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Also known as Reference Listed Drug (RLD)
Reference Listed Drug · 1 trial · 1 indication
PK for loteprednol etabonate concentrations in aqueous humor. Area under the concentration versus time curve.
PK for loteprednol etabonate concentrations in aqueous humor. Maximum observed mean concentration in aqueous humor over the time span specified.
| Arm | Type | Description |
|---|---|---|
| Generic Loteprednol Etabonate - RLD | EXPERIMENTAL | Period 1: Generic Loteprednol Etabonate - Period 2 (Cross-Over): Reference Listed Drug (RLD) |
| RLD - Generic Loteprednol Etabonate | ACTIVE_COMPARATOR | Period 1: Reference Listed Drug (RLD) - Period 2 (Cross-Over): Generic Loteprednol Etabonate |
| Name | Type | Description |
|---|---|---|
| Generic Loteprednol Etabonate | DRUG | Drug |
| Reference Listed Drug (RLD) | DRUG | Drug |
Inclusion Criteria: * Subjects must have a need for cataract surgery in both eyes and can be dosed in the surgical eyes. * Non-pregnant, non-lactating females, or women who are post-menopausal (defined as at least 12 months natural, spontaneous amenorrhea), or are naturally or surgically sterile (h...
Reference Listed Drug is being studied for inflammation following ocular surgery. It is an investigational small molecule developed by Novartis AG. The clinical program has focused on adults undergoing bilateral cataract surgery, evaluating the drug in a Phase 1 trial conducted in Canada.
Reference Listed Drug is developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor of the clinical program evaluating the drug for inflammation following ocular surgery.
Reference Listed Drug is in Phase 1 clinical development. It is an investigational therapy and has not been approved by the FDA. The Phase 1 program includes one completed trial with 381 participants, and no active trials are currently listed.
Reference Listed Drug has been evaluated in the trial NCT03531697, titled Study of Loteprednol Etabonate in Adults Undergoing Bilateral Cataract Surgery. The Phase 1 trial enrolled 381 adults in Canada and is completed. It was randomized and active-controlled, without blinding.
Yes. Reference Listed Drug is also known as Reference Listed Drug (RLD). RLD is the abbreviated form used in regulatory and scientific contexts. Both names refer to the same investigational small molecule being developed by Novartis AG for inflammation following ocular surgery.