Dry Eye Disease
Conditions
Keywords
Dry Eyes
Brief summary
The purpose of this study is to evaluate the percentage of ocular adverse events reported in subjects with dry eye disease (DED) between the intervention arm (0.003% AR-15512) and control arm (REFRESH® Classic).
Detailed description
Subjects will be randomized to one of four sequences of 0.003% AR-15512 ophthalmic solution instillation variations which will be administered after administration of control (REFRESH® Classic). This is a 1-visit study (Screening, Enrollment, Assessments).
Interventions
Investigational ophthalmic solution administered topically in 4 different instillation variations: 512-RT (0.003% AR-15512 instilled at room temperature, eyes to remain open post-drop instillation); 512-COLD (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator, eyes to remain open post-drop instillation); 512-RT-EC (0.003% AR-15512 instilled at room temperature followed by subjects immediately closing their eyes); and 512-COLD-EC (0.003% AR-15512 stored in refrigerator and instilled immediately after removal from refrigerator followed by subjects immediately closing their eyes).
DRUGArtificial tears
Commercially available, preservative-free lubricant eye drops administered topically
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Corrected Visual Acuity (Snellen) 20/200 or better in both eyes; * Good general and ocular health, as determined by the Investigator using medical history, ophthalmic examination and history; * Capable of giving signed informed consent. * Other protocol-defined inclusion criteria may apply. Key
Exclusion criteria
* Current evidence of other clinically significant ophthalmic disease other than dry eye; * History of ocular surgery within 1 year of the Study Visit; * Use of any topical ocular anti-inflammatory medications (for example, Restasis®, Cequa™, Vevye™, Xiidra®), other prescription ophthalmic product for dry eyes, topical ocular corticosteroid, or non-steroidal-anti-inflammatory agents within 30 days of the Study Visit; * Positive pregnancy test or currently breastfeeding. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Ocular Treatment-Emergent Adverse Events Attributed to Study Intervention | Up to Day 1 post drop instillation | Treatment-emergent adverse events (TEAEs) were defined as any event that occurred or worsened on or after the day that study intervention was initiated. No hypothesis testing was prespecified for this endpoint. |
Countries
United States
Contacts
STUDY_DIRECTORSr. Clinical Trial Lead, Pharma
Alcon Research, LLC
Participant flow
Recruitment details
Participants were recruited from 6 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all randomized subjects (55).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 66.2 years STANDARD_DEVIATION 11.82 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 7 Participants |
| Race/Ethnicity, Customized Multi-Racial | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants |
| Race/Ethnicity, Customized White | 10 Participants |
| Region of Enrollment United States | 55 participants |
| Sex: Female, Male Female | 46 Participants |
| Sex: Female, Male Male | 2 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 / 55 | 0 / 55 |
| other Total, other adverse events | 0 / 55 | 0 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 | 0 / 55 |
Outcome results
None listed