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Study to See How Well an Eye Drop, SURF-201, Works and What Side Effects There Are in Cataract Surgery Subjects

NCT04324359 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 91

Last updated 2025-01-15

Study results available
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Summary

SURF-201 is being studied for the treatment of eye inflammation and pain in people who are undergoing cataract surgery. SURF-201 is an investigational drug (which means the study drug is currently being tested) in the form of a sterile eye drop.

The purpose of this research study is to see how well SURF-201 works and what side effects there are, and to compare it with Vehicle (placebo). This study will involve about 80 study participants at several different research sites in the United States.

Conditions

  • Post-surgical Ocular Inflammation
  • Post-surgical Ocular Pain

Interventions

DRUG

SURF-201

One drop twice daily (BID) in the study eye for 16 days.

DRUG

Placebo

One drop twice daily (BID) in the study eye for 16 days.

Sponsors & Collaborators

  • Surface Ophthalmics, Inc.

    lead INDUSTRY

Principal Investigators

  • Kamran Hosseini, MD, PhD · Surface Ophthalmics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-03-03
Primary Completion
2020-11-03
Completion
2020-11-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04324359 on ClinicalTrials.gov