Refractive Surgery
Conditions
Brief summary
To determine patient preference and treatment outcomes with an intracanalicular dexamethasone (0.4mg) insert compared to standard steroid drop regimen in the contralateral eye following bilateral PRK surgery.
Detailed description
Prospective Open-label Interventional Study Randomized, self-controlled design in which one eye (Group A) receives Dextenza and the second eye (Group B) receives prednisolone acetate 1% QID 1 week, BID 1 week following bilateral PRK surgery. All eyes will receive topical moxifloxacin QID for one week. Moxifloxacin in used post-op regardless of the research. Post-operative evaluations to be performed on Day 3 and Day 4, Month 1, and Month 3. Phone call survey to be performed on Week 2.
Interventions
The insert, containing 0.4 mg of active pharmaceutical product, is placed within the canaliculus to provide a sustained and tapered delivery of drug to the ocular surface over 30 days after a one-time insertion. The attributes of the insert reduce the risks for improper corticosteroid tapering and unwanted peaks and troughs in drug concentration.
Standard of care topical drop treatment
Sponsors
Ocular Therapeutix, Inc.
Vance Thompson Vision
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Any adult patient who is planned to undergo bilateral PRK surgery. * Willing and able to comply with clinic visits and study related procedures * Willing and able to sign the informed consent form
Exclusion criteria
* Patients under the age of 18. * Patients who are pregnant (must be ruled out in women of child-bearing age with pregnancy test). * Active infectious ocular or systemic disease. * Patients with active infectious ocular or extraocular disease. * Patients actively treated with local or systemic immunosuppression including systemic corticosteroids. * Patients with known hypersensitivity to Dexamethasone. * Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator. * Patients with a history of ocular inflammation or macular edema. * Patients with allergy or inability to receive intracameral antibiotic. * Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day * Patients with a corticosteroid implant (i.e. Ozurdex). * Patient with corneal pathology which pre-disposes them to unsatisfactory outcomes. * Patients who do not have 20/20 snellen visual acuity potential pre-operatively. * MRSE greater than 6 diopters. * Greater than 2 diopters anisometropia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Preference | Through Month 1 (Day 28 +/- 3 days) | Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Eyes Fully Epithelialized at Day 4 Postoperative | Postoperative Day 4 | The percentage of eyes with fully healed epithelium at day 4 post-operative |
| Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid) | Day 3 | Pain score as measured by the Numerical Rating Scale (NRS) at day 3 post-operative. The rating scale is from 0-10 with 0 being no pain and 10 being severe pain. |
| Percentage of Eyes Epithelialized at Day 3 | Post-Operative Day 3 | The percentage of eyes with fully healed epithelium at post-op day 3 |
| Uncorrected Distance Visual Acuity | Month 1 and Month 3. | measured using the ETDRS acuity chart at 4 meters recorded in logMAR. |
| Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative | Month 1 and Month 3 | Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation |
| SPEED Questionnaire Results at Baseline and Postoperative Day 28 | Pre-op Visit and Month 1 (Day 28) | Patient evaluation of eye dryness measured by a modified SPEED questionnaire with a results recorded 0-28 with 28 being the most severe. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Participants 40 Eyes of 20 Patients. | 20 |
| All Participants 40 Eyes of 20 Patients. | 40 |
| Total | 60 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Age, Continuous | 32 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Region of Enrollment United States | 20 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 |
| other Total, other adverse events | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Patient Preference
Primary outcome of patient reference of dexamethasone insert versus topical steroid as measured by adapted Comparison of Ophthalmic Medications for Tolerability (COMToL) questionnaire.
Time frame: Through Month 1 (Day 28 +/- 3 days)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Participants | Patient Preference | Dexamethasone insert preference | 14 Participants |
| All Participants | Patient Preference | Topical steroid preference | 4 Participants |
| All Participants | Patient Preference | No preference | 2 Participants |
Secondary
Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid)
Pain score as measured by the Numerical Rating Scale (NRS) at day 3 post-operative. The rating scale is from 0-10 with 0 being no pain and 10 being severe pain.
