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 |