Inflammation and Pain Associated With Cataract SurgeryPhase 3ISV-305NCT03192137

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

A Phase 3 study testing ISV-305 in people with Inflammation and Pain Associated With Cataract Surgery, run by Sun Pharmaceutical Industries Limited at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 17 years and older
Conditions the study is for: Inflammation and Pain Associated With Cataract Surgery
What is being tested?: ISV-305
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 260 participants
Where: 1 siteUnited States
Study dates: 30 Jan 2018to 17 Apr 2019
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 17 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 12Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Clinical Research Center
Memphis, Tennessee, 38120

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Inflammation and Pain Associated With Cataract Surgery
Being tested: ISV-305, Vehicle
Medical subject headings: Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ISV-305Drug
Dexamethasone in DuraSite® 2 twice daily for 16 days
VehicleOther
Vehicle twice daily for 16 days

Study groups in NCT03192137
Study group	Role	What they receive
ISV-305	Experimental	0.1% dexamethasone in DuraSite® 2 Receives: Drug: ISV-305
Vehicle	Placebo comparator	DuraSite® 2 Vehicle Receives: Other: Vehicle

What is being measured

The primary outcome is the main question the study is designed to answer.

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
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).
Measured: Day 15

Secondary outcomes (1)

Proportion of Participants Who Achieved a Pain Score of 0 on the Visual Analog Scale (VAS) for Each Post-surgical Assessment
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.
Measured: Day 1 to Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Jan 201817 Apr 2019

First posted19 Jun 2017
Study start30 Jan 2018
Primary completion17 Apr 2019
Study completion17 Apr 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Inflammation and Pain Associated With Cataract SurgeryStudies of the same condition, open and under way.
More trials run by Sun Pharmaceutical Industries LimitedThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 260 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03192137
Sponsor's protocol ID: C-13-305-002
Acronym: ISV-305
Status last verified: Nov 2021
First submitted: 15 Jun 2017
Last updated: 19 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Study at a glance

From the registry record, last updated by the sponsor on 19 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT03192137
Acronym / sponsor ID: ISV-305 / C-13-305-002
Conditions: Inflammation and Pain Associated With Cataract Surgery
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 260 participants (actual)
Lead sponsor: Sun Pharmaceutical Industries LimitedIndustry (pharma, biotech, devices)
Study start: 30 Jan 2018 (actual)
Primary completion: 17 Apr 2019 (actual)
Study completion: 17 Apr 2019 (actual)
First posted: 19 Jun 2017 (actual)
Results: Posted 29 Jun 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
ISV-305	Experimental	Drug: ISV-3050.1% dexamethasone in DuraSite® 2
Vehicle	Placebo comparator	Other: VehicleDuraSite® 2 Vehicle

Who may qualify

Ages: 17 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (8 listed)

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

Key exclusion criteria (12 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ISV-305Dexamethasone in DuraSite® 2 twice daily for 16 days	Drug	ISV-305
VehicleVehicle twice daily for 16 days	Other	Vehicle

Primary outcome

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).

1 secondary outcome

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

Results and safety

Results posted to the registry on 29 Jun 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
ISV-305	173	123
Vehicle	87	29

Primary outcome: 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. Number. Unit: participants

Measure	ISV-305 n = 144	Vehicle n = 72
0 (did not receive rescue therapy)	69	16
0 (received rescue therapy)	0	0
1	64	30
2	5	10
3	6	12
4	0	4

ISV-305 vs Vehicle: p = 0.0005, Chi-squared, Corrected

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 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.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ISV-305	3 of 158 (1.9%)	31 of 158 (19.6%)	0 of 158
Vehicle	0 of 80 (0%)	21 of 80 (26.3%)	0 of 80

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ISV-305 in people with Inflammation and Pain Associated With Cataract Surgery, run by Sun Pharmaceutical Industries Limited at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03192137.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2021.