Time frame: Day 3
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid) | 0.9 score on a scale | Standard Deviation 0.995 |
| Topical Steroid | Mean Pain Score Per Eye (Group A: Dextenza vs. Group B: Topical Steroid) | 0.850 score on a scale | Standard Deviation 0.853 |
Secondary
Percentage of Eyes Epithelialized at Day 3
The percentage of eyes with fully healed epithelium at post-op day 3
Time frame: Post-Operative Day 3
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| All Participants | Percentage of Eyes Epithelialized at Day 3 | Percent epithelialized at Day 3 | 20 eyes |
| All Participants | Percentage of Eyes Epithelialized at Day 3 | Percent not 100% epithelialized at Day 3 | 0 eyes |
| Topical Steroid | Percentage of Eyes Epithelialized at Day 3 | Percent epithelialized at Day 3 | 20 eyes |
| Topical Steroid | Percentage of Eyes Epithelialized at Day 3 | Percent not 100% epithelialized at Day 3 | 0 eyes |
Secondary
Percentage of Eyes Fully Epithelialized at Day 4 Postoperative
The percentage of eyes with fully healed epithelium at day 4 post-operative
Time frame: Postoperative Day 4
| Arm | Measure | Category | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| All Participants | Percentage of Eyes Fully Epithelialized at Day 4 Postoperative | Percentage of eyes fully epithelialized at day 4 | 19 eyes |
| All Participants | Percentage of Eyes Fully Epithelialized at Day 4 Postoperative | Percentage of eyes not fully epithelialized at day 4 | 1 eyes |
| Topical Steroid | Percentage of Eyes Fully Epithelialized at Day 4 Postoperative | Percentage of eyes fully epithelialized at day 4 | 20 eyes |
| Topical Steroid | Percentage of Eyes Fully Epithelialized at Day 4 Postoperative | Percentage of eyes not fully epithelialized at day 4 | 0 eyes |
Secondary
Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative
Best-corrected distance visual acuity measured using ETDRS acuity chart at 4 meters, recorded in logMAR notation
Time frame: Month 1 and Month 3
Population: 40 eyes of 20 participants analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative | Month 1 | -0.051 logMAR | Standard Deviation 0.066 |
| All Participants | Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative | Month 3 | -0.146 logMAR | Standard Deviation 0.043 |
| Topical Steroid | Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative | Month 1 | -0.093 logMAR | Standard Deviation 0.05 |
| Topical Steroid | Spectacle Corrected Distance Visual Acuity at Months 1 and 3 Post-operative | Month 3 | -0.167 logMAR | Standard Deviation 0.044 |
Secondary
SPEED Questionnaire Results at Baseline and Postoperative Day 28
Patient evaluation of eye dryness measured by a modified SPEED questionnaire with a results recorded 0-28 with 28 being the most severe.
Time frame: Pre-op Visit and Month 1 (Day 28)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | SPEED Questionnaire Results at Baseline and Postoperative Day 28 | Baseline | 3.75 score on a scale | Standard Deviation 4.05 |
| All Participants | SPEED Questionnaire Results at Baseline and Postoperative Day 28 | Day 28 | 4.00 score on a scale | Standard Deviation 4.07 |
| Topical Steroid | SPEED Questionnaire Results at Baseline and Postoperative Day 28 | Baseline | 3.70 score on a scale | Standard Deviation 4.11 |
| Topical Steroid | SPEED Questionnaire Results at Baseline and Postoperative Day 28 | Day 28 | 4.22 score on a scale | Standard Deviation 4.98 |
Secondary
Uncorrected Distance Visual Acuity
measured using the ETDRS acuity chart at 4 meters recorded in logMAR.
Time frame: Month 1 and Month 3.
Population: A total of 40 eyes of 20 participants was analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| All Participants | Uncorrected Distance Visual Acuity | Uncorrected distance visual acuity at month 1 | 0.0005 logMAR | Standard Deviation 0.121 |
| All Participants | Uncorrected Distance Visual Acuity | Uncorrected distance visual acuity at month 3 | -1.117 logMAR | Standard Deviation 0.068 |
| Topical Steroid | Uncorrected Distance Visual Acuity | Uncorrected distance visual acuity at month 1 | -0.073 logMAR | Standard Deviation 0.067 |
| Topical Steroid | Uncorrected Distance Visual Acuity | Uncorrected distance visual acuity at month 3 | -0.153 logMAR | Standard Deviation 0.057 |