Phase 2
N=369
A Phase 2b Study Evaluating the Safety and Efficacy of AR-15512 Ophthalmic Solution for the Treatment of Dry Eye Disease
Dry Eye Disease
Bottom Line
View on ClinicalTrials.gov: NCT04498182 ↗Enrolled (actual)
369
Serious AEs
0.4%
Results posted
Aug 2024
Primary outcome: Primary: Least Squares Mean Change From Baseline in Pre-CAE (Controlled Adverse Environment) Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28 — -15.3; -11.0; -11.9 millimeter (mm) — p=0.2305
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AR-15512 Ophthalmic Solution (Drug); AR-15512 Ophthalmic Solution Vehicle (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- All
- Sponsor
- Aerie Pharmaceuticals
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Least Squares Mean Change From Baseline in Pre-CAE (Controlled Adverse Environment) Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28 |
-15.3; -11.0; -11.9 | 0.2305 |
| PRIMARY Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 28 |
2.2; 3.0; 2.7 | 0.4936 |
| SECONDARY Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 28 |
57.8; 62.1; 61.2 | 0.2305 |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 84 |
-20.6; -13.3; -13.6 | 0.0281 sig |
| SECONDARY Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 84 |
52.4; 59.7; 59.4 | 0.0281 sig |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Anesthetized Schirmer Test Score at Day 84 |
2.9; 3.2; 2.9 | 0.9846 |
| SECONDARY Least Squares Mean Pre-CAE Anesthetized Schirmer Test Score at Day 84 |
7.9; 8.2; 7.9 | 0.9846 |
| SECONDARY Least Squares Mean Pre-CAE Anesthetized Schirmer Test Score at Day 28 |
7.2; 7.9; 7.7 | 0.4936 |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 84 |
-18.3; -12.6; -12.4 | 0.0786 |
| SECONDARY Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 84 |
36.1; 41.8; 42.1 | 0.0786 |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 28 |
-11.6; -6.6; -6.6 | 0.1153 |
| SECONDARY Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 28 |
43.0; 48.0; 48.0 | 0.1153 |
| SECONDARY Least Squares Mean Change From Baseline in Post-CAE Pain Score on a Visual Analogue Scale at Day 84 |
-17.6; -8.9; -12.1 | 0.1518 |
| SECONDARY Least Squares Mean Post-CAE Pain Score on a Visual Analogue Scale at Day 84 |
50.0; 58.7; 55.5 | 0.1518 |
| SECONDARY Least Squares Mean Change From Baseline in Post-CAE Pain Score on a Visual Analogue Scale at Day 28 |
-7.5; -7.2; -6.4 | 0.7560 |
| SECONDARY Least Squares Mean Post-CAE Pain Score on a Visual Analogue Scale at Day 28 |
59.7; 60.0; 60.8 | 0.7560 |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 28 |
-12.9; -9.3; -5.0 | 0.0005 sig |
| SECONDARY Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 28 |
62.8; 66.5; 70.8 | 0.0005 sig |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 84 |
-17.2; -9.5; -8.3 | 0.0015 sig |
| SECONDARY Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 84 |
58.6; 66.3; 67.5 | 0.0015 sig |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 28 |
-11.3; -8.2; -7.8 | 0.1520 |
| SECONDARY Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 28 |
63.4; 66.5; 66.9 | 0.1520 |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 84 |
-17.1; -11.5; -10.8 | 0.0302 sig |
| SECONDARY Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 84 |
57.4; 63.0; 63.7 | 0.0302 sig |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 14 |
-10.1; -8.2; -10.7 | 0.8166 |
| SECONDARY Mean Change From Baseline in Pre-CAE Ora Calibra® Ocular Discomfort Score (ODS) at Day 28 |
-0.4; -0.4; -0.3 | 0.3365 |
| SECONDARY Mean Change From Baseline in Pre-CAE Ora Calibra® Ocular Discomfort Score (ODS) at Day 84 |
-0.8; -0.5; -0.5 | 0.1557 |
| SECONDARY Least Squares Mean Pre-CAE Ocular Discomfort Score (ODS) on a Visual Analogue Scale at Day 14 |
63.0; 64.8; 62.4 | 0.8166 |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Pain Score on a Visual Analogue Scale at Day 14 |
-4.3; -1.8; -6.1 | 0.5215 |
| SECONDARY Least Squares Mean Pre-CAE Pain Score on a Visual Analogue Scale at Day 14 |
50.3; 52.8; 48.5 | 0.5215 |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Global SANDE Questionnaire Score at Day 14 |
-7.4; -5.9; -2.9 | 0.0254 sig |
| SECONDARY Least Squares Mean Pre-CAE Global SANDE Questionnaire Score at Day 14 |
68.3; 69.8; 72.8 | 0.0254 sig |
| SECONDARY Least Squares Mean Change From Baseline in Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 14 |
-8.8; -4.9; -4.9 | 0.0573 |
| SECONDARY Least Squares Mean Pre-CAE Eye Dryness Score on a Visual Analogue Scale at Day 14 |
65.7; 69.7; 69.7 | 0.0573 |
| SECONDARY Percentage of Subjects With a Baseline Anesthetized Schirmer Score Equal to or Less That 5 mm That Achieved an Anesthetized Schirmer Score of Equal to or Greater Than 10 mm at Day 84 |
16.5; 13.2; 12.1 | 0.3068 |
| SECONDARY Percentage of Subjects With a Baseline Anesthetized Schirmer Score Equal to or Less That 5 mm That Achieved an Anesthetized Schirmer Score of Equal to or Greater Than 10 mm at Day 28 |
10.3; 9.5; 13.6 | 0.2867 |
| SECONDARY Percentage of Subjects That Achieved at Least a 10 mm Increase in Pre-CAE Anesthetized Schirmer Score Relative to Baseline at Day 28 |
11.1; 9.5; 7.6 | 0.4375 |
| SECONDARY Percentage of Subjects That Achieved at Least a 10 mm Increase in Pre-CAE Anesthetized Schirmer Score Relative to Baseline at Day 84 |
7.8; 13.2; 11.2 | 0.5046 |
Summary
This is a Phase 2b, multicenter, vehicle-controlled, double-masked, randomized study. All subjects enrolled will have dry eye disease. The study consists of Screening and Baseline visits to determine eligibility, followed by efficacy assessments at Day 14 (Visit 3), 28 (Visit 4) and 84 (Visit 5/Study Exit). Safety will be assessed at all study visits.
Eligibility Criteria
Key Inclusion Criteria
- Previous history of dry eye disease (DED) within the previous 6 months;
- Have used and/or desired to use artificial tears for DED symptoms within 2 months prior to the Screening visit;
- Signs and symptoms of DED at the Screening and Baseline visits;
- Best Corrected Visual Acuity (BCVA) of 20/200 (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits;
- 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, likely interfere with the interpretation of the study results or subject safety;
- Current evidence of other significant ophthalmic diseases which, in the opinion of the investigator, may interfere with study findings or interpretation;
- Use of contact lenses in either eye within 7 days prior to the Screening visit or planned use during the study;
- Regular use of ocular medications or nutritional supplements as specified in the protocol within 30 days prior to the Screening visit;
- Positive pregnancy test at Screening or Baseline visits or currently breastfeeding.
- Other protocol-specified exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT04498182). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.