Phase 3
N=181
Study to Evaluate the Safety for the Treatment of Inflammation Associated With Cataract Surgery
Cataract
Bottom Line
View on ClinicalTrials.gov: NCT02547623 ↗Enrolled (actual)
181
Serious AEs
1.7%
Results posted
Jun 2018
Primary outcome: Primary: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) — 53; 13; 1; 0 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Dexamethasone (Drug); Prednisolone (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- ICON Bioscience Inc
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-Emergent Adverse Events (TEAEs) |
53; 13; 1; 0; 72; 42 | — |
| SECONDARY Intraocular Pressure Measurement |
15.1; 14.4; 19.1; 17.5; 15.0; 15.1 | — |
| SECONDARY Visual Acuity in Study Eye |
.292; .355; .249; .327; .073; .073 | — |
| SECONDARY Slit Lamp Biomicroscopy - Conjunctival Hyperemia Grade |
124; 55; 1; 0; 1; 0 | — |
| SECONDARY Slit Lamp Biomicroscopy - Cornea Edema Grade |
126; 54; 0; 0; 0; 0 | — |
| SECONDARY Summary of Concomitant Medications Used in the Study Eye or Both Eyes |
124; 55; 1; 1; 4; 1 | — |
| SECONDARY Changes in the Corneal Endothelial Cell Count |
2483.66; 2398.33; 2141.77; 2106.39; -334.60; -288.83 | — |
| SECONDARY Optic Disc Cup-disc Ratio for the Study Eye |
.31; .32; .31; .33 | — |
| SECONDARY Dilated Opthalmoscopy Findings - Optic Disc (Study Eye) |
115; 52; 2; 1; 9; 2 | — |
| SECONDARY Dilated Opthalmoscopy Findings - Retina (Study Eye) |
120; 51; 5; 4; 1; 0 | — |
| SECONDARY Dilated Opthalmoscopy Findings - Macula (Study Eye) |
109; 44; 15; 11; 2; 0 | — |
| SECONDARY Dilated Opthalmoscopy Findings - Choroid (Study Eye) |
124; 54; 0; 0; 2; 1 | — |
| SECONDARY Dilated Opthalmoscopy Findings - Vitreous (Study Eye) |
104; 49; 21; 5; 1; 1 | — |
Summary
The study is a prospective, randomized, parallel-design, multicenter trial in patients ≥40 years of age undergoing cataract surgery. Patients who meet all inclusion and no exclusion criteria will be randomized to 1 of 2 treatment groups
* A single 5 mcl anterior chamber injection of IBI 10090, 103.4 mcg/mcl dexamethasone, equivalent dexamethasone dose: 517 mcg at the conclusion of cataract surgery or;
* Prednisolone acetate ophthalmic suspension 1% eye drops administered 1 drop 4 times daily (QID) for 3 weeks Safety will be assessed by adverse events (AEs), slit lamp biomicroscopy, fundus examination, intraocular pressure (IOP), visual acuity, and specular microscopy endothelial cell count.
Eligibility Criteria
Inclusion Criteria
- undergoing cataract surgery
Exclusion Criteria
- glaucoma patient, pregnancy, allergy to dexamethasone
Data sourced from ClinicalTrials.gov (NCT02547623). 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.