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NCT03496467 · ClinicalTrials.gov registry record · Phase 2
Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract
A Phase 2 study of Pain and Inflammation, sponsored by Mati Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 56
- Enrollment target
- 3
- Study locations
NCT03496467: Completed Phase 2 study of Pain and Inflammation, sponsored by Mati Therapeutics.
NCT03496467 is a Phase 2 study of Pain and Inflammation that has completed, run by Mati Therapeutics. The registered enrollment target is 56 participants, below the 304-participant average among 374 other Pain trials with a reported enrollment target (82% lower). The trial reports 3 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03496467, a Phase 2 study of Pain and Inflammation, has completed, sponsored by Mati Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 56 participants
- Enrollment target
- 3
- Study locations
Study Summary
This is a Phase 2, multi-center, randomized, parallel-arm, double-masked, placebo-controlled study. One (1) to 2 days prior to their scheduled cataract surgery, each study subject will be randomized (2:1) in to one of two treatment groups: N-PPDS or p-PPDS, which are inserted in the lower punctum of the subject's scheduled surgical eye. All plugs will remain in the study subject's lower punctum for a period of 2 weeks following cataract surgery.
Primary Outcome
Assessment of pain in subjects as measured by a scale of 0 - 5. Post-op pain scale: 0 represents absence of pain and 5 represents a definite, continuous unbearable ocular or periocular pain.
Conditions Studied
Interventions
- COMBINATION_PRODUCT Nepafenac PPDS
- COMBINATION_PRODUCT Placebo PPDS
Study Locations (3)
Kentucky
- Cincinnati Eye Institute-Edgewood - Edgewood
New York
- Ophthalmic Consultants of Long Island - Garden City
South Carolina
- Kerry Solomon, MD - Mt. Pleasant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 56 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2018-12-17 |
| Phase | Phase 2 |
What the finished NCT03496467 record still lists
NCT03496467 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 304-participant average among 374 other Pain trials with a reported enrollment target (82% lower).
The record links to 2 conditions, with Pain appearing as the primary indexed condition, and to 2 interventions - of which Nepafenac PPDS is the first listed.
NCT03496467 reports a single indexed study location in Kentucky, New York, South Carolina.
Frequently Asked Questions
What is clinical trial NCT03496467 about?
NCT03496467 is a clinical study titled "Safety/Efficacy of Nepafenac Punctal Plug Delivery System Compared to Placebo to Control Ocular Pain/Inflammation After Cataract". This is a Phase 2, multi-center, randomized, parallel-arm, double-masked, placebo-controlled study. One (1) to 2 days prior to their scheduled cataract surgery, each study subject will be randomized (2:1) in to one of two treatment groups: N-PPDS or p-PPDS, which are inserted in the lower punctum of...
What is the current status of trial NCT03496467?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 56 participants. The study started on 2018-03-05. Estimated completion is 2018-12-17.
What conditions does trial NCT03496467 study?
This clinical trial studies the following conditions: Pain, Inflammation.
What interventions are being tested in trial NCT03496467?
The interventions under investigation include: Nepafenac PPDS (COMBINATION_PRODUCT), Placebo PPDS (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03496467?
This trial is sponsored by Mati Therapeutics, which has 12 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03496467 being conducted?
This trial has 3 study locations across Kentucky, New York, South Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT03496467's enrollment target sits among peer trials
56 245th of 374 higher than 127 of 374 other Pain trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pain 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.
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