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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABBV-444 | Experimental | Participants will administer 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABBV-444 | Drug | Lubricant Eye drops |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Canyon City Eyecare /ID# 253652 | Azusa | California | 91702 | United States |
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABBV-444 | Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days. ABBV-444: Lubricant Eye drops |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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ITT population: Includes all enrolled participants who received at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | ABBV-444 | Participants administered 1-2 drops of ABBV-444 in each eye as needed, but minimally twice a day for 30 days. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline to Day 30 |
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All-cause mortality and adverse event tables include events reported from enrollment to end of study. Safety events (per protocol) were collected from enrollment through the 30 day treatment period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABBV-444 | Participants administered 1-2 drops of ABBV-444 in each eye as needed but minimally twice a day for 30 days. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2023 | Jun 27, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| Day 30 |
| 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. | Baseline (T0) to 5 minutes (T5) |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | 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. | Posted | Mean | Standard Deviation | score on a scale | Day 30 |
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| 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. | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline (T0) to 5 minutes (T5) |
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| 0 |
| 40 |
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| 40 |
| 0 |
| 40 |
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
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| Did not experience much blurry/fluctuating vision after putting study eye drops in my eyes (5 mins) |
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| Study eye drops provided immediate comfort to my eye dryness when putting in my eyes (5 minutes) |
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| The study eye drops are very soothing for my eye dryness (30 minutes) |
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| The study eye drops did not feel sticky (30 minutes) |
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| The study eye drops continued to provide relief of my eye discomfort (30 minutes) |
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| The study eye drops continued to provide comfort to my eye dryness (30 minutes) |
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| The study eye drops provided relief of my eye dryness day and night (24 hours) |
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| The study eye drops provided comfort to my eye dryness day and night (24 hours) |
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| The study eye drops provided lasting relief of my eye dryness (5 days) |
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| The study eye drops have provided relief during conditions that lead to eye dryness (5 days) |
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