Trials / Unknown
UnknownNCT05245604
Evaluating the Efficacy and Safety of TJO-087 in Moderate to Severe Dry Eye Disease Patients
A Phase Ⅲ, Multicenter, Randomized, Double-blind, Active-controlled, Parallel Study of TJO-087 for Evaluating 32 Weeks Safety and Efficacy in Moderate to Severe Dry Eye Disease Patients
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 182 (estimated)
- Sponsor
- Taejoon Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 20 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this clinical study is to prove that the test drug (TJO-087) is not clinically inferior to the control drug after 32 weeks of administration to patients with suppressed tear production due to moderate or severe dry eye syndrome.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | TJO-087 | Cyclosporine ophthalmic nano-emulsion 0.08%, 1 drop once daily |
| DRUG | Cyclosporine ophthalmic solution 0.05% | Cyclosporine ophthalmic solution 0.05%, 1 drop twice/day |
Timeline
- Start date
- 2020-06-19
- Primary completion
- 2022-08-01
- Completion
- 2023-04-01
- First posted
- 2022-02-18
- Last updated
- 2022-02-18
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05245604. Inclusion in this directory is not an endorsement.