Qlaris Phase 2 Study of QLS-111 in POAG and/or OHT Patients
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ClinicalTrials.gov Identifier: NCT06016972 |
Recruitment Status :
Recruiting
First Posted : August 30, 2023
Last Update Posted : March 19, 2024
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Condition or disease | Intervention/treatment | Phase |
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Primary Open Angle Glaucoma (POAG) Primary Open Angle Glaucoma of Both Eyes Primary Open-Angle Glaucoma, Unspecified Eye Ocular Hypertension (OHT) | Drug: Experimental: QLS-111 ophthalmic solution, (0.015%) Drug: Experimental: QLS-111 ophthalmic solution, (0.03%) Drug: Experimental: QLS-111 ophthalmic solution, (0.075%) Other: QLS-111 ophthalmic vehicle solution | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Multi site double masked, vehicle-controlled, randomized, prospective parallel study of 7 days' QAM dosing, followed by 7 days' QPM dosing, and 7 days' BID dosing (7 days of dosing per regimen [21-day treatment period])of an investigational product (IP), QLS-111 or vehicle. Both eyes (OU) will be dosed. |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the IP identity until after the final database is locked. IP will be provided in identical packaging. Unmasked statistician preparing the masked randomization schedule. |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Multi-site, Double-masked Study Evaluating the Safety and Tolerability of QLS-111 vs Vehicle in Primary Open-angle Glaucoma or Ocular Hypertension Patients |
Actual Study Start Date : | March 15, 2024 |
Estimated Primary Completion Date : | September 5, 2024 |
Estimated Study Completion Date : | September 5, 2024 |
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Arm | Intervention/treatment |
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Experimental: QLS-111 ophthalmic solution
Qlaris' investigational product, QLS-111 ophthalmic solution, provided in 3 concentrations for this study (0.015%, 0.03%. and 0.075%), single use vials, masked, and preservative free (PF).
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Drug: Experimental: QLS-111 ophthalmic solution, (0.015%)
QLS-111 ophthalmic solution, (0.015%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
Other Name: QLS-111 Drug: Experimental: QLS-111 ophthalmic solution, (0.03%) QLS-111 ophthalmic solution, (0.03%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
Other Name: QLS-111 Drug: Experimental: QLS-111 ophthalmic solution, (0.075%) QLS-111 ophthalmic solution, (0.075%) applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
Other Name: QLS-111 |
Placebo Comparator: QLS-111 ophthalmic vehicle solution
Inactive control (0.00%). QLS-111 ophthalmic vehicle solution, single use vials, masked, PF.
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Other: QLS-111 ophthalmic vehicle solution
Vehicle ophthalmic solution applied QAM OU for 7 days followed by QPM dosing OU for 7 days, and BID OU dosing for 7 days to constitute a 21-day study treatment period. All IP for this study will be supplied masked in PF single use vials.
Other Names:
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- Incidence of ocular symptoms and ocular treatment-emergent adverse events (TEAEs) [ Time Frame: 21 days ]Ocular safety and tolerability: adverse events (AEs)
- Clinically significant change in visual acuity [ Time Frame: 21 days ]Ocular safety and tolerability: visual acuity
- Clinically significant change in findings on slit lamp exam [ Time Frame: 21 days ]Ocular safety and tolerability: slit lamp
- Clinically significant change in findings on fundus exam [ Time Frame: 21 days ]Ocular safety and tolerability: fundus
- Incidence of systemic TEAEs [ Time Frame: 21 days ]Systemic safety and tolerability: AEs
- Clinically significant changes in blood pressure (BP) [ Time Frame: 21 days ]Systemic safety and tolerability: vital signs
- Clinically significant changes in heart rate (HR) [ Time Frame: 21 days ]Systemic safety and tolerability: vital signs
- Change from baseline (CFB) of diurnal intraocular pressure (IOP) in the study eye [ Time Frame: 21 days ]Ocular hypotensive efficacy: diurnal IOP CFB
- CFB in IOP at various timepoints in the study eye [ Time Frame: up to 21 days ]Ocular hypotensive efficacy: CFB for multiple timepoints throughout day
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 18 years or older
- Able to provide written acknowledgement of giving informed consent
- Best corrected visual acuity (BCVA) 20/200 or better Bilateral POAG or OHT with documented historic IOP value(s) ≥24 mmHg, in either eye
- Post-washout IOP ≥22 mmHg in morning on Visits 2 and 3 and ≥18 mmHg at noon on Visit 2
Exclusion Criteria:
- IOP >34 mmHg
- Severe glaucomatous damage that would preclude safe washout of prescribed ocular hypotensive medications
- Previous glaucoma surgery, certain procedures (trabeculotomy, shunt/tubes, cyclodestructive procedure) (selective laser trabeculoplasty (SLT) allowed if done no earlier than 1 year from study, some minimally invasive glaucoma surgeries are allowed if done no earlier than 1 year from study)
- Ocular trauma, ocular infections, ocular inflammation, herpes simplex keratitis of eye
- Use of other ophthalmic concomitant medications during the study
- Uncontrolled hypertension or hypotension
- Significant systemic or psychiatric disease
- Participation in other investigational trial 30 days prior to screening or previous enrollment and treatment with Qlaris investigational product
- Pregnant or lactating
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06016972
Contact: Lisa Brandano | 9789302103 | lbrandano@qlaris.bio | |
Contact: Daniel DeWalt | ddewalt@qlaris.bio |
United States, Georgia | |
Coastal Research Associates, LLC | Recruiting |
Roswell, Georgia, United States, 30076 |
Study Director: | Lisa Brandano | Qlaris Bio, Inc. |
Responsible Party: | Qlaris Bio, Inc. |
ClinicalTrials.gov Identifier: | NCT06016972 |
Other Study ID Numbers: |
QC-111-201 Osprey ( Other Identifier: Qlaris Bio, Inc. ) |
First Posted: | August 30, 2023 Key Record Dates |
Last Update Posted: | March 19, 2024 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Qlaris POAG OHT |
IOP Glaucoma Osprey |
Glaucoma Glaucoma, Open-Angle Ocular Hypertension Hypertension Vascular Diseases |
Cardiovascular Diseases Eye Diseases Pharmaceutical Solutions Ophthalmic Solutions |