Inflammation Corneal, Pain, Postoperative
Conditions
Keywords
post-cataract,, inflammation, Pain, post-surgery, corticosteroid, anterior chamber cells, flares
Brief summary
The DX-216 trial is a randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle in the treatment of inflammation and pain following cataract surgery. The primary objective is to evaluate the efficacy and safety of OCS-01 compared to placebo and the secondary objective is to evaluate the optimal dosing frequency (once a day \[QD\] or twice a day \[BID\]).
Detailed description
This is a multi-center, randomized, double-masked, placebo (vehicle)-controlled study, designed to evaluate the efficacy and safety of OCS-01 ophthalmic suspension (QD versus BID) compared to placebo in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1:1 to receive OCS-01 QD, OCS-01 BID, or placebo BID. Subjects will dose 1 drop in the study eye BID for 14 days, beginning 1 day post-surgery in the operated eye. The study will last up to 24 days, including a follow-up visit at Visit 7 (Day 22 ± 2).
Interventions
DRUGOCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL
OCS-01 eye drops
DRUGPlacebo
Vehicle eye drops
Sponsors
Oculis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
For masking purposes, each dosing box and the pouches within it will be labeled either AM or PM. Dosing boxes and pouches will be labeled this way regardless of whether the product within the 2 boxes is the same (i.e. OCS-01 BID and placebo treatment arms) or different (i.e. OCS-01 QD).
Intervention model description
Randomized, double-masked, placebo (vehicle)-controlled study evaluating the efficacy and safety of two doses of OCS-01 compared to vehicle
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Provide written informed consent, approved by the appropriate ethics committee; 2. Be able to comply with the study requirements and visit schedule; 3. Be at least 18 years of age of either sex or any race; 4. Be planning to undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye; 5. Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 \[18 to 30 hours post-uncomplicated cataract surgery without vitreous loss\]); 6. Have a pin-hole visual acuity (VA) without any other correction \> 20 letters (approximately 20/400) in the operative eye and \> 35 letters (approximately 20/200) in the fellow eye as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart at Visit 1 (Day -1 to Day -28 \[prior to surgery\]); 7. Have a negative urine pregnancy test at Visit 1 (Day -1 to Day -28 \[prior to surgery\]),
Exclusion criteria
1. Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components; 2. Be monocular; 3. Have any intraocular inflammation (e.g. white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 \[prior to surgery\]) slit lamp examination; 4. Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye; 5. Use anti-inflammatory agents, analgesics/pain relievers (including opioids, narcotics, and other pain medications), or immunomodulating agents, systemically or in either eye, and/or use medications for benign prostatic hyperplasia (BPH), from the washout period through the duration of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0') | at Day 15 (visit 6) | Absence of anterior chamber cells as measured by slit beam with fluorescein. The anterior chamber cell count was recorded as the actual number of cells observed if ≤10 cells were seen, otherwise a range was reported. The observed anterior chamber cell count at Visit 6 was used and categorized for analysis as follows: * Absence of anterior chamber cells: anterior chamber cell count of 0 / Grade 0 * Presence of anterior chamber cells: anterior chamber cell count of 1 or more / Grade 1, 2, 3, or 4 |
| Number of Subjects With Absence of Ocular Pain (i.e. Score of '0') | at Day 4 (visit 4) | Absence of pain as assessed by Ocular Pain Grading Scale (Min 0, Max 10) in which 0 is no pain and 10 is the worst possible. Ocular pain was assessed by the patient at screening and at each follow-up visit, utilizing a numerical pain rating scale. Scores ranged from 0 to 10, where 0 = No Pain and 10 = Severe Pain, such that larger scores corresponded to higher levels of pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OCS-01 1.5% mg/mL QD eye drops
OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops
Placebo: Vehicle eye drops | 51 |
| OCS-01 1.5% mg/mL BID eye drops
OCS-01 - Dexamethasone Cyclodextrin Nanoparticle Ophthalmic Suspension 1.5% mg/mL: OCS-01 eye drops | 51 |
| Placebo (Vehicle) BID eye drops
Placebo: Vehicle eye drops | 51 |
| Total | 153 |
Baseline characteristics
| Characteristic | OCS-01 1.5% mg/mL BID | Placebo (Vehicle) BID | Total | OCS-01 1.5% mg/mL QD |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 29 Participants | 36 Participants | 103 Participants | 38 Participants |
| Age, Categorical Between 18 and 65 years | 22 Participants | 15 Participants | 50 Participants | 13 Participants |
| Age, Continuous | 65.8 years STANDARD_DEVIATION 6.59 | 67.5 years STANDARD_DEVIATION 8.41 | 67.1 years STANDARD_DEVIATION 7.34 | 68.0 years STANDARD_DEVIATION 6.86 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 4 Participants | 15 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants | 0 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 42 Participants | 47 Participants | 136 Participants | 47 Participants |
| Region of Enrollment United States | 51 participants | 51 participants | 153 participants | 51 participants |
| Sex: Female, Male Female | 36 Participants | 32 Participants | 101 Participants | 33 Participants |
| Sex: Female, Male Male | 15 Participants | 19 Participants | 52 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 51 | 1 / 51 |
| other Total, other adverse events | 17 / 51 | 10 / 51 | 20 / 51 |
| serious Total, serious adverse events | 0 / 51 | 1 / 51 | 1 / 51 |
Outcome results
Primary
Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0')
Absence of anterior chamber cells as measured by slit beam with fluorescein. The anterior chamber cell count was recorded as the actual number of cells observed if ≤10 cells were seen, otherwise a range was reported. The observed anterior chamber cell count at Visit 6 was used and categorized for analysis as follows: * Absence of anterior chamber cells: anterior chamber cell count of 0 / Grade 0 * Presence of anterior chamber cells: anterior chamber cell count of 1 or more / Grade 1, 2, 3, or 4
Time frame: at Day 15 (visit 6)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OCS-01 1.5% mg/mL QD | Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0') | 26 participants |
| OCS-01 1.5% mg/mL BID | Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0') | 34 participants |
| Placebo (Vehicle) BID | Number of Subjects With Absence of Anterior Chamber Cells (i.e. Score of '0') | 10 participants |
Primary
Number of Subjects With Absence of Ocular Pain (i.e. Score of '0')
Absence of pain as assessed by Ocular Pain Grading Scale (Min 0, Max 10) in which 0 is no pain and 10 is the worst possible. Ocular pain was assessed by the patient at screening and at each follow-up visit, utilizing a numerical pain rating scale. Scores ranged from 0 to 10, where 0 = No Pain and 10 = Severe Pain, such that larger scores corresponded to higher levels of pain.
Time frame: at Day 4 (visit 4)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| OCS-01 1.5% mg/mL QD | Number of Subjects With Absence of Ocular Pain (i.e. Score of '0') | 37 participants |
| OCS-01 1.5% mg/mL BID | Number of Subjects With Absence of Ocular Pain (i.e. Score of '0') | 32 participants |
| Placebo (Vehicle) BID | Number of Subjects With Absence of Ocular Pain (i.e. Score of '0') | 23 participants |