Allergic Conjunctivitis
Conditions
Brief summary
The purpose of this study is to compare the effects of two marked ocular anti-allergy medications in cat sensitive subjects with allergic conjunctivitis.
Interventions
DRUGElestat
Elestat BID for 2 days
DRUGPataday
Pataday QD for 2 days
Sponsors
Merck Sharp & Dohme LLC
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
* Documented history of ocular allergy to cats. * Positive skin prick allergen reaction to cat dander.
Exclusion criteria
* Use of any topical or systemic corticosteroids, immunosuppressive agents, antihistamines, decongestants, NSAIDs, or asprin during the two weeks prior to enrollment into the study. * History of severe asthma, reactive airway disease or bronchial obstruction. * Ocular surgery or trauma in the last year.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Ocular Itch Score From Baseline | 0 hours, 12 hours | Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Comfort Score at 12 Hours | 12 hours | Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Elestat 1 drop each eye for 2 days | 40 |
| Pataday 1 drop each eye for 1 day | 39 |
| Total | 79 |
Baseline characteristics
| Characteristic | Elestat | Pataday | Total |
|---|---|---|---|
| Age, Continuous | 41.3 years STANDARD_DEVIATION 12.18 | 40.1 years STANDARD_DEVIATION 13.41 | 40.7 years STANDARD_DEVIATION 12.73 |
| Sex: Female, Male Female | 20 Participants | 27 Participants | 47 Participants |
| Sex: Female, Male Male | 20 Participants | 12 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Change in Ocular Itch Score From Baseline
Ocular itch was measured on a 0 (none) to 4 (severe itch with continual desire to rub eyes) scale. Negative values for change from baseline represent favorable outcomes.
Time frame: 0 hours, 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elestat | Change in Ocular Itch Score From Baseline | -1.5 units on a scale | Standard Deviation 1.36 |
| Pataday | Change in Ocular Itch Score From Baseline | -1.5 units on a scale | Standard Deviation 1.07 |
Comparison: ITT (Intent to Treat)p-value: 0.532ANCOVA
Secondary
Ocular Comfort Score at 12 Hours
Ocular comfort was measured on a 0 (more uncomfortable) to 10 (more comfortable) scale.
Time frame: 12 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Elestat | Ocular Comfort Score at 12 Hours | 8.6 units on a scale | Standard Deviation 1.62 |
| Pataday | Ocular Comfort Score at 12 Hours | 8.5 units on a scale | Standard Deviation 1.94 |
Comparison: ITT (Intent to Treat)p-value: 0.927Student's t-test