Phase 2
Completed N=89
Safety, PK and Efficacy Study of SJP-0132 in Subjects With Dry Eye Disease
Source: ClinicalTrials.gov NCT04139122 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
Apr 2023
Primary outcomePrimary: Number of Participants With Adverse Events by Severity in Each Cohort — 0; 0; 2; 0 Participants
Summary
This is the first study in humans to evaluate the effectiveness of SJP-0132 in the treatment of dry eye disease. This study will evaluate the safety, tolerability, efficacy, and pharmacokinetics of single- and multiple-dose regimens of SJP-0132 in subjects with dry eye disease
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adverse Events by Severity in Each Cohort |
0; 0; 2; 0; 0; 1 | — |
| PRIMARY Number of Subjects With Abnormal Changes in Laboratory Parameters, Vital Signs, and/or Physical and Ophthalmologic Observations in Each Cohort |
0; 0; 0; 0; 0; 0 | — |
| PRIMARY Maximum Plasma Concentration (Cmax) |
0.03773; 0.12940; 0.10228; 0.69275; 0.14077; 0.63273 | — |
| PRIMARY Area Under the Plasma Concentration-time Curve From Time 0 to Time of the Last Quantifiable Concentration (AUC0-last) |
0.28671; 1.02449; 0.85442; 5.15571; 0.32305; 1.14604 | — |
| PRIMARY Accumulation Ratio (Rac) After Multiple Dosing |
1.75758; 1.67083; 2.84759; 2.79157 | — |
| PRIMARY Change From Baseline in Eye Dryness Symptom (VAS) at 4hour on Day 29 |
-34.2; -26.3; -29.8 | — |
| PRIMARY Change From Baseline in Corneal Fluorescein Staining (CFS) Score at the Central Zone on Day 29 |
-1.1; -1.3; -1.2 | — |
| SECONDARY Change From Baseline in Eye Dryness Symptom by Visual Analog Scale (VAS) in Each Timepoints |
-14.3; -12.1; -8.0; -29.7; -22.3; -24.2 | — |
| SECONDARY Change From Baseline in Corneal Fluorescein Staining (CFS) Score at Total Zone in Each Timepoints |
-1.9; 0.6; -0.6; -3.9; -0.2; -2.3 | — |
| SECONDARY Change From Baseline in Conjunctival Lissamine Green Staining (CLGS) Score at Total Zone in Each Timepoints |
0.6; 1.7; 0.3; 0.5; 2.1; 1.6 | — |
| SECONDARY Change From Baseline in Lid Wiper Epitheliopathy Score in Each Timepoints |
-0.10; -0.33; -0.50; 0.08; -0.40; -0.33 | — |
| SECONDARY Change From Baseline in Tear Film Break-up Time (TFBUT) in Each Timepoints |
0.54; -0.04; 0.52; 1.26; 0; -0.08 | — |
| SECONDARY Change From Baseline in Ocular Surface Disease Index (OSDI) |
-24.19; -9.67; -28.17; -22.94; -9.94; -23.91 | — |
| SECONDARY Change From Baseline in Dry Eye Questionnaire 5 (DEQ-5) Scores |
-6.0; -4.9; -3.6 | — |
| SECONDARY Change in Matrix Metalloproteinase-9 (MMP-9) |
14; 2; 8; 6; 18; 12 | — |
Eligibility Criteria
Inclusion Criteria
- Body mass index (BMI) within 18.5 to 30.0 kg/m2 (inclusive) and body weight between 45 kg and 100 kg
- Generally healthy as determined by medical history, physical examinations, clinical laboratory examination, and ophthalmologic examinations performed at Screening
- Have a subject reported history of Dry Eye Disease in both eyes for at least 6 months prior to Screening
- Non-smoker or ex-smoker for >12 months
Exclusion Criteria
- Have clinically significant systemic or ophthalmic disease
- Has a positive serum pregnancy test at Screening or urine pregnancy test
- Have had significant blood loss or have donated or received one or more units (450 mL) of blood or plasma within 30 days before randomization
- Have used or anticipates use of any prescription or over-the-counter medication, including topical medications such as ophthalmic solutions, nasal drops or spray, vitamins, alternative and complementary medicines (including herbal formulations) within 14 days or 5 half-lives (whichever is longer) before randomization or at any time during the study
- Use or anticipates use of prescribed dry eye medications within 28 days prior to randomization or at any time during the study
- Have used or anticipates use CYP3A4 inducers, such as St. John's Wort, within 14 days before randomization or at any time during the study.
- Have consumed red wine, grapefruit or grapefruit juice, Seville oranges, star fruit, or any products containing these items, or any foods that may inhibit CYP3A4, within 48 hours before randomization and throughout the duration of the study
- Have a positive urine alcohol or urine drug test at Screening or Day -1
- Contact lens wearers who cannot discontinue the wear over the trial period
- Have undergone eye surgery (including laser surgery) within the last 12 months or whom the Investigator considers unsuitable
- Have a best corrected visual acuity (BCVA) worse than 20/100 in either eye
- History of permanent punctal occlusion (cautery or laser) or current use of punctal plugs
- Any corneal abnormality or disease which might impact normal tear film spreading
- Active or history of significant corneal disease
- Known allergy or sensitivity to fluorescein, lissamine green or any of the study medications
Other protocol-defined Inclusion/Exclusion Criteria may apply
Data sourced from ClinicalTrials.gov (NCT04139122). 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. Informational only — not medical advice.