Phase 3
Completed N=600
LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery
Cataract · Postoperative Pain · Ocular Inflammation
Source: ClinicalTrials.gov NCT02786901 ↗
Enrolled (actual)
600
Serious AEs
0.2%
Results posted
Apr 2020
Primary outcomePrimary: Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8) — 40; 52; 61 Participants
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8) |
40; 52; 61 | — |
| PRIMARY Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8) |
99; 151; 151 | — |
| SECONDARY Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells in the Study Eye at Final On-treatment Visit. |
67; 82; 94 | — |
| SECONDARY Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Final On-Treatment Visit |
122; 168; 170 | — |
| SECONDARY Number of Participants With Complete Resolution of Anterior Chamber (AC) Flare in the Study Eye at Final On-Treatment Visit |
107; 143; 153 | — |
| SECONDARY Number of Participants With Complete Resolution of Both Anterior Chamber (AC) Cells and AC Flare in the Study Eye at Final On-Treatment Visit |
66; 82; 92 | — |
| SECONDARY Change From Baseline in Summed Anterior Chamber (AC) Cell and Flare Scores at Final On-Treatment Visit |
-1.2; -2.0; -2.1 | — |
| SECONDARY Number of Participants With Treatment Failure at Visit 5 (Postoperative Day 8) |
62; 23; 20 | — |
Eligibility Criteria
Key Inclusion Criteria
- Be 18 years or older on the date the Informed Consent Form (ICF) is signed and with the capacity to provide voluntary informed consent.
- Be able to read, understand, and provide written informed consent on the Institutional Review Board (IRB)/Ethics Committee (EC) approved ICF and provide Health Insurance Portability and Accountability Act (HIPAA) authorization.
- Be willing and able to comply with all treatment and follow-up/study procedures.
- Be a candidate for routine, uncomplicated cataract surgery (phaco-emulsification with posterior chamber intraocular lens [IOL] implantation, not combined with any other surgery).
- In the Investigator's opinion, have potential postoperative pin-holed Snellen visual acuity (VA) of at least 20/200 in the study eye at Visit 1 (Screening) and at least 20/200 in the fellow eye.
Key Exclusion Criteria
- Have a severe/serious ocular condition or history/presence of chronic generalized systemic disease that the Investigator feels might increase the risk to the subject or confound the result(s) of the study.
- Be a female subject who is pregnant or breastfeeding.
- Be monocular (fellow eye is nonfunctional or fellow eye's pinhole vision is worse than Snellen 20/200).
- Have had ocular surgery (including laser surgery) in the study eye within 3 months or in the fellow eye within 2 weeks prior to Visit 1 (Screening).
Data sourced from ClinicalTrials.gov (NCT02786901). 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.