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

Sponsor
iDrop, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04711213
Collaborator
(none)
60
Enrollment
1
Location
4
Arms
2
Actual Duration (Months)
29.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexamethasone Dose 1
  • Drug: Dexamethasone Dose 2
  • Drug: Placebo Dose 1
  • Drug: Placebo Dose 2
 Phase 2

Detailed Description

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

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Randomized to 2 active dosing groups and 2 corresponding dosing groupsRandomized to 2 active dosing groups and 2 corresponding dosing groups
Masking:
Single (Participant)
Masking Description:
Single Masked randomized study
Primary Purpose:
Treatment
Official Title:
A Phase 2 Clinical Study to Assess the Efficacy and Safety of SED80 for the Treatment of Inflammation and Pain Associated With Cataract Surgery
Actual Study Start Date :
Sep 14, 2020
Actual Primary Completion Date :
Oct 31, 2020
Actual Study Completion Date :
Nov 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dexamethasone Dose 1

Drug: Dexamethasone Dose 1
Dexamethasone ophthalmic suspension dose 1
Active Comparator: Dexamethasone Dose 2

Drug: Dexamethasone Dose 2
Dexamethasone ophthalmic suspension dose 2
Placebo Comparator: Placebo Dose 1

Drug: Placebo Dose 1
Placebo suspension dose 1
Placebo Comparator: Placebo Dose 2

Drug: Placebo Dose 2
Placebo suspension dose 2

Outcome Measures

Primary Outcome Measures

  1. Ocular inflammation [Day 8]

    Measuring Anterior Cell Count

Secondary Outcome Measures

  1. Ocular Pain [Day 8]

    Measuring patient ocular pain using an 11-point visual scale

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Patients undergoing traditional cataract surgery.
Exclusion Criteria:
  • Patients with unusual ocular conditions.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre De. Oftalmologia San Salvador El Salvador

Sponsors and Collaborators

  • iDrop, Inc.

Investigators

  • Principal Investigator: Gabriel Casada, MD, President - Centre De. Oftalmolgia

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
iDrop, Inc.
ClinicalTrials.gov Identifier:
NCT04711213
Other Study ID Numbers:
  • C-02
First Posted:
Jan 15, 2021
Last Update Posted:
Jan 15, 2021
Last Verified:
Sep 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Cataract
Dexamethasone
Dexamethasone acetate
BB 1101

Study Results

No Results Posted as of Jan 15, 2021