Phase 2
N=120
Study Evaluating the Efficacy and Safety of PRT-2761 for the Treatment of Acute and Chronic Allergic Conjunctivitis
Allergic Conjunctivitis
Bottom Line
View on ClinicalTrials.gov: NCT03320434 ↗Enrolled (actual)
120
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcome: Primary: Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 — 2.573; 2.500; 1.217; 2.647 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- PRT-2761 0.5% (Drug); PRT-2761 1% (Drug); Patanol (Drug); Pred-forte (Drug); PRT-2761 0% (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- ORA, Inc.
- Primary completion
- Feb 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 1 |
2.573; 2.500; 1.217; 2.647; 2.677; 2.509 | — |
| PRIMARY Ocular Itching at 5, 7, and 10 Minutes Post CAC on Day 15 |
2.431; 2.611; 0.775; 2.527; 2.362; 2.602 | — |
| PRIMARY Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 1 |
1.282; 1.491; 1.592; 1.957; 1.411; 1.526 | — |
| PRIMARY Conjunctival Redness at 7, 15, and 20 Minutes Post CAC on Day 15 |
1.723; 2.056; 1.242; 1.973; 1.920; 2.176 | — |
Summary
To evaluate the efficacy and safety of two concentrations of PRT-2761 as a topical ophthalmic solution for the treatment of the signs and symptoms of acute and chronic allergic conjunctivitis.
Eligibility Criteria
Inclusion Criteria
- be at least 18 years old
- be willing and able to avoid all disallowed medications and contact lenses
- must have a pregnancy test if of childbearing potential
- must be able to read an eye chart from 10 feet away
Exclusion Criteria
- must not have any allergies to the study medications
- must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
- must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial
Data sourced from ClinicalTrials.gov (NCT03320434). 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.