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Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects (ISV-305)

Primary Purpose

Active, Symptomatic Blepharitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
ISV-305
Vehicle
Sponsored by
Sun Pharmaceutical Industries Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Active, Symptomatic Blepharitis

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Are at least 1 years of age and have a clinical diagnosis of active, symptomatic blepharitis
  • 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 (this applies to parent or caregiver for subjects too young to self-apply investigational product)
  • 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 had eyelid surgery in the study eye within twelve (12) months prior to Visit 1 or plan to have eyelid surgery during the study
  • Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than blepharitis in the study eye
  • Have used topical medications on the eyelids or topical ophthalmic corticosteroid medications or systemic use of a corticosteroid mediation within 14 days prior to dosing and/or plan to use them throughout the duration of the study
  • Be currently pregnant, nursing, or planning a pregnancy; or be a woman who has a positive urine pregnancy test
  • Have prior (within 30 days prior to dosing) 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
  • Additional exclusion criteria also apply

Sites / Locations

  • Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ISV-305

Vehicle

Arm Description

0.1% dexamethasone in DuraSite® 2

DuraSite® 2 vehicle

Outcomes

Primary Outcome Measures

Number of Participants in the ITT Population With a Reduction in the Day 1 (Baseline) Total Clinical Signs and Symptom Score by at Least 2 Units at Day 15 With No Worsening of Any Sign or Symptom
The clinical signs of blepharitis (eyelid swelling, eyelid redness, eyelid debris) were evaluated at every visit and scored by the investigator using a 0 to 3 grading scale (in general 0 = none, 1 = mild, 2 = moderate, and 3 = severe). The symptom of eyelid irritation was also evaluated at every visit and graded by the participant using a 0 to 3 grading scale (0 = almost none of the time - ≤ 25% of the time, 1 = occasionally - 26-50% of the time, 2 = frequently - 51-75% of the time, 3 = almost all of the time - ≥ 76% of the time). For each visit, the total clinical signs and symptom score was obtained by adding each of the individual scores for each domain (eyelid swelling, eyelid redness, eyelid debris, and eyelid irritation). Participants with a decrease in total clinical signs and symptom score at Day 15 by at least 2 units from Day 1 (baseline) with no increase in any sign and symptom were defined as Responders, and those not meeting these criteria were defined as Non-responders.

Secondary Outcome Measures

Number of Participants With Complete Resolution of Eyelid Irritation (Last Observation Carried Forward [LOCF]) on Day 15 in ITT Population
Complete resolution of eyelid irritation, which was defined as eyelid irritation with grading of 0, at Day 15 was analyzed. The symptoms of eyelid irritation were graded by the participant using a 0 to 3 grading scale, where 0 = almost none of the time - ≤ 25% of the time, 1 = occasionally - 26-50% of the time, 2 = frequently - 51-75% of the time, 3 = almost all of the time - ≥ 76% of the time.

Full Information

First Posted
February 28, 2012
Last Updated
November 18, 2021
Sponsor
Sun Pharmaceutical Industries Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01543490
Brief Title
Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects
Acronym
ISV-305
Official Title
A Phase 3, Multicenter, Randomized, Double-Masked, Parallel-Group, Comparative Study to Evaluate the Clinical Efficacy and Safety of ISV-305 (0.1% Dexamethasone) Compared to Vehicle in the Treatment of Subjects With Blepharitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
March 30, 2018 (Actual)
Primary Completion Date
February 4, 2020 (Actual)
Study Completion Date
February 4, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Pharmaceutical Industries Limited

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the clinical efficacy and safety of ISV-305 (Dexamethasone in DuraSite® 2) compared to Vehicle in the treatment of subjects with active, symptomatic Blepharitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Active, Symptomatic Blepharitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
558 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ISV-305
Arm Type
Experimental
Arm Description
0.1% dexamethasone in DuraSite® 2
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
DuraSite® 2 vehicle
Intervention Type
Drug
Intervention Name(s)
ISV-305
Intervention Description
Dexamethasone in DuraSite® 2 twice daily for 2 weeks
Intervention Type
Other
Intervention Name(s)
Vehicle
Intervention Description
Vehicle twice daily for 2 weeks
Primary Outcome Measure Information:
Title
Number of Participants in the ITT Population With a Reduction in the Day 1 (Baseline) Total Clinical Signs and Symptom Score by at Least 2 Units at Day 15 With No Worsening of Any Sign or Symptom
Description
The clinical signs of blepharitis (eyelid swelling, eyelid redness, eyelid debris) were evaluated at every visit and scored by the investigator using a 0 to 3 grading scale (in general 0 = none, 1 = mild, 2 = moderate, and 3 = severe). The symptom of eyelid irritation was also evaluated at every visit and graded by the participant using a 0 to 3 grading scale (0 = almost none of the time - ≤ 25% of the time, 1 = occasionally - 26-50% of the time, 2 = frequently - 51-75% of the time, 3 = almost all of the time - ≥ 76% of the time). For each visit, the total clinical signs and symptom score was obtained by adding each of the individual scores for each domain (eyelid swelling, eyelid redness, eyelid debris, and eyelid irritation). Participants with a decrease in total clinical signs and symptom score at Day 15 by at least 2 units from Day 1 (baseline) with no increase in any sign and symptom were defined as Responders, and those not meeting these criteria were defined as Non-responders.
Time Frame
Day 15
Secondary Outcome Measure Information:
Title
Number of Participants With Complete Resolution of Eyelid Irritation (Last Observation Carried Forward [LOCF]) on Day 15 in ITT Population
Description
Complete resolution of eyelid irritation, which was defined as eyelid irritation with grading of 0, at Day 15 was analyzed. The symptoms of eyelid irritation were graded by the participant using a 0 to 3 grading scale, where 0 = almost none of the time - ≤ 25% of the time, 1 = occasionally - 26-50% of the time, 2 = frequently - 51-75% of the time, 3 = almost all of the time - ≥ 76% of the time.
Time Frame
Day 15

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Are at least 1 years of age and have a clinical diagnosis of active, symptomatic blepharitis 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 (this applies to parent or caregiver for subjects too young to self-apply investigational product) 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 had eyelid surgery in the study eye within twelve (12) months prior to Visit 1 or plan to have eyelid surgery during the study Have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than blepharitis in the study eye Have used topical medications on the eyelids or topical ophthalmic corticosteroid medications or systemic use of a corticosteroid mediation within 14 days prior to dosing and/or plan to use them throughout the duration of the study Be currently pregnant, nursing, or planning a pregnancy; or be a woman who has a positive urine pregnancy test Have prior (within 30 days prior to dosing) 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 Additional exclusion criteria also apply
Facility Information:
Facility Name
Clinical Research Center
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States

12. IPD Sharing Statement

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Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects

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