A Phase 2 interventional study of Nepafenac PPDS and Placebo PPDS in Pain and Inflammation, sponsored by Mati Therapeutics Inc.. Completed at 3 sites in United States. Open to participants aged 22 Years to 99 Years. Per ClinicalTrials.gov, last updated 2021-10-12.
Sponsored by Mati Therapeutics Inc. · Phase 2, Interventional, and Treatment
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.
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:
Group A: A total of 50 study subjects (50 eyes) will have an N-PPDS inserted in the lower punctum of their scheduled surgical eye.
Group B: A total of 25 study subjects (25 eyes) will have a p-PPDS inserted in the lower punctum of their scheduled surgical eye.
All plugs will remain in the study subject's lower punctum for a period of 2 weeks following cataract surgery.
10,054 studies on the registry are indexed under Pain; 1,649 are open to participants now.
This study's enrollment of 56 is below the median of 66 across 8,493 interventional studies indexed under Pain.
Browse Pain studies →Mati Therapeutics Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.
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N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)
Combination Product: Nepafenac PPDS
p-PPDS (placebo Punctal Plug Delivery System) is an L-shaped, silicone punctal plug with a drug insert that contains no active ingredient (placebo).
Combination Product: Placebo PPDS
A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that contains nepafenac, a nonsteroidal anti-inflammatory drug.
A punctal plug delivery system (PPDS) is being developed as a device that can deliver a sustained release of a drug to a specific eye. The PPDS is made up of a medical grade silicone punctal plug which holds an insert (core) that does not contain nepafenac.
Assessment of Pain
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.
Time frame: day 14
Assessment of Anterior Chamber Cells
Anterior chamber cells are assessed using a scale of 0 - 4 with 0 representing no cells seen and 4 representing \>30 cells seen.
Time frame: day 14
Assessment of Flare
Anterior chamber flare is assessed using a scale of 0 - 4 with 0 representing no Tyndall effect and 4 representing Tyndall effect in anterior chamber is very intense
Time frame: day 14
| Milestone | Nepafenac PPDS | Placebo PPDS |
|---|---|---|
| Started | 38 | 18 |
| Completed | 34 | 14 |
| Not completed | 4 | 4 |
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.
| Participants | Nepafenac PPDS | Placebo PPDS |
|---|---|---|
| no pain | 30 | 13 |
| trace pain | 2 | 0 |
| mild pain | 2 | 1 |
| moderate pain | 0 | 0 |
| severe pain | 0 | 0 |
| intolerable pain | 0 | 0 |
Anterior chamber cells are assessed using a scale of 0 - 4 with 0 representing no cells seen and 4 representing \>30 cells seen.
| Participants | Nepafenac PPDS | Placebo PPDS |
|---|---|---|
| None: no cells seen | 22 | 7 |
| Trace: 1-5 cells seen | 7 | 3 |
| Mild: 6-15 cells seen | 5 | 4 |
| Moderate: 16-30 cells seen | 0 | 0 |
| Severe: >30 cells seen | 0 | 0 |
Anterior chamber flare is assessed using a scale of 0 - 4 with 0 representing no Tyndall effect and 4 representing Tyndall effect in anterior chamber is very intense
| Participants | Nepafenac PPDS | Placebo PPDS |
|---|---|---|
| None: No Tyndall effect | 29 | 10 |
| Trace: Tyndall effect barely discernible | 3 | 1 |
| Mild: Tyndall effect in anterior chamber is clearly visible | 2 | 3 |
| Moderate: Tyndall effect in anterior chamber is moderately intense | 0 | 0 |
| Severe: Tyndall effect in anterior chamber is very intense. The aqueous has a white milky appearance | 0 | 0 |
Collected over The Nepafenac PPDS or Placebo PPDS was inserted 1-2 days prior to surgery. Subjects were followed for 14 days (+/-2 days) post op. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nepafenac PPDS | 0/38 (0%) | 0/38 (0%) | 10/38 (26.3%) |
| Placebo PPDS | 0/18 (0%) | 0/18 (0%) | 3/18 (16.7%) |
| Event | Nepafenac PPDS | Placebo PPDS |
|---|---|---|
| elevated IOPEye disorders | 3/38 | 0/18 |
| Pain/irritation/inflammationEye disorders | 3/38 | 0/18 |
| iritisEye disorders | 2/38 | 1/18 |
| HeadacheNervous system disorders | 1/38 | 1/18 |
| posterior capsule ruptureEye disorders | 0/38 | 1/18 |
| Cavity, 3rd molarGeneral disorders | 1/38 | 0/18 |
| Age, Categorical(Participants) | Nepafenac PPDS | Placebo PPDS | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 14 | 6 | 20 |
| >=65 years | 24 | 12 | 36 |
| Age, Continuous(years) | Nepafenac PPDS | Placebo PPDS | Total |
|---|---|---|---|
| Mean | 67.2 ± 7.17 | 67.8 ± 7.64 | 67.4 ± 7.26 |
| Sex: Female, Male(Participants) | Nepafenac PPDS | Placebo PPDS | Total |
|---|---|---|---|
| Female | 19 | 11 | 30 |
| Male | 19 | 7 | 26 |
| Race (NIH/OMB)(Participants) | Nepafenac PPDS | Placebo PPDS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 2 | 2 |
| White | 38 | 15 | 53 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
| Region of Enrollment(participants) | Nepafenac PPDS | Placebo PPDS | Total |
|---|---|---|---|
| United States | 38 | 18 | 56 |
PDFs hosted by the registry, ClinicalTrials.gov.
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Mati Therapeutics Inc.