At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 469 enrolled
Drug / intervention
Aceclidine+Brimonidine combination ophthalmic solution +2 moredrug
Likely dose
Not stated in record
Key inclusion· 5
- ✓Age 45-75 years at Visit 1
- ✓Refractive error: +1.00 to -4.00 D sphere (minus cylinder) in both eyes, with spherical equivalent no worse than -4.00 D MRSE
- ✓≤2.00 D of cylinder (minus cylinder) in both eyes
- ✓Confirmed presbyopia at Visit 1
Key exclusion· 7
- ✕Known contraindications or sensitivity to study medications or their components
- ✕Active ocular infection (bacterial, viral, or fungal) at Visit 1 or Visit 2
- ✕Positive history of ocular herpetic infection or preauricular lymphadenopathy
- ✕Ongoing active ocular inflammation in either eye
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multi-Center, Double-Masked Phase 3 Evaluation of the Safety and Efficacy of LNZ101 for the Treatment of Presbyopia
In Brief
A Phase 3 clinical trial evaluating Aceclidine+Brimonidine combination ophthalmic solution, Aceclidine ophthalmic solution, and 1 other intervention for Presbyopia and 3 related conditions. Completed, enrolled 469 participants across 25 sites.
Detailed Summary
Phase 3 study to evaluate the safety and effectiveness of LNZ100 \& LNZ101 for the treatment of Presbyopia.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPresbyopia, Refractive Error, Eye Diseases, Near Vision
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2023202420252026
First PostedDec 2022
Enrollment StartDec 2022
Primary CompletionDec 2023
Study CompletionJan 2024
TodayJul 2026
First PostedDec 19, 2022
Enrollment StartDec 19, 2022
Primary CompletionDec 15, 2023
Study CompletionJan 25, 2024
TodayJul 2, 2026
Enrollment to primary: 12 monthsPosted 3.5 years ago
Interventions
Aceclidine+Brimonidine combination ophthalmic solutiondrug
LNZ101 (Aceclidine/Brimonidine) ophthalmic solution
Aceclidine ophthalmic solutiondrug
LNZ100 Aceclidine ophthalmic solution
Brimonidinedrug
Brimonidine ophthalmic solution