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NCT04268069 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye
A Phase 2 study, sponsored by ORA.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT04268069: Completed Phase 2 study, sponsored by ORA.
NCT04268069 is a Phase 2 study that has completed, run by ORA. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04268069, a Phase 2 study, has completed, sponsored by ORA.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.
Primary Outcome
An assessment of corneal fluorescein staining using the 0 \[none\] to 4 \[worst\] Ora Calibra Scale prior to and following exposure to a challenge in a controlled adverse environment (CAE)
Interventions
- DRUG Placebo Ophthalmic Solution
- DRUG PL9643 Ophthalmic Solution
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2020-02-14 |
| Est. Completion | 2020-10-05 |
| Phase | Phase 2 |
What the finished NCT04268069 record still lists
NCT04268069 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 2 interventions - of which Placebo Ophthalmic Solution is the first listed.
NCT04268069 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04268069 about?
NCT04268069 is a clinical study titled "Efficacy and Safety of PL9643 Ophthalmic Solution in Subjects With Dry Eye". Evaluation of safety and efficacy of PL9643 Ophthalmic Solution compared to placebo for the treatment of the signs and symptoms of dry eye.
What is the current status of trial NCT04268069?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2020-02-14. Estimated completion is 2020-10-05.
What interventions are being tested in trial NCT04268069?
The interventions under investigation include: Placebo Ophthalmic Solution (DRUG), PL9643 Ophthalmic Solution (DRUG).
Who is sponsoring clinical trial NCT04268069?
This trial is sponsored by ORA, which has 19 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04268069's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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