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

Phase 2

Withdrawn

• Conditions: Dry Eye Disease
• Interventions: Drug: ISV 101

• Registration Number: NCT01478555
• Lead Sponsor: Sun Pharmaceutical Industries Limited

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-10-24
• Study First Submitted QC: 2011-11-21
• Study First Posted: 2011-11-23
• Study Start: 2018-01
• Primary Completion: 2018-07
• Study Completion: 2019-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-18
• Last Update Posted: 2021-11-19

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DuraSite	ISV 101	-
Vehicle	ISV 101	-
Dose 1 of Bromfenac in DuraSite	ISV 101	-
Dose 2 of Bromfenac in DuraSite	ISV 101	-
Dose 3 of Bromfenac in DuraSite	ISV 101	-

Primary Outcome Measures

Name	Time	Method
Improvement in OSDI Scoring	Week 8
Improvement in Corneal Fluorescein Staining	Week 8