A Study to Evaluate Safety and Tolerability of QLS-101 in NTG
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ClinicalTrials.gov Identifier: NCT04857827 |
Recruitment Status :
Completed
First Posted : April 23, 2021
Last Update Posted : October 10, 2022
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Condition or disease | Intervention/treatment | Phase |
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Normal Tension Glaucoma | Drug: QLS-101 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 30 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
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. IPs will be provided in identical-appearing pouches to maintain masking. |
Primary Purpose: | Treatment |
Official Title: | A Randomized Active-controlled Study to Evaluate Safety and Tolerability of QLS-101 Versus Timolol Preservative Free Ophthalmic Solution in Subjects With Normal Tension Glaucoma |
Actual Study Start Date : | September 15, 2021 |
Actual Primary Completion Date : | August 26, 2022 |
Actual Study Completion Date : | August 26, 2022 |

Arm | Intervention/treatment |
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Experimental: QLS-101 ophthalmic solution 1.0%
Ophthalmic solution one time daily for 14 days (These patients will administer 2.0% QLS-101 for last 14 days of the study).
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Drug: QLS-101
Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing. |
Active Comparator: Timolol maleate PF 0.5% ophthalmic solution
Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.
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Drug: QLS-101
Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing. |
Experimental: QLS-101 ophthalmic solution 2%
Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing.
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Drug: QLS-101
Ophthalmic solution once daily dosing for 14 days followed by 14 days of twice daily dosing. |
- Ocular safety [ Time Frame: 86 days ]Number of participants with treatment-related adverse events will be monitored
- Ocular hypotensive efficacy [ Time Frame: 14 days ]Number of participants with intraocular pressure reduction from baseline will be calculated

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:
- Visual acuity +1.0 logMAR or better
- Willing to give informed consent
- Ability to washout from current intraocular pressure lowering medications -
Exclusion Criteria:
- All secondary glaucomas
- Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening)
- Refractive surgery
- Ocular infection or inflammation

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): NCT04857827
United States, South Dakota | |
Vance Thompson Vision | |
Sioux Falls, South Dakota, United States, 57108 |
Study Chair: | Qlaris Bio | Wellesley, MA |
Responsible Party: | Qlaris Bio, Inc. |
ClinicalTrials.gov Identifier: | NCT04857827 |
Other Study ID Numbers: |
QC-202 |
First Posted: | April 23, 2021 Key Record Dates |
Last Update Posted: | October 10, 2022 |
Last Verified: | August 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
low tension glaucoma glaucoma |
Glaucoma Low Tension Glaucoma Ocular Hypertension Eye Diseases Optic Nerve Diseases |