A Phase 3 interventional study of ISV-305 and Vehicle in Active, Symptomatic Blepharitis, sponsored by Sun Pharmaceutical Industries Limited. Completed at 1 site in United States. Open to participants aged 1 Year and older. Per ClinicalTrials.gov, last updated 2021-11-19.
Sponsored by Sun Pharmaceutical Industries Limited · Phase 3, Interventional, and Treatment
Among 2,858 studies in Motor Activity with a site in United States — 423 open to participants now, 564 under way, 9 of them phase 3. Motor Activity · United States.
Among the 2,858 studies in Motor Activity with a site in United States, this one is the 140th largest by enrollment of the 2,605 interventional ones that give a count, is one of 170 that started in 2018, is one of 58 in phase 3, and was the 630th registered.
9,798 studies on the registry are indexed under Motor Activity; 1,910 are open to participants now.
Browse Motor Activity studies →423 of the 2,858 studies in Motor Activity with a site in United States are open now. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 18–80 · Men only
University of Pennsylvania · Sites in United States
Ages 18+
San Diego State University · Sites in United States
Ages 18+ · Women only
Beth Israel Deaconess Medical Center · Sites in United States
Ages 18–40 · Healthy volunteers
University of Arizona · Sites in United States
Ages up to 65
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 1,201 Motor Activity studies recruiting now, 517 (43%) set no upper age limit and 535 (45%) stop at 75 or younger; 180 take children under 18; 420 take healthy volunteers.
This study: 1 Year and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
2,858 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 139 · Phase 2 180 · Phase 3 83 · Phase 4 33
First in 1977; this study’s year is marked. 170 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 558 is above the median of 60 across 8,388 interventional studies indexed under Motor Activity.
Median enrollment 55 across the 2,605 interventional studies, 67 across the 240 observational. Of the 2,100 that completed or were terminated, 539 (26%) have results posted.
This tab as a report to print or save as PDF → With an account.
82 of 2,858 have an industry lead sponsor. The 10 most frequent:
Sun Pharmaceutical Industries Limited is the lead sponsor of 60 studies on the registry; 5 are open to participants now.
Of its 24 completed or terminated interventional studies of FDA-regulated products, 22 (92%) have results posted.
Sun Pharmaceutical Industries Limited has 1 study filed under Motor Activity — fewer than ten, so there is no comparison to draw.
210 of the studies in Motor Activity with a site in United States that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07298915Phase 3University of VirginiaThe Effect of Exercise and Tirzepatide on Weight and Health Outcomes (EXER-MED) | 2026-12 |
| NCT06159335Phase 3University of Wisconsin, Madison18F-FLUC PET/MR in Patients With Brain Mets | 2027-06 |
| NCT05422534Phase 3Vanderbilt University Medical CenterCoQ10 and Exercise for Mitochondrial Dysfunction in Advance Kidney Disease | 2027-06-20 |
| NCT07125027National University of Natural MedicineA Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE | 2026-11 |
| NCT06290713University of FloridaVasodilator and Exercise Study for DMD (VASO-REx) | 2026-11 |
Among the 2,858 studies in Motor Activity with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
0.1% dexamethasone in DuraSite® 2
Drug: ISV-305
DuraSite® 2 vehicle
Other: Vehicle
Dexamethasone in DuraSite® 2 twice daily for 2 weeks
Vehicle twice daily for 2 weeks
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.
Time frame: Day 15
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.
Time frame: Day 15
| Milestone | ISV-305 | Vehicle |
|---|---|---|
| Started | 368 | 190 |
| Completed | 352 | 185 |
| Not completed | 16 | 5 |
| Withdrew: Adverse event | 4 | 0 |
| Withdrew: Physician decision | 1 | 0 |
| Withdrew: Lack of efficacy | 3 | 3 |
| Withdrew: Lost to follow-up | 5 | 0 |
| Withdrew: Withdrawal by subject | 2 | 0 |
| Withdrew: Other-various administrative reasons | 1 | 2 |
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.
| Participants | ISV-305 | Vehicle |
|---|---|---|
| Responders | 276 | 129 |
| Non-responders | 77 | 56 |
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.
| Participants | ISV-305 | Vehