Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects
Study Details
Study Description
Brief Summary
The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ISV-303
|
Drug: ISV-303
0.075% bromfenac in DuraSite dosed BID
|
| Placebo Comparator: Durasite Vehicle
|
Other: DuraSite Vehicle
DuraSite vehicle dosed BID
|
Outcome Measures
Primary Outcome Measures
- Ocular Inflammation [15 days]
Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells, and no rescue medications.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
-
If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. 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
-
Signature of the subject on the Informed Consent Form
-
Willing to avoid disallowed medications for the duration of the study
-
Willing and able to follow all instructions and attend all study visits
-
Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs )
-
Additional inclusion criteria also apply
Exclusion Criteria:
-
Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications
-
Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
-
Currently suffer from alcohol and/or drug abuse
-
Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
-
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 inclusion criteria also apply
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Sun Pharmaceutical Industries Limited
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- C-12-303-004
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | ISV-303 | Vehicle |
|---|---|---|
| Arm/Group Description | 0.075% bromfenac in DuraSite dosed BID | DuraSite vehicle dosed BID |
| Period Title: Overall Study | ||
| STARTED | 174 | 94 |
| Safety Population | 170 | 85 |
| mITT Population | 168 | 85 |
| COMPLETED | 137 | 48 |
| NOT COMPLETED | 37 | 46 |
Baseline Characteristics
| Arm/Group Title | ISV-303 | Vehicle | Total |
|---|---|---|---|
| Arm/Group Description | 0.075% bromfenac in DuraSite dosed BID | DuraSite vehicle dosed BID | Total of all reporting groups |
| Overall Participants | 168 | 85 | 253 |
| Age (years) [Mean (Standard Deviation) ] | |||
| Mean (Standard Deviation) [years] |
69.6
(8.90)
|
72.0
(9.07)
|
70.4
(9.01)
|
| Age, Customized (participants) [Number] | |||
| < 65 years |
44
26.2%
|
16
18.8%
|
60
23.7%
|
| ≥ 65 years |
124
73.8%
|
69
81.2%
|
193
76.3%
|
| Sex: Female, Male (Count of Participants) | |||
| Female |
105
62.5%
|
48
56.5%
|
153
60.5%
|
| Male |
63
37.5%
|
37
43.5%
|
100
39.5%
|
Outcome Measures
| Title | Ocular Inflammation |
|---|---|
| Description | Anterior chamber cell grade 0 at Day 15 measured on a 0 to 4 scale where "0" is 0 cells; "1" is 1-10 cells; "2" is 11-20 cells; "3" is 21-50 cells; "4" is > 50 cells, and no rescue medications. |
| Time Frame | 15 days |
Outcome Measure Data
| Analysis Population Description |
|---|
| Modified Intent-to-Treat (ITT) Population using Last Observation Carried Forward (LOCF) method. |
| Arm/Group Title | ISV-303 | Vehicle |
|---|---|---|
| Arm/Group Description | 0.075% bromfenac in DuraSite dosed BID | DuraSite vehicle dosed BID |
| Measure Participants | 168 | 85 |
| Number [participants] |
64
38.1%
|
19
22.4%
|
Adverse Events
| Time Frame | 29 days | |||
|---|---|---|---|---|
| Adverse Event Reporting Description | ||||
| Arm/Group Title | ISV-303 | Vehicle | ||
| Arm/Group Description | 0.075% bromfenac in DuraSite dosed BID | DuraSite vehicle dosed BID | ||
All Cause Mortality |
||||
| ISV-303 | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | ||
Serious Adverse Events |
||||
| ISV-303 | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/170 (0.6%) | 1/85 (1.2%) | ||
| Gastrointestinal disorders | ||||
| Colitis | 0/170 (0%) | 1/85 (1.2%) | ||
| General disorders | ||||
| Chest pain | 1/170 (0.6%) | 0/85 (0%) | ||
Other (Not Including Serious) Adverse Events |
||||
| ISV-303 | Vehicle | |||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 17/170 (10%) | 5/85 (5.9%) | ||
| Eye disorders | ||||
| Ocular hypertension | 17/170 (10%) | 5/85 (5.9%) | ||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
Results Point of Contact
| Name/Title | Senior Manager, Clinical Sciences |
|---|---|
| Organization | InSite Vision |
| Phone | |
| manjiri.desai@sparcmail.com |
- C-12-303-004