2nd Study to Assess ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery

NCT03192150 | Completed Phase 3 Results FDA Drug

• 1 other identifier: C-16-305-003
• Study Type: interventional
• Target: 246
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Inflammation and Pain Associated With Cataract Surgery

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Anterior Chamber Cell Grade 0 in Study Eye at Day 15 (Last Observation Carried Forward) in the Modified Intent to Treat (mITT) Population

  Biomicroscopic measurement of anterior chamber cells was conducted in the surgery eye (study eye) by the same examiner from visit to visit whenever possible. A slit-lamp biomicroscope was used at x16 magnification with a 1 x 1 mm oblique high-intensity beam. Two cell counts were summed and divided by 2 to determine an average final anterior chamber cell count. This final cell count was converted to a grade: Grades 0, 1, 2, 3, 4 were assigned for cell counts of 0, 1 to 10, 11 to 20, 21 to 50, and \> 50, respectively. If the averaged count fell between two grades, the higher grade was selected (e.g., if the two counts were 10 and 11, the average of 10.5 fell into Grade 2). Missing anterior chamber cell grade at Day 15 was imputed by last non-missing scheduled post-baseline anterior chamber cell grade assessed prior to Day 15 (last observation carried forward).

  Day 15

Secondary Outcomes (1)

• Number of Participants Who Achieve a Pain Score of 0 on the Visual Analog Scale (VAS) (0-100 mm Scale) for Each Post-surgical Assessment at Days 1, 8, 15, 18, and 29

  Day 1 to Day 29

Study Arms (2)

ISV-305

EXPERIMENTAL

0.1% dexamethasone in DuraSite® 2

Drug: ISV-305

Vehicle

PLACEBO COMPARATOR

DuraSite® 2 vehicle

Other: Vehicle

Interventions

ISV-305 DRUG

Dexamethasone in DuraSite® 2 twice daily for 16 days

ISV-305

Vehicle OTHER

Vehicle twice daily for 16 days

Vehicle

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Male subjects whose female partners are not post-menopausal must agree to one of the following: 1) completely abstain from sexual intercourse, 2) use a barrier method (condoms) with spermicide during sexual intercourse for the duration of the study, 3) provide documentation for having had a vasectomy (with documented infertility)

You may not qualify if:

• 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

Sponsors & Collaborators

• Sun Pharmaceutical Industries Limited: lead

Study Sites (1)

Clinical Research Center

Austin, Texas, 78731, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Head, Clinical development
• Organization: Sun Pharma Global FZE

Clinical.Trials@sparcmail.com

91 2266455645

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2017
• First Posted: June 19, 2017
• Study Start: January 3, 2018
• Primary Completion: November 18, 2019
• Study Completion: November 18, 2019
• Last Updated: November 19, 2021
• Results First Posted: January 11, 2021

Record last verified: 2021-11

Locations

US (1)