Dry Eye Syndrome
Conditions
Keywords
Dry Eye Syndrome, ABBV-444
Brief summary
Dry Eye Disease (DED) is a condition where the tear film of the eye becomes unstable and along with ocular surface inflammation and damage leads to inadequate tear production and eye lubrication. This study will evaluate symptom relief and tolerability of ABBV-444 eye drops in adult participants. ABBV-444 is being developed for the treatment of Dry Eye Disease (DED). This is a 30-day, open-label study to evaluate adult participant symptoms and tolerability of ABBV-444. Around 40 participants will be enrolled in 1 site in the United States. Participants will receive 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, checking for side effects and completing questionnaires.
Interventions
DRUGABBV-444
Lubricant Eye drops
Sponsors
AbbVie
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
* Had used artificial tears for dry eyes within the past year * OSDI score of ≥ 18 and ≤ 65 (based upon a 0 to 100 scale) at Screening and Baseline Visits Three consecutive tear breakup time (TBUT) tests ≤ 10 seconds in at least 1 eye at Day -7 (screening) * Grade 1 to 4 (modified National Eye Institute \[NEI\] Grid, score range = 0 to 5) staining in at least 1 area of the cornea (5 areas examined) or conjunctiva (6 areas examined) that was related to dry eye in at least 1 eye at both at Screening and Baseline Visits
Exclusion criteria
* Have uncontrolled severe systemic disease that, in the assessment of the investigator, would put safety of the participant at risk through participation, or which would prevent or confound protocol-specified assessments (e.g., hypertension and diabetes, Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, immunodeficiency disease, etc.) * Known allergy or sensitivity to the study products or their components * Schirmer Test (with anesthesia) ≤ 2 mm in either eye at Screening Visit * Participant anticipated contact lens wear during the study, or the participant had worn contact lenses in the last 3 months prior to Screening Visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline to Day 30 in Ocular Surface Disease Index (OSDI) Score | Baseline to Day 30 | The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | Day 30 | The PEDE Survey is a 13-item questionnaire that evaluates the short- and long-term subjective experience in comfort and vision as well as tolerability, using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). On Day 30, participants were asked to retrospectively recall their experiences after 5 minutes, 30 minutes, 24 hours, and 5 days of when they administered the eye drops |
| Change From Baseline in Symptom Scores (Visual Analog Scale) Within 5 Minutes Post Administration of ABBV-444 | Baseline (T0) to 5 minutes (T5) | The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the present moment using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). Surveys were completed 5 minutes following the first administration of study eye drops. A negative number change from baseline represents an improvement. |
Countries
United States
Participant flow
Recruitment details
A total of 40 participants were enrolled and included in the intent-to-treat (ITT) population. The per-protocol (PP) population included 34 participants after excluding 4 participants who were deemed protocol deviations and 2 participants who discontinued the study. The per-protocol population was used for all efficacy measures.
Pre-assignment details
Four participants were deemed protocol deviations following data entry and analysis because their baseline OSDI scores were outside the 18 to 65 inclusion range. The 4 participants were not included in the per protocol population.
Participants by arm
| Arm | Count |
|---|---|
| ABBV-444 Participants administered 1-2 drops of ABBV-444 in each eye as needed, but minimally twice a day for 30 days. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 2 |
Baseline characteristics
| Characteristic | ABBV-444 |
|---|---|
| Age, Continuous | 37.7 years STANDARD_DEVIATION 15.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 38 Participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Change From Baseline to Day 30 in Ocular Surface Disease Index (OSDI) Score
The OSDI is a 12-question survey for participants to document their dry eye disease symptoms. The OSDI consists of a 5-point scale ranging from 0 (none of the time) to 4 (all of the time), with higher scores representing greater disability. The scores from the 12 questions are totaled and converted to an overall score ranging from 0 (no disability) to 100 (complete disability). A negative number change from baseline represents an improvement.
Time frame: Baseline to Day 30
Population: The analysis is based on the full analysis set (FAS), consisting of all participants who were eligible based on the inclusion and exclusion criteria and completed 30 days of treatment for this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABBV-444 | Change From Baseline to Day 30 in Ocular Surface Disease Index (OSDI) Score | -6.8 score on a scale | Standard Deviation 15 |
Secondary
Change From Baseline in Symptom Scores (Visual Analog Scale) Within 5 Minutes Post Administration of ABBV-444
The Current Symptom Survey is a 5-item questionnaire where the participants rate their ocular symptoms at the present moment using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). Surveys were completed 5 minutes following the first administration of study eye drops. A negative number change from baseline represents an improvement.
Time frame: Baseline (T0) to 5 minutes (T5)
Population: The analysis is based on the full analysis set (FAS), consisting of all participants who were eligible based on the inclusion and exclusion criteria and completed 30 days of treatment for this study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ABBV-444 | Change From Baseline in Symptom Scores (Visual Analog Scale) Within 5 Minutes Post Administration of ABBV-444 | -10.1 score on a scale | Standard Deviation 10.6 |
Secondary
Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale)
The PEDE Survey is a 13-item questionnaire that evaluates the short- and long-term subjective experience in comfort and vision as well as tolerability, using a scale ranging from 0 (strongly disagree) to 100 (strongly agree). On Day 30, participants were asked to retrospectively recall their experiences after 5 minutes, 30 minutes, 24 hours, and 5 days of when they administered the eye drops
Time frame: Day 30
Population: The analysis is based on the full analysis set (FAS), consisting of all participants who were eligible based on the inclusion and exclusion criteria and completed 30 days of treatment for this study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | The study eye drops provided comfort to my eye dryness day and night (24 hours) | 84.5 score on a scale | Standard Deviation 21.5 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | The study eye drops do not cause stinging or burning in my eyes (5 minutes) | 76.4 score on a scale | Standard Deviation 36.7 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | Study eye drops provided immediate relief of my eye dryness when putting in my eyes (5 minutes) | 77.1 score on a scale | Standard Deviation 27.9 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | Study eye drops immediately soothed my eye dryness when putting in my eyes (5 minutes) | 81.3 score on a scale | Standard Deviation 25.3 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | Did not experience much blurry/fluctuating vision after putting study eye drops in my eyes (5 mins) | 77.5 score on a scale | Standard Deviation 30.4 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | Study eye drops provided immediate comfort to my eye dryness when putting in my eyes (5 minutes) | 84.1 score on a scale | Standard Deviation 21.1 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | The study eye drops are very soothing for my eye dryness (30 minutes) | 82.0 score on a scale | Standard Deviation 25.6 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | The study eye drops did not feel sticky (30 minutes) | 78.6 score on a scale | Standard Deviation 30.8 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | The study eye drops continued to provide relief of my eye discomfort (30 minutes) | 84.6 score on a scale | Standard Deviation 20.7 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | The study eye drops continued to provide comfort to my eye dryness (30 minutes) | 85.7 score on a scale | Standard Deviation 21 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | The study eye drops provided relief of my eye dryness day and night (24 hours) | 84.4 score on a scale | Standard Deviation 20 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | The study eye drops provided lasting relief of my eye dryness (5 days) | 83.8 score on a scale | Standard Deviation 23.2 |
| ABBV-444 | Patient Eye Drop Experience (PEDE) Survey Scores at Day 30 (Visual Analog Scale) | The study eye drops have provided relief during conditions that lead to eye dryness (5 days) | 82.0 score on a scale | Standard Deviation 22.6 |