Eyes Dry Chronic
Conditions
Keywords
Ocular discomfort
Brief summary
The purpose of this study was to evaluate the efficacy of ESBA105 over vehicle in reducing the ocular symptoms of dry eye disease, as measured by a mean global Visual Analog Scale (VAS) discomfort score.
Detailed description
Following Run-In, patients qualifying for treatment were randomized 2:1 to receive ESBA105 (experimental group) or Vehicle (control group) for 4 weeks. Patients not qualifying for treatment (based on global VAS discomfort score), were discontinued from the study.
Interventions
BIOLOGICALESBA105 ophthalmic solution
OTHERESBA105 vehicle
Inactive ingredients used as Run-In and placebo comparator
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
* Ongoing physician diagnosis of dry eye for at least 6 months. * Use of artificial tears, gels, lubricants, or re-wetting drops on a regular basis. * Experience persistent ocular discomfort. * Other protocol-defined inclusion criteria may apply.
Exclusion criteria
* Contact lens wearers. * Severe Sjogren's Syndrome. * History of corneal surgery including refractive surgeries. * Intraocular surgery within 6 months of Visit 1. * Intraocular or periocular injection within 6 months of Visit 1. * Lid function abnormalities. * Use of steroids, tetracycline, doxycycline, etc., within 30 days of Visit 1. * Any acute infectious or non-infectious ocular condition of the anterior or posterior segments in either eye within 30 days of Visit 1. * Diseases/conditions of ocular surface associated with clinically significant scarring/destruction of conjunctiva/cornea. * Other protocol-defined
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28 | Up to 28 days | An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100). |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited from 16 investigative sites located within the United States. Participant flow data is presented for all subjects exposed to product.
Pre-assignment details
Of the 334 enrolled, 210 subjects did not qualify for Run-In and were exited from the study without exposure to product. Of the 124 entering Run-In, 39 did not qualify for treatment. The 85 subjects qualifying for treatment were randomized 2:1 to receive either ESBA105 or Vehicle.
Participants by arm
| Arm | Count |
|---|---|
| Run-In Only ESBA105 vehicle | 39 |
| ESBA105 ESBA 105 vehicle (Run-In), ESBA105 ophthalmic solution (treatment) | 56 |
| Vehicle ESBA105 vehicle (Run-In), ESBA105 vehicle (treatment) | 29 |
| Total | 124 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 | 0 |
| Overall Study | Patient Decision Unrelated to Advs Event | 1 | 1 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 1 |
Baseline characteristics
| Characteristic | Run-In Only | ESBA105 | Vehicle | Total |
|---|---|---|---|---|
| Age, Customized <65 | 24 participants | 32 participants | 21 participants | 77 participants |
| Age, Customized ≥65 | 15 participants | 24 participants | 8 participants | 47 participants |
| Region of Enrollment United States | 39 participants | 56 participants | 29 participants | 124 participants |
| Sex: Female, Male Female | 35 Participants | 45 Participants | 26 Participants | 106 Participants |
| Sex: Female, Male Male | 4 Participants | 11 Participants | 3 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 124 | 0 / 56 | 0 / 29 |
| serious Total, serious adverse events | 0 / 124 | 0 / 56 | 0 / 29 |
Outcome results
Primary
Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28
An electronic Visual Analog Scale (eVAS) was used by the subject to assess ocular discomfort, both frequency and severity, at Day 0 (pre-treatment) and daily thereafter for 28 days. Assessments were entered into a LogPad® (handheld electronic device). The VAS frequency score ranged from 0 (rarely) to 100 (all the time), and the VAS severity score ranged from 0 (very mildly uncomfortable) to 100 (very severely uncomfortable). The Global Ocular Discomfort Score is a composite of the frequency and severity VAS scores (0-100).
Time frame: Up to 28 days
Population: All subjects randomized to treatment and receiving at least 1 administration of study medication (intent-to-treat). Mixed model repeated measure (MMRM) approach was used to handle missing data during randomized treatment period.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| ESBA105 | Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28 | 63.8773 Units on a scale x days | Standard Error 2.4832 |
| Vehicle | Visual Analog Scale (VAS) Global Ocular Discomfort Score, Area Under the Curve, Day 0 to Day 28 | 70.2194 Units on a scale x days | Standard Error 2.39802 |