Dry Eye Disease
Conditions
Keywords
Dry Eyes, Eye Drops
Brief summary
The purpose of this study is to evaluate tear production following acute administration of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) in subjects with dry eye disease (DED).
Detailed description
Qualified subjects will attend a single visit. This is a Phase 3b, 2-stage study. In Stage 1, approximately 40 subjects will be enrolled, after which the study will be paused and an interim analysis will be conducted. Results from the Stage 1 analysis will help inform the design of Stage 2. An additional 40 subjects are planned for Stage 2. For both stages, the primary endpoint and analysis will remain the same. Stage 2 will be tested independently with no pooling of data between stages.
Interventions
Investigational ophthalmic solution administered via topical instillation
Sponsors
Alcon Research
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Within the last 12 months, have a previous history of dry eye disease, either clinician diagnosed or patient reported. * Within the last 6 months, have used, or desired to use artificial tears for dry eye symptoms. * Corrected visual acuity score of 20/200 or better in both eyes. * Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history. * Other protocol specified inclusion criteria may apply. Key
Exclusion criteria
* Current evidence of any clinically significant ophthalmic disease other than dry eye (for example, glaucoma or macular degeneration). * History of ocular surgery within 1 year of the Study Visit. * Use of contact lenses in either eye within 7 days of the Study Visit. * Use of lid hygiene (all forms of lid care) or heat masks within 7 days of the Study Visit. * Use of any topical ocular anti-inflammatory medications, any topical ocular corticosteroid, or any non-steroidal-anti-inflammatory agents within 30 days of the Study Visit. * Used artificial tears within 2 hours of the Study Visit. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 1 | Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation | TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis. |
| Mean Change From Baseline in Tear Meniscus Height (TMH) at Minute 3 - Stage 2 | Day 1, Minute 0 pre-instillation (Baseline); Day 1, Minute 3 post-instillation | TMH (the distance between the line of reflection along the top of the tear prism to the edge of the central lower eyelid) was measured pre-instillation and post-instillation in micrometers using optical coherence tomography (OCT), a non-invasive imaging test that uses light waves to take cross-section pictures of the eye. A normal TMH range falls between 200 and 400 micrometers. Measurements below this range may indicate dry eye disease. A positive change value indicates an improvement. One eye (study eye, defined as the left eye) contributed data to the analysis. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Lead, Pharma
Alcon Research, LLC
Participant flow
Recruitment details
Participants were recruited from 1 investigative site located in the United States.
Pre-assignment details
This reporting group includes all subjects treated with 0.003% AR-15512 (81).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 62.5 years STANDARD_DEVIATION 14.8 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 0 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 11 Participants |
| Race/Ethnicity, Customized Multi-Racial | 0 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 30 Participants |
| Race/Ethnicity, Customized Other | 0 Participants |
| Race/Ethnicity, Customized White | 28 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 81 | 0 / 40 | 0 / 41 |
| other Total, other adverse events | 0 / 81 | 19 / 40 | 16 / 41 |
| serious Total, serious adverse events | 0 / 81 | 0 / 40 | 0 / 41 |
Outcome results
None listed