MedDataX Logo

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

NCT ID: NCT01478555

Last Updated: 2021-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-31

Study Completion Date

2019-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Disease

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Dry Eye

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dose 1 of Bromfenac in DuraSite

Group Type EXPERIMENTAL

ISV 101

Intervention Type DRUG

Bromfenac in DuraSite

Dose 2 of Bromfenac in DuraSite

Group Type EXPERIMENTAL

ISV 101

Intervention Type DRUG

Bromfenac in DuraSite

Dose 3 of Bromfenac in DuraSite

Group Type EXPERIMENTAL

ISV 101

Intervention Type DRUG

Bromfenac in DuraSite

DuraSite

Group Type ACTIVE_COMPARATOR

ISV 101

Intervention Type DRUG

Bromfenac in DuraSite

Vehicle

Group Type ACTIVE_COMPARATOR

ISV 101

Intervention Type DRUG

Bromfenac in DuraSite

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ISV 101

Bromfenac in DuraSite

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Sun Pharmaceutical Industries Limited

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

C-10-101-001

Identifier Type: -

Identifier Source: org_study_id