Comparative Study to Evaluate ISV-305 Compared to Vehicle for the Treatment of Inflammation and Pain Associated With Cataract Surgery


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Verified June 2017 by InSite Vision

Sponsor:

Information provided by (Responsible Party):

InSite Vision

ClinicalTrials.gov Identifier:

NCT03192137

First received: June 15, 2017

Last updated: June 15, 2017

Last verified: June 2017

The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of inflammation and pain associated with cataract surgery.

Inflammation and Pain Associated With Cataract Surgery Drug: ISV-305
Other: Vehicle
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Multicenter, Double-masked Study to Compare the Ocular Safety, Tolerability, and Efficacy of ISV-305 (0.1% Dexamethasone in DuraSite® 2) to DuraSite 2 Vehicle for the Treatment of Inflammation and Pain Associated With Cataract Surgery

Primary Outcome Measures:

Estimated Enrollment: 240
Anticipated Study Start Date: August 2017
Estimated Study Completion Date: August 2018
Estimated Primary Completion Date: April 2018 (Final data collection date for primary outcome measure)
Experimental: ISV-305 Drug: ISV-305

Dexamethasone in DuraSite® 2 twice daily for 16 days

Placebo Comparator: Vehicle Other: Vehicle

Placebo twice daily for 16 days

Ages Eligible for Study:   17 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Are at least 17 years of age
  • Are scheduled for uncomplicated unilateral cataract surgery
  • Signature of the subject or parent(s) or legally authorized representative on the Informed Consent Form, and when appropriate the minor’s assent in accordance with local regulations
  • Are willing and able to follow all instructions and attend all study visits
  • Are willing to avoid disallowed medication for the duration of the study
  • If female is of childbearing potential, agree to and submit a urine sample for pregnancy testing (prior to enrollment and at the end of the study) and use effective contraception for the duration of the study
  • Additional inclusion criteria also apply

Exclusion Criteria:

  • Have known sensitivity or poor tolerance to any component of the study drugs
  • Have any sign of iritis or scleritis in the study eye
  • Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation in the study eye
  • Have any active or chronic/recurrent ocular or systemic disease that is uncontrolled and likely to affect wound healing (e.g., diabetes mellitus, systemic connective tissue disease, severe atopic disease)
  • Have known blood dyscrasia or bone marrow suppression
  • Have any active corneal pathology in the study eye
  • Have had radial keratotomy, corneal transplant, or LASIK in the study eye within the last 2 years
  • Be currently pregnant, nursing, or planning a pregnancy; or have a positive urine pregnancy test
  • Have prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
  • Have 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
  • Use of any medication the investigator feels may interfere with the study parameters
  • Additional exclusion criteria also apply

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03192137

InSite Vision

Responsible Party: InSite Vision
ClinicalTrials.gov Identifier: NCT03192137     History of Changes
Other Study ID Numbers: C-13-305-002
Study First Received: June 15, 2017
Last Updated: June 15, 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Inflammation
Cataract
Pathologic Processes
Lens Diseases
Eye Diseases
Dexamethasone
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents

ClinicalTrials.gov processed this record on June 19, 2017