Phase 3
Completed N=508
Dose Ranging Study to Assess the Efficacy and Safety of Voclosporin Ophthalmic Solution in Subjects With Dry Eye Syndrome
Dry Eye Disease · Keratoconjunctivitis Sicca
Source: ClinicalTrials.gov NCT04147650 ↗
Enrolled (actual)
508
Serious AEs
1.8%
Results posted
Dec 2021
Primary outcomePrimary: Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) — 12; 10; 13; 6 participants — p=0.1352
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
A Multi-Center, Phase 2/3, Randomized, Double-Masked, Parallel-Group, Vehicle-Controlled, Clinical Trial to Assess the Safety and Efficacy of Voclosporin Ophthalmic Solution (0.05%, 0.10%, 0.20%) Compared to Vehicle in Subjects with Dry Eye Syndrome.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With a ≥10 mm Increase From Baseline in Schirmer Tear Test (STT) |
12; 10; 13; 6 | 0.1352 |
| SECONDARY Change From Baseline in Eye Dryness |
-10.6; -9.3; -5.0; -7.0 | 0.3604 |
Eligibility Criteria
Inclusion Criteria
- Be at least 18 years of age.
- Have a documented history of Dry Eye prior to Visit 1.
- Willing and able to follow protocol procedures and instructions.
Exclusion criteria
- Have undergone cataract or LASIK surgery within 1 year prior to Visit 1.
- Recent or current evidence of infection or inflammation in either eye.
- Current evidence of blepharitis, other meibomian gland dysfunction, conjunctivitis or history of herpes simplex or zoster keratitis in either eye.
- Have used any investigational drug or device within 30 days prior to Visit 1.
- Have used ophthalmic drugs (any topical eye medications) including prescription medication and over the counter (OTC) agents on the date of Visit 1.
- Have worn contact lenses 24 hours prior to Visit 1.
- Have used Xiidra® (lifitegrast) within 14 days prior to Visit 1.
- Have used Calcineurin Inhibitors (CNIs) such as Restasis® (cyclosporin ophthalmic emulsion) or CequaTM within 30 days prior to Visit 1.
Data sourced from ClinicalTrials.gov (NCT04147650). 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.