 or better in both eyes.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline up to day 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline up to day 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline up to day 16 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Ocular and systemic safety

Ocular hypotensive efficacy

Secondary outcome measures

Application comfort

Ocular hypotensive efficacy at individual timepoints

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: SBI-100 Ophthalmic Emulsion, 1%Experimental Treatment1 Intervention

All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion

Group II: SBI-100 Ophthalmic Emulsion, 0.5%Experimental Treatment1 Intervention

All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion

Group III: SBI-100 Ophthalmic Emulsion PlaceboPlacebo Group1 Intervention

All patients enrolled into the study will be randomly assigned to an interventional treatment of 0.5% or 1.0% or Placebo, SBI-100 Ophthalmic Emulsion

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SBI-100 Ophthalmic Emulsion, 1.0%

2023

Completed Phase 2

~60

SBI-100 Ophthalmic Emulsion, 0.5%

2023

Completed Phase 2

~60

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Skye Bioscience, Inc.Lead Sponsor

Tu DiepStudy ChairSkye Bioscience, Inc.

Frequently Asked Questions

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

Is it still possible for participants to enroll in this investigation?

"Affirmative. Details on clinicaltrials.gov attest that this medical research project, which was first posted in November 9th 2023, is actively looking for participants. A total of 54 test subjects need to be enrolled from 3 distinct locations."

Answered by AI

Is the SBI-100 Ophthalmic Emulsion, 1% recognized by the FDA?

"Our internal team at Power has attributed a score of 2 to SBI-100 Ophthalmic Emulsion's safety, as this is only in its second trial phase and there are no efficacy measurements available."

Answered by AI

How many participants are anticipated to join this clinical trial?

"Affirmative. Clinicaltrials.gov has evidence that this clinical trial, which was initially listed on November 9th 2023, is actively recruiting patients for the study. 54 participants are required to be enrolled from 3 separate sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Phase 2, Placebo-Controlled, Study Assessing the Safety and Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Patients With Elevated Eye Pressure

2023. "Phase 2, Placebo-Controlled, Study Assessing the Safety and Ocular Efficacy of SBI-100 Ophthalmic Emulsion in Patients With Elevated Eye Pressure". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06144918.

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