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A Clinical Study to Assess the Efficacy and Safety of SED80 for Use in Cataract Surgery

I

iDrop

Status and phase

Completed
Phase 2

Conditions

Cataract in Inflammatory Ocular Disorders

Treatments

Drug: Placebo Dose 2
Drug: Placebo Dose 1
Drug: Dexamethasone Dose 2
Drug: Dexamethasone Dose 1

Study type

Interventional

Funder types

Industry

Identifiers

Details and patient eligibility

About

Patients at least 40 years of age who are undergoing cataract surgery will be randomized to receive treatment with one of four groups of dexamethasone ophthalmic suspension or placebo eye drops to determine if the drops decrease inflammation and pain inside the eye and are safe after cataract surgery.

Full description

"Patients undergoing traditional cataract surgery routinely develop inflammation and pain. This study will evaluate 4 arms of either dexamethasone or placebo.

Enrollment

60 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing traditional cataract surgery.

Exclusion criteria

  • Patients with unusual ocular conditions.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

60 participants in 4 patient groups, including a placebo group

Dexamethasone Dose 1
Active Comparator group
Treatment:
Drug: Dexamethasone Dose 1
Dexamethasone Dose 2
Active Comparator group
Treatment:
Drug: Dexamethasone Dose 2
Placebo Dose 1
Placebo Comparator group
Treatment:
Drug: Placebo Dose 1
Placebo Dose 2
Placebo Comparator group
Treatment:
Drug: Placebo Dose 2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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