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Clinical trial

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)

ID
Name
QC-202
Description
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
Trial arms
Trial start
2021-09-15
Estimated PCD
2022-08-26
Trial end
2022-08-26
Status
Completed
Phase
Early phase I
Treatment
QLS-101
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Arms:
QLS-101 ophthalmic solution 1.0%, QLS-101 ophthalmic solution 2.0%
Other names:
QLS-101 ophthalmic solution
Timolol maleate PF 0.5% ophthalmic solution
Ophthalmic solution QD OU dosing for 14 days followed by 14 days BID OU dosing.
Arms:
Timolol maleate PF 0.5% ophthalmic solution
Other names:
Timolol
Size
30
Primary endpoint
Ocular safety
86 days
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'Study subjects, Investigators and their staff, and Sponsor personnel involved with the conduct and monitoring of the study will be masked to the investigational product (IP) identity until after the final database is locked. IPs will be provided in identical-appearing pouches to maintain masking.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2023-04-03

1 organization

2 products

1 indication

Organization
Qlaris Bio
Product
Timolol maleate PF 0.5%
Indication
Glaucoma
Product
QLS-101