- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03192137
Study to Evaluate ISV-305 Compared to Vehicle for Treatment of Inflammation and Pain Associated With Cataract Surgery (ISV-305)
November 18, 2021 updated by: Sun Pharmaceutical Industries Limited
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
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of ISV-305 (dexamethasone in DuraSite® 2) compared with Vehicle in the treatment of inflammation and pain associated with cataract surgery.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy of topical administration of ISV-305 (0.1% dexamethasone in DuraSite® 2) compared with Vehicle when dosed twice daily for 1 day prior to surgery, the day of surgery and 14 days post cataract surgery.
Study Type
Interventional
Enrollment (Actual)
260
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Tennessee
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Memphis, Tennessee, United States, 38120
- Clinical Research Center
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
17 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
- 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)
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ISV-305
0.1% dexamethasone in DuraSite® 2
|
Dexamethasone in DuraSite® 2 twice daily for 16 days
|
Placebo Comparator: Vehicle
DuraSite® 2 Vehicle
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Vehicle twice daily for 16 days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Participants With Anterior Chamber Cell (ACC) Grade 0 in Study Eye at Day 15 (Last Observation Carried Forward) in the Modified Intent to Treat (mITT) Population
Time Frame: Day 15
|
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).
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Day 15
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of Participants Who Achieved a Pain Score of 0 on the Visual Analog Scale (VAS) for Each Post-surgical Assessment
Time Frame: Day 1 to Day 29
|
Eye pain/discomfort in the study eye was evaluated at every visit except Visit 2 (Surgery; Day 0) using a VAS, scoring from 0 to 100 using a mark on a 100 mm line (0 = absent; 100 = maximum).
Participants were asked to rate the feeling of the symptom in the study eye from absent to extreme by moving a slide on the side of the scale to align with images of descriptive faces.
|
Day 1 to Day 29
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 30, 2018
Primary Completion (Actual)
April 17, 2019
Study Completion (Actual)
April 17, 2019
Study Registration Dates
First Submitted
June 15, 2017
First Submitted That Met QC Criteria
June 15, 2017
First Posted (Actual)
June 19, 2017
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- C-13-305-002
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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