CompletedPhase 3

LE Gel for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery

United States600 participantsStarted 2016-06

Plain-language summary

Loteprednol Etabonate Ophthalmic Gel, (BID and TID) versus Vehicle Group for the Treatment of Ocular Inflammation and Pain Following Cataract Surgery.

Who can participate

Age range18 Years

SexALL

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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.

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).

What they're measuring

Number of Participants With Complete Resolution of Anterior Chamber (AC) Cells at Visit 5 (Postoperative Day 8)

Timeframe: 8 days

Number of Participants With Complete Resolution of Ocular Pain in Study Eye at Visit 5 (Postoperative Day 8)

Timeframe: 8 days

Trial details

NCT IDNCT02786901

SponsorBausch & Lomb Incorporated

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-06-13

Results submitted2020-03-09

View on ClinicalTrials.gov More Cataract trials