Cataract
Conditions
Keywords
PCIOL, CCI CE
Brief summary
To assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
Detailed description
This is a randomized, controlled study to evaluate the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert in the operating room following cataract surgery/intraocular lens implant (IOL) with or without iStent/Hydrus/Goniotomy when placed in the lower punctum compared to the upper punctum.
Interventions
(dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery.
Sponsors
Ocular Therapeutix, Inc.
Iworks Laser and Vision Center
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Each subject's participation is expected to last for approximately 1 month and will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit), Operative Visit/Insertion Day (Day 0), Day 1, Day 8, Day 14 and Day 30.
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects will be eligible for study participation if they: 1. Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes with or without iStent/Hydrus/Goniotomy. 2. Are willing and able to comply with clinic visits and study related procedures. 3. Are willing and able to sign the informed consent form. 4. Not pregnant.
Exclusion criteria
Subjects are not eligible for study participation if they: 1. Are currently being treated with corticosteroid implant (i.e. Ozurdex). 2. Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye. 3. Have a history of complete punctal occlusion in one or both punctum. 4. Currently use topical ophthalmic steroid medications. 5. Are unwilling or unable to comply with the study protocol. 6. Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment. 7. Have active infectious systemic disease. 8. Have active infectious ocular or extraocular disease. 9. Have unobstructed nasolacrimal duct in the study eye(s) (dacrocystitis). 10. Have known hypersensitivity to dexamethasone or are a known steroid responder. 11. Have a history of ocular inflammation or macular edema. 12. Are currently being treated with immunomodulating agents in the study eye(s). 13. Are currently being treated with immunosuppressants an/or oral steroids. 14. Are Pregnant or breast-feeding or wish to become pregnant during the length of study participation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Complete Absence of Ocular Pain at Day 8 | at Day 8 | Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8. |
| Participants With Zero Cells on Day 14 | at Day 14 | Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ease of Insertion | Day 0 | Rated as Easy, Moderate, Difficult |
| Attempts to Achieve Successful Insertion | Day 0 | Number of attempts to insert the dexamethasone insert in the upper or lower punctum. |
Countries
United States
Participant flow
Recruitment details
Single medical clinic open enrollment from June-October 2022.
Participants by arm
| Arm | Count |
|---|---|
| Lower Punctum Insertion (Group 1) DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use
Group 1 (up to 40 eyes) will receive the insert in the lower punctum on the day of surgery in the OR.
Dextenza 0.4Mg Ophthalmic Insert: (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. | 39 |
| Upper Punctum Insertion (Group 2) DEXTENZA (dexamethasone ophthalmic insert, 0.4mg) for intracanalicular use
Group 2 (up to 40 eyes) will receive the insert in the upper punctum on the of surgery in the OR.
Dextenza 0.4Mg Ophthalmic Insert: (dexamethasone ophthalmic insert)-for the treatment of ocular inflammation and pain following following ophthalmic surgery, and ocular itching associated with allergic conjunctivitis. | 40 |
| Total | 79 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Lower Punctum Insertion (Group 1) | Upper Punctum Insertion (Group 2) | Total |
|---|---|---|---|
| Age, Continuous | 68.5 years STANDARD_DEVIATION 8.1 | 68.3 years STANDARD_DEVIATION 9.1 | 68.4 years STANDARD_DEVIATION 0.5 |
| Cataract Type Cortical | 12 Participants | 14 Participants | 26 Participants |
| Cataract Type Nuclear | 27 Participants | 26 Participants | 53 Participants |
| Race/Ethnicity, Customized Race African American | 35 Participants | 34 Participants | 69 Participants |
| Race/Ethnicity, Customized Race White | 4 Participants | 6 Participants | 10 Participants |
| Sex: Female, Male Female | 23 Participants | 26 Participants | 49 Participants |
| Sex: Female, Male Male | 16 Participants | 14 Participants | 30 Participants |
| Surgical Procedure Cataract-MIGS | 4 Participants | 5 Participants | 9 Participants |
| Surgical Procedure Cataract Surgery Only | 35 Participants | 35 Participants | 70 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 40 |
| other Total, other adverse events | 4 / 39 | 4 / 40 |
| serious Total, serious adverse events | 0 / 39 | 0 / 40 |
Outcome results
Primary
Participants With Complete Absence of Ocular Pain at Day 8
Participant reported ocular pain on a scale of (0-10) with zero (0) equaling no pain and ten(10) equaling maximal pain on day 8.
Time frame: at Day 8
Population: Participants with complete absence of ocular pain at day 8
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lower Punctum Insertion (Group 1) | Participants With Complete Absence of Ocular Pain at Day 8 | Post Op Pain Reported | 0 Participants |
| Lower Punctum Insertion (Group 1) | Participants With Complete Absence of Ocular Pain at Day 8 | No Post Op Pain Reported | 39 Participants |
| Lower Punctum Insertion (Group 2) | Participants With Complete Absence of Ocular Pain at Day 8 | No Post Op Pain Reported | 39 Participants |
| Lower Punctum Insertion (Group 2) | Participants With Complete Absence of Ocular Pain at Day 8 | Post Op Pain Reported | 1 Participants |
Primary
Participants With Zero Cells on Day 14
Proportion of of participants with complete absence of anterior chamber cell at Day 14 as measured by Summed Ocular Inflammation Score (0-4).
Time frame: at Day 14
Population: Lower and Upper Punctum Insertion
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lower Punctum Insertion (Group 1) | Participants With Zero Cells on Day 14 | Patients with Zero Cell | 38 Participants |
| Lower Punctum Insertion (Group 1) | Participants With Zero Cells on Day 14 | Patients with Cell | 1 Participants |
| Lower Punctum Insertion (Group 2) | Participants With Zero Cells on Day 14 | Patients with Zero Cell | 37 Participants |
| Lower Punctum Insertion (Group 2) | Participants With Zero Cells on Day 14 | Patients with Cell | 3 Participants |
Secondary
Attempts to Achieve Successful Insertion
Number of attempts to insert the dexamethasone insert in the upper or lower punctum.
Time frame: Day 0
Population: Attempts at Upper and Lower insertion
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lower Punctum Insertion (Group 1) | Attempts to Achieve Successful Insertion | One Attempt | 38 Participants |
| Lower Punctum Insertion (Group 1) | Attempts to Achieve Successful Insertion | Two Attempts | 1 Participants |
| Lower Punctum Insertion (Group 2) | Attempts to Achieve Successful Insertion | One Attempt | 35 Participants |
| Lower Punctum Insertion (Group 2) | Attempts to Achieve Successful Insertion | Two Attempts | 5 Participants |
Secondary
Ease of Insertion
Rated as Easy, Moderate, Difficult
Time frame: Day 0
Population: Easy, Moderate, Difficult.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Lower Punctum Insertion (Group 1) | Ease of Insertion | Easy | 36 Participants |
| Lower Punctum Insertion (Group 1) | Ease of Insertion | Moderate | 2 Participants |
| Lower Punctum Insertion (Group 1) | Ease of Insertion | Difficult | 1 Participants |
| Lower Punctum Insertion (Group 2) | Ease of Insertion | Easy | 36 Participants |
| Lower Punctum Insertion (Group 2) | Ease of Insertion | Moderate | 4 Participants |
| Lower Punctum Insertion (Group 2) | Ease of Insertion | Difficult | 0 Participants |