Normal Tension Glaucoma (NTG) Clinical Trial
Official title:
A Randomized Active-controlled Study to Evaluate Safety and Tolerability of QLS-101 Versus Timolol Preservative Free (PF) Ophthalmic Solution in Subjects With Normal Tension Glaucoma (NTG)
Verified date | March 2023 |
Source | Qlaris Bio, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A randomized active-controlled multi-site double-masked 28 day study to evaluate the safety and tolerability of QLS-101 versus timolol maleate Preservative Free (PF) 0.5% ophthalmic solution in subjects with normal tension glaucoma
Status | Completed |
Enrollment | 30 |
Est. completion date | August 26, 2022 |
Est. primary completion date | August 26, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Visual acuity +1.0 logMAR or better 2. Willing to give informed consent 3. Ability to washout from current intraocular pressure lowering medications - Exclusion Criteria: 1. All secondary glaucomas 2. Previous glaucoma intraocular or laser surgery (selective laser trabeculoplasty permitted when done 18 months or longer from Screening) 3. Refractive surgery 4. Ocular infection or inflammation |
Country | Name | City | State |
---|---|---|---|
United States | Vance Thompson Vision | Sioux Falls | South Dakota |
Lead Sponsor | Collaborator |
---|---|
Qlaris Bio, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Ocular safety | Number of participants with treatment-related adverse events will be monitored | 86 days | |
Secondary | Ocular hypotensive efficacy | Number of participants with intraocular pressure reduction from baseline will be calculated | 14 days |