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

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Dry Eye Disease
• Intervention / Treatment: Drug: ISV 101

• Study Type: Interventional
• Phase: Phase 2

Participation Criteria

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:

1. Volunteers 18 years of age and older who have a diagnosis of moderate to severe dry eye disease.
2. 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
3. Signature of the subject on the Informed Consent Form
4. Willing to avoid disallowed medication for the duration of the study.
5. Able to self-administer study drug (or have a caregiver available to instill all doses of study drug)
6. Able and willing to follow study instructions
7. Additional inclusion criteria also apply

Exclusion Criteria:

1. 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).
2. Use of contact lenses during the study.
3. Use of any concomitant topical ocular medications except for artificial tears during the dosing period
4. Presence or history of treatment with systemic immunosuppressive or chemotherapeutic agents.
5. Prior or anticipated concurrent use of an investigational product or device that could confound the findings about Dry Eye in the study eye.
6. 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
7. Known hypersensitivity to any component of the study drug or procedural medications
8. Participation in any other clinical trial within 30 days prior to screening
9. Known hypersensitivity to NSAIDS
10. Any active corneal epithelial/stromal pathology noted in the study eye at the screening visit
11. Any history of corneal surgery (including corneal crosslinking, radial keratotomy, corneal transplant, or LASIK)
12. Cataract surgery within the past year.
13. Known contraindication to the study drugs or any of their components

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Improvement in Corneal Fluorescein Staining	Week 8
Improvement in OSDI Scoring	Week 8

Collaborators and Investigators

• Sponsor: Sun Pharmaceutical Industries Limited

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): January 1, 2018
• Primary Completion (ANTICIPATED): July 1, 2018
• Study Completion (ANTICIPATED): January 1, 2019

Study Registration Dates

• First Submitted: October 24, 2011
• First Submitted That Met QC Criteria: November 21, 2011
• First Posted (ESTIMATE): November 23, 2011

Study Record Updates

• Last Update Posted (ACTUAL): November 19, 2021
• Last Update Submitted That Met QC Criteria: November 18, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: Dry Eye
• Additional Relevant MeSH Terms: Lacrimal Apparatus Diseases; Keratoconjunctivitis; Conjunctivitis; Conjunctival Diseases; Keratitis; Corneal Diseases; Eye Diseases; Dry Eye Syndromes; Keratoconjunctivitis Sicca
• Other Study ID Numbers: C-10-101-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No