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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ISV-305 | Experimental | 0.1% dexamethasone in DuraSite® 2 |
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| Vehicle | Placebo Comparator | DuraSite® 2 vehicle |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ISV-305 | Drug | Dexamethasone in DuraSite® 2 twice daily for 16 days |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Research Center | Austin | Texas | 78731 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ISV-305 | ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days. |
| FG001 | Vehicle |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 31, 2017 | Nov 4, 2020 |
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| Vehicle |
| Other |
Vehicle twice daily for 16 days |
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| Day 1 to Day 29 |
Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days. |
| COMPLETED |
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| NOT COMPLETED |
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Demographics were summarized for the Safety Population, which included all the randomized participants who received at least one dose of study treatment.
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| ID | Title | Description |
|---|---|---|
| BG000 | ISV-305 | ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days. |
| BG001 | Vehicle | Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | 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). | mITT Population - included randomized participants who underwent cataract surgery, received at least one dose of ISV-305 or vehicle, and had at least one post-surgery efficacy assessment (ACC or VAS). Participants who received rescue medications were included in the mITT Population, but were treated as failures. | Posted | Count of Participants | Participants | No | Day 15 |
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| Secondary | 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 | 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. | mITT Population - included randomized participants who underwent cataract surgery, received at least one dose of ISV-305 or vehicle, and had at least one post-surgery efficacy assessment (ACC or VAS). Participants who received rescue medications were included in the mITT Population, but were treated as failures. | Posted | Count of Participants | Participants | No | Day 1 to Day 29 |
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Adverse events (AEs) were reported from the date of signing the consent form to the date of completion of the participant's final visit (Day 29). Ongoing AEs were followed beyond the final study visit at the discretion of the investigator, observed up to 45 days.
Treatment-emergent adverse events were summarized for the Safety Population, which included all randomized participants who received at least one dose of study treatment (i.e., 152 and 79 participants in the ISV-305 and Vehicle arms, respectively).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ISV-305 | ISV-305 was administered as a topical ophthalmic formulation of 0.1% dexamethasone in DuraSite® 2 vehicle (InSite Vision's drug delivery system) twice daily (one drop in the morning and one drop in the evening) for 16 days. | 0 | 152 | 1 | 152 | 47 | 152 |
| EG001 | Vehicle | Vehicle (DuraSite® 2 vehicle) was administered as a matching topical ophthalmic formulation without dexamethasone twice daily (one drop in the morning and one drop in the evening) for 16 days. | 0 | 79 | 0 | 79 | 30 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Small intestinal obstruction | Gastrointestinal disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anterior chamber cell | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Conjunctival hyperaemia | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Visual acuity reduced | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Corneal oedema | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Anterior chamber flare | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Conjunctival oedema | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Eye pain | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Conjunctival haemorrhage | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Ciliary hyperaemia | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Foreign body sensation in eyes | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Punctate keratitis | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Intraocular pressure increased | Investigations | MedDRA Version 20.1 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Photophobia | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Posterior capsule opacification | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Corneal disorder | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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| Corneal pigmentation | Eye disorders | MedDRA Version 20.1 | Non-systematic Assessment |
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The investigator agrees to submit the manuscript of any journal article, abstract or other presentation arising from an InSite Vision-sponsored clinical investigation to InSite Vision for editorial review prior to submission for publication or presentation. At the sponsor's request, if proprietary information is to be disclosed, proposed publications or presentations will be delayed until appropriate patent applications and/or legal documents of a similar nature have been filed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Head, Clinical development | Sun Pharma Global FZE | 91 2266455645 | Clinical.Trials@sparcmail.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 12, 2020 | Dec 3, 2020 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Male |
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| American Indian or Alaska Native |
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| Asian |
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| White |
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| Native Hawaiian or Other Pacific Islander |
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| Mixed |
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| Other |
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| 1 |
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| 2 |
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| 3 |
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| 4 |
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