Safety and Efficacy of an Ophthalmic Solution in Dry Eye Disease

August 25, 2020 updated by: Bausch & Lomb Incorporated
The purpose of this study is to investigate the safety and efficacy of an ophthalmic solution in dry eye disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

38

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Irvine, California, United States, 92618
        • ISTA Pharmaceuticals, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects 18 years of age or older

Exclusion Criteria:

  • No active ocular conditions of disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: bromfenac ophthalmic solution 0.06%
bromfenac ophthalmic solution 0.06% bilaterally twice a day
Drug: bromfenac ophthalmic solution 0.06%
bromfenac ophthalmic solution 0.06% bilaterally twice a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline in Average Lissamine Green Staining in the Study Eye
Time Frame: Baseline, Day 42
Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for total scoring ranged from 0 to 18 units summed across all 6 conjunctival regions, with a higher score suggesting a more dry eye condition. An average of the 6 areas was computed, providing an average score of 0-3 units. The study eye utilized for analysis was selected by pre-specified criteria.
Baseline, Day 42
Percentage of Participants With at Least One Adverse Event
Time Frame: 52 days
52 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Change From Baseline to Worst Region in Lissamine Green Staining in the Study Eye
Time Frame: Baseline, 42 days
Lissamine green staining was assessed for both eyes at each study visit. The Investigator inserted a lissamine green staining strip into the inferior conjunctival cul-de-sac. Staining density for each of the 6 regions of the conjunctiva (temporal, superior temporal, inferior temporal, superior nasal, inferior nasal, and nasal) was graded from 0 to 3 approximately 2.5 minutes after strip instillation according to the National Eye Institute (NEI) chart and grid. The scale for worst region of Lissamine Green staining ranged from 0 to 3 units, with a higher score suggesting a more dry eye condition.The worst region of lissamine green staining was determined at the baseline visit. The study eye utilized for analysis was selected based on pre-specified criteria.
Baseline, 42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch & Lomb Incorporated

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 13, 2008

Primary Completion (ACTUAL)

January 14, 2009

Study Completion (ACTUAL)

January 14, 2009

Study Registration Dates

First Submitted

September 19, 2008

First Submitted That Met QC Criteria

September 22, 2008

First Posted (ESTIMATE)

September 25, 2008

Study Record Updates

Last Update Posted (ACTUAL)

September 14, 2020

Last Update Submitted That Met QC Criteria

August 25, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL-S&E-0417082-P

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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