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QLS-101, 2.0% for Glaucoma

Phase 2
Waitlist Available
Led By Sharon Freedman, M.D.
Research Sponsored by Qlaris Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 28 days
Awards & highlights

Study Summary

This trialtests a new product to treat glaucoma and ocular hypertension in adolescents with Sturge-Weber Syndrome.

Eligible Conditions
  • Glaucoma
  • Ocular Hypertension
  • Sturge-Weber Syndrome

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days 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 safety
Systemic safety
Secondary outcome measures
Ocular hypotensive effectiveness

Side effects data

From 2015 Phase 4 trial • 157 Patients • NCT02003391
6%
Ocular hyperaemia
5%
Eye pruritus
2%
Nasopharyngitis
2%
Dry eye
1%
Acute tonsillitis
1%
Conjunctivitis allergic
1%
Eyelids pruritus
1%
Blepharal pigmentation
1%
Pharyngitis
1%
Eye irritation
1%
Cataract
1%
Arthritis
1%
Hypersensitivity
1%
Eye pain
1%
Ocular surface disease
100%
80%
60%
40%
20%
0%
Study treatment Arm
DuoTrav
Beta-blocker

Trial Design

1Treatment groups
Experimental Treatment
Group I: QLS-101, 2.0%Experimental Treatment1 Intervention
Qlaris' investigational product, QLS-101, 2.0% concentration, ocular administration (eye drop), given once daily in the morning to both eyes
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
QLS-101 ophthalmic solution, 2.0 %
2022
Completed Phase 2
~10

Find a Location

Who is running the clinical trial?

Qlaris Bio, Inc.Lead Sponsor
6 Previous Clinical Trials
345 Total Patients Enrolled
6 Trials studying Glaucoma
345 Patients Enrolled for Glaucoma
Sharon Freedman, M.D.Principal InvestigatorDuke Eye Center

Frequently Asked Questions

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

Has the FDA accepted QLS-101, 2.0% for use?

"Due to the lack of prior clinical data validating its efficacy, QLS-101, 2.0% received a score of two in terms of safety on our rating scale at Power. However, there is some evidence that supports its security profile."

Answered by AI

How many individuals are actively participating in this research endeavor?

"Affirmative. Clinicaltrials.gov reveals that recruitment is still open for this research project, which was first posted on November 23rd 2022 and most recently modified on the 29th of the same month. A total of 5 patients are being requested from one single site."

Answered by AI

Do I fulfill the criteria to join this experiment?

"Eligibility criteria for this research include being between the age of 12 and 19, having glaucoma or a suspicion thereof. The trial is seeking 5 volunteers in total."

Answered by AI

Are there still opportunities to join the current clinical trial?

"Data hosted on clinicaltrials.gov confirms that this medical research is presently recruiting participants. This trial was initially made available to the public on November 23rd 2022 and has been revised as of the 29th of November 2022."

Answered by AI

Is geriatric participation allowed in this experiment?

"According to the specified criteria, only individuals that span between 12 and 19 years of age may participate. Moreover, 398 trials are for people below 18 years old while 1186 clinical studies seek senior citizens over 65."

Answered by AI

Who else is applying?

What site did they apply to?
Duke Eye Center
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)
2022. "Safety and Tolerability Study of QLS-101 in Adolescents With Sturge-Weber Syndrome (SWS)-Related Glaucoma Due to Elevated Episcleral Venous Pressure (EVP)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05495269.
~1 spots leftby Apr 2025
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