Dry Eye Disease
Conditions
Keywords
Dry Eyes, Eye Drops
Brief summary
The purpose of this study is to evaluate the effect of AR-15512 ophthalmic solution 0.003% (0.003% AR-15512) on ocular surface characteristics of subjects with dry eye disease (DED).
Detailed description
Qualified subjects will enter a 14-day run-in period, followed by a 13-week randomized treatment period, for a total individual duration of participation of approximately 15 weeks. During the run-in period, subjects will administer Artificial Tears (REFRESH® Classic) as one drop in each eye twice daily. This is a Phase 3b study.
Interventions
Investigational ophthalmic solution administered via topical instillation
OTHERArtificial Tears
Commercially available, preservative-free lubricant eye drops administered via topical instillation
Sponsors
Alcon Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Have a previous history of DED, clinician diagnosed or patient reported, within the previous 6 months prior to the Screening visit. * Have used artificial tears for DED symptoms within 2 months prior to the Screening visit. * Corrected visual acuity equal to or better than logarithm Minimum angle of reflection (logMar) +0.7 (Snellen equivalent equal to or better than 20/100), as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at both the Screening and Baseline visits. * 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
* History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, interfere with the interpretation of the study results or subject safety. * Current evidence of other significant ophthalmic disease requiring topical medication (e.g., glaucoma, ocular hypertension), or other ophthalmic disease which the investigator believes may interfere with study findings or interpretation. * History of ocular surgery within 1 year prior to the Screening visit; history of corneal transplant in one or both eyes. * Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study. * Regular use, as assessed by the investigator, of lid hygiene or heat masks within 14 days prior to the Screening visit or any planned use during the study. * Use of lid heating therapy or Meibomian gland probing/therapeutic expression within 1 year prior to the Screening visit or anticipated during the study. * Other protocol-specified
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Least Squares Mean Percentage Change From Baseline in Goblet Cell Density at Day 90 for 0.003% AR-15512 | Day 1 pre-instillation (Baseline), Day 90 post instillation | Goblet cells are specialized epithelial cells that secrete mucins onto the ocular surface to help hydrate and lubricate the eye surface. Samples of conjunctiva were collected on filter papers based on a technique called impression cytology. The filter papers were then processed in a lab to measure the number of goblet cells (cells/mm2). The percent change in goblet cell density at Day 90 compared to Day 1 (Baseline) was calculated. A positive change value indicates an improvement. Only one eye (study eye) contributed data to the analysis. This outcome measure was pre-specified for 0.003% AR-15512 arm only. |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trial Lead, Pharma
Alcon Research, LLC
Participant flow
Recruitment details
Participants were recruited from 4 investigative sites located in the United States.
Pre-assignment details
This reporting group includes all randomized/treated subjects (80).
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 63.5 years STANDARD_DEVIATION 11.75 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants |
| Race/Ethnicity, Customized Asian | 0 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants |
| Race/Ethnicity, Customized Multi-Racial | 1 Participants |
| Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Race/Ethnicity, Customized Unknown | 0 Participants |
| Race/Ethnicity, Customized White | 71 Participants |
| Region of Enrollment United States | 41 participants |
| Sex: Female, Male Female | 59 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 39 | 0 / 41 |
| other Total, other adverse events | 2 / 80 | 24 / 39 | 4 / 41 |
| serious Total, serious adverse events | 0 / 80 | 0 / 39 | 1 / 41 |
Outcome results
None listed