Inflammation, Pain
Conditions
Keywords
Treatment of pain and inflammation after Cataract Surgery
Brief 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.
Detailed description
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.
Interventions
COMBINATION_PRODUCTNepafenac 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.
COMBINATION_PRODUCTPlacebo 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 does not contain nepafenac.
Sponsors
Mati Therapeutics Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. A male or female subject in good general health, ≥ 22 years of age at the time of the screening visit 2. A subject with a cataract for which routine phacoemulsification extraction and implantation of an intraocular lens has been planned 3. A subject has a lower puncta that can be dilated to 1.0 mm in their scheduled surgical eye
Exclusion criteria
1. A subject with a history of complications, adverse events, trauma or disease in the nasolacrimal area, whether or not it was due to punctal plug wear, including but not limited to dacryocystitis, inflammation or canaliculitis in either eye 2. A subject with structural lid abnormalities (e.g., ectropion, entropion) in their schedule surgical eye 3. A subject with a puncta \>0.9 mm prior to dilation in their scheduled surgical eye 4. A subject with any signs of intraocular inflammation (cells/flare) in either eye at the screening visit 5. A subject with a known sensitivity to nepafenac or any inactive ingredient of the punctum plug, silicone, fluorescein, topical anesthetic, or any other products required for study procedures or cataract surgery 6. A subject with a history of chronic/recurrent inflammatory eye disease (e.g., scleritis, uveitis, herpes keratitis) in either eye
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Pain | day 14 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Anterior Chamber Cells | day 14 | Anterior chamber cells are assessed using a scale of 0 - 4 with 0 representing no cells seen and 4 representing \>30 cells seen. |
| Assessment of Flare | day 14 | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nepafenac PPDS N-PPDS (Nepafenac Punctal Plug Deliver System) is an L-shaped, silicone punctal plug with a drug eluting core that contains nepafenac (active)
Nepafenac 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. | 38 |
| Placebo 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).
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 does not contain nepafenac. | 18 |
| Total | 56 |
Baseline characteristics
| Characteristic | Placebo PPDS | Total | Nepafenac PPDS |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 12 Participants | 36 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 20 Participants | 14 Participants |
| Age, Continuous | 67.8 years STANDARD_DEVIATION 7.64 | 67.4 years STANDARD_DEVIATION 7.26 | 67.2 years STANDARD_DEVIATION 7.17 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 53 Participants | 38 Participants |
| Region of Enrollment United States | 18 participants | 56 participants | 38 participants |
| Sex: Female, Male Female | 11 Participants | 30 Participants | 19 Participants |
| Sex: Female, Male Male | 7 Participants | 26 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 18 |
| other Total, other adverse events | 10 / 38 | 3 / 18 |
| serious Total, serious adverse events | 0 / 38 | 0 / 18 |
Outcome results
Primary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nepafenac PPDS | Assessment of Pain | no pain | 30 Participants |
| Nepafenac PPDS | Assessment of Pain | trace pain | 2 Participants |
| Nepafenac PPDS | Assessment of Pain | mild pain | 2 Participants |
| Nepafenac PPDS | Assessment of Pain | moderate pain | 0 Participants |
| Nepafenac PPDS | Assessment of Pain | severe pain | 0 Participants |
| Nepafenac PPDS | Assessment of Pain | intolerable pain | 0 Participants |
| Placebo PPDS | Assessment of Pain | severe pain | 0 Participants |
| Placebo PPDS | Assessment of Pain | no pain | 13 Participants |
| Placebo PPDS | Assessment of Pain | moderate pain | 0 Participants |
| Placebo PPDS | Assessment of Pain | trace pain | 0 Participants |
| Placebo PPDS | Assessment of Pain | intolerable pain | 0 Participants |
| Placebo PPDS | Assessment of Pain | mild pain | 1 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nepafenac PPDS | Assessment of Anterior Chamber Cells | Trace: 1-5 cells seen | 7 Participants |
| Nepafenac PPDS | Assessment of Anterior Chamber Cells | Moderate: 16-30 cells seen | 0 Participants |
| Nepafenac PPDS | Assessment of Anterior Chamber Cells | Mild: 6-15 cells seen | 5 Participants |
| Nepafenac PPDS | Assessment of Anterior Chamber Cells | Severe: >30 cells seen | 0 Participants |
| Nepafenac PPDS | Assessment of Anterior Chamber Cells | None: no cells seen | 22 Participants |
| Placebo PPDS | Assessment of Anterior Chamber Cells | Severe: >30 cells seen | 0 Participants |
| Placebo PPDS | Assessment of Anterior Chamber Cells | None: no cells seen | 7 Participants |
| Placebo PPDS | Assessment of Anterior Chamber Cells | Trace: 1-5 cells seen | 3 Participants |
| Placebo PPDS | Assessment of Anterior Chamber Cells | Mild: 6-15 cells seen | 4 Participants |
| Placebo PPDS | Assessment of Anterior Chamber Cells | Moderate: 16-30 cells seen | 0 Participants |
Secondary
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
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nepafenac PPDS | Assessment of Flare | Trace: Tyndall effect barely discernible | 3 Participants |
| Nepafenac PPDS | Assessment of Flare | Moderate: Tyndall effect in anterior chamber is moderately intense | 0 Participants |
| Nepafenac PPDS | Assessment of Flare | Mild: Tyndall effect in anterior chamber is clearly visible | 2 Participants |
| Nepafenac PPDS | Assessment of Flare | Severe: Tyndall effect in anterior chamber is very intense. The aqueous has a white milky appearance | 0 Participants |
| Nepafenac PPDS | Assessment of Flare | None: No Tyndall effect | 29 Participants |
| Placebo PPDS | Assessment of Flare | Severe: Tyndall effect in anterior chamber is very intense. The aqueous has a white milky appearance | 0 Participants |
| Placebo PPDS | Assessment of Flare | None: No Tyndall effect | 10 Participants |
| Placebo PPDS | Assessment of Flare | Trace: Tyndall effect barely discernible | 1 Participants |
| Placebo PPDS | Assessment of Flare | Mild: Tyndall effect in anterior chamber is clearly visible | 3 Participants |
| Placebo PPDS | Assessment of Flare | Moderate: Tyndall effect in anterior chamber is moderately intense | 0 Participants |