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A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease (ISV-101)

Primary Purpose

Dry Eye Disease

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

ISV 101

About this trial

This is an interventional basic science trial for Dry Eye Disease focused on measuring Dry Eye

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Volunteers 18 years of age and older who have a diagnosis of moderate to severe dry eye disease.
Negative pregnancy test prior to the conduct of any protocol-specific procedure. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
Signature of the subject on the Informed Consent Form
Willing to avoid disallowed medication for the duration of the study.
Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
Able and willing to follow study instructions
Additional inclusion criteria also apply

Exclusion Criteria:

Females who are pregnant or nursing. Females of childbearing potential (not surgically sterilized or postmenopausal) may not participate in the study if they do not agree to use adequate birth control methods for the duration of the study).
Use of contact lenses during the study.
Use of any concomitant topical ocular medications except for artificial tears during the dosing period
Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents.
Prior or anticipated concurrent use of an investigational product or device that could confound the findings about Dry Eye in the study eye.
A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
Known hypersensitivity to any component of the study drug or procedural medications
Participation in any other clinical trial within 30 days prior to screening
Known hypersensitivity to NSAIDS
Any active corneal epithelial/stromal pathology noted in the study eye at the screening visit
Any history of corneal surgery (including corneal crosslinking, radial keratotomy, corneal transplant, or LASIK)
Cataract surgery within the past year.
Known contraindication to the study drugs or any of their components

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Dose 1 of Bromfenac in DuraSite

Dose 2 of Bromfenac in DuraSite

Dose 3 of Bromfenac in DuraSite

DuraSite

Vehicle

Arm Description

Outcomes

Primary Outcome Measures

Improvement in Corneal Fluorescein Staining

Improvement in OSDI Scoring

Secondary Outcome Measures

Full Information

NCT ID

NCT01478555

First Posted

October 24, 2011

Last Updated

November 18, 2021

Sponsor

Sun Pharmaceutical Industries Limited

1. Study Identification

Unique Protocol Identification Number

NCT01478555

Brief Title

A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease

Acronym

ISV-101

Official Title

A Dose-Finding Study To Compare The Safety, Tolerability, And Efficacy Of Differing Dosing Regimens Of ISV-101 (Bromfenac In DuraSite® Ophthalmic Solution) To Vehicle And DuraSite Alone In Dry Eye Disease Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Withdrawn

Why Stopped

Project postponed

Study Start Date

January 2018 (Anticipated)

Primary Completion Date

July 2018 (Anticipated)

Study Completion Date

January 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-101 (Bromfenac in DuraSite® ophthalmic solution) compared to Vehicle and DuraSite alone.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Dry Eye Disease

Keywords

Dry Eye

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Dose 1 of Bromfenac in DuraSite

Arm Type

Experimental

Arm Title

Dose 2 of Bromfenac in DuraSite

Arm Type

Experimental

Arm Title

Dose 3 of Bromfenac in DuraSite

Arm Type

Experimental

Arm Title

DuraSite

Arm Type

Active Comparator

Arm Title

Vehicle

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

ISV 101

Intervention Description

Bromfenac in DuraSite

Primary Outcome Measure Information:

Title

Improvement in Corneal Fluorescein Staining

Time Frame

Week 8

Title

Improvement in OSDI Scoring

Time Frame

Week 8

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Volunteers 18 years of age and older who have a diagnosis of moderate to severe dry eye disease. Negative pregnancy test prior to the conduct of any protocol-specific procedure. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months Signature of the subject on the Informed Consent Form Willing to avoid disallowed medication for the duration of the study. Able to self-administer study drug (or have a caregiver available to instill all doses of study drug) Able and willing to follow study instructions Additional inclusion criteria also apply Exclusion Criteria: Females who are pregnant or nursing. Females of childbearing potential (not surgically sterilized or postmenopausal) may not participate in the study if they do not agree to use adequate birth control methods for the duration of the study). Use of contact lenses during the study. Use of any concomitant topical ocular medications except for artificial tears during the dosing period Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents. Prior or anticipated concurrent use of an investigational product or device that could confound the findings about Dry Eye in the study eye. A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation Known hypersensitivity to any component of the study drug or procedural medications Participation in any other clinical trial within 30 days prior to screening Known hypersensitivity to NSAIDS Any active corneal epithelial/stromal pathology noted in the study eye at the screening visit Any history of corneal surgery (including corneal crosslinking, radial keratotomy, corneal transplant, or LASIK) Cataract surgery within the past year. Known contraindication to the study drugs or any of their components

12. IPD Sharing Statement

Learn more about this trial

A Dose-Finding Study Comparing InSite Vision, Inc. 101 to Vehicle and DuraSite Alone for Dry Eye Disease

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