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

Sponsor

Sun Pharmaceutical Industries Limited (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT01478555

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Dry Eye Disease	Drug: ISV 101	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Basic Science

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

Anticipated Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Jul 1, 2018

Anticipated Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dose 1 of Bromfenac in DuraSite	Drug: ISV 101 Bromfenac in DuraSite
Experimental: Dose 2 of Bromfenac in DuraSite	Drug: ISV 101 Bromfenac in DuraSite
Experimental: Dose 3 of Bromfenac in DuraSite	Drug: ISV 101 Bromfenac in DuraSite
Active Comparator: DuraSite	Drug: ISV 101 Bromfenac in DuraSite
Active Comparator: Vehicle	Drug: ISV 101 Bromfenac in DuraSite

Outcome Measures

Primary Outcome Measures

Improvement in Corneal Fluorescein Staining [Week 8]
Improvement in OSDI Scoring [Week 8]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Sun Pharmaceutical Industries Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Sun Pharmaceutical Industries Limited

ClinicalTrials.gov Identifier:

NCT01478555

Other Study ID Numbers:

C-10-101-001

First Posted:

Nov 23, 2011

Last Update Posted:

Nov 19, 2021

Last Verified:

Nov 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Sun Pharmaceutical Industries Limited

Dry Eye

Additional relevant MeSH terms:

Dry Eye Syndromes

Keratoconjunctivitis Sicca

Eye Diseases

Study Results

No Results Posted as of Nov 19, 2021