Dry Eye
Conditions
Keywords
dexamethasone ophthalmic insert
Brief summary
To assess the efficacy and safety of OTX-DED for the short-term treatment of signs and symptoms of dry eye disease.
Detailed description
Randomized, double-masked, vehicle-controlled, phase 2 study evaluating the efficacy and safety of OTX-DED (dexamethasone intracanalicular ophthalmic insert) for the short-term treatment of signs and symptoms of Dry Eye Disease (DED). The subjects will be followed for approximately 2-3 months from screening to the last visit.
Interventions
DRUGOTX-DED
0.2mg dexamethasone ophthalmic insert
Sponsors
Ocular Therapeutix, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
Parallel: Participants are assigned to one of two or more groups in parallel for the duration of the study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Dry Eye Disease diagnosis * VAS eye dryness severity score ≥ 40.
Exclusion criteria
* Are unwilling to discontinue use of contact lenses * Are unwilling to withhold use of artificial tears.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). | Change from baseline (Day 1) at Visit 4 (Day 15) | The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia \[evaluated by the central reading center (CRC)\] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert Subjects in this arm received 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert | 55 |
| OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert Subjects in this arm received 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert | 56 |
| Hydrogel Vehicle (HV) Intracanalicular Insert Subjects in this arm received Hydrogel Vehicle (HV) Intracanalicular Insert | 55 |
| Total | 166 |
Baseline characteristics
| Characteristic | OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert | OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert | Hydrogel Vehicle (HV) Intracanalicular Insert | Total |
|---|---|---|---|---|
| Age, Continuous | 63.7 years STANDARD_DEVIATION 11 | 65.4 years STANDARD_DEVIATION 11.4 | 63.8 years STANDARD_DEVIATION 12.3 | 64.3 years STANDARD_DEVIATION 11.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 4 Participants | 6 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 11 Participants | 14 Participants | 8 Participants | 33 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 | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 39 Participants | 38 Participants | 41 Participants | 118 Participants |
| Sex: Female, Male Female | 41 Participants | 39 Participants | 41 Participants | 121 Participants |
| Sex: Female, Male Male | 14 Participants | 17 Participants | 14 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 56 | 0 / 55 |
| other Total, other adverse events | 5 / 55 | 10 / 56 | 6 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 56 | 2 / 55 |
Outcome results
Primary
Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center).
The primary efficacy endpoint is photographic assessment of bulbar conjunctival hyperemia \[evaluated by the central reading center (CRC)\] in the study eye, change in score from baseline (CFB) at Visit 4 (Day 15). Scoring is from 0 (None) to 4 (Severe) on the CCLRU Grading Scale for Bulbar Conjunctival Hyperemia.
Time frame: Change from baseline (Day 1) at Visit 4 (Day 15)
Population: mITT population: CFB in Photographic Assessment of Bulbar Conjunctival Hyperemia in the Worst Zone (highest grading score at baseline among nasal, temporal, and frontal zones) of Study Eye at Day 15
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| OTX-DED 0.2mg Dexamethasone Intracanalicular Ophthalmic Insert | Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). | -0.51 score on a scale |
| OTX-DED 0.3mg Dexamethasone Intracanalicular Ophthalmic Insert | Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). | -0.43 score on a scale |
| Hydrogel Vehicle (HV) Intracanalicular Insert | Photographic Assessment of Bulbar Conjunctival Hyperemia Change in Score From Baseline (CFB) at 15 Days (Evaluated Via Central Reading Center). | -0.21 score on a scale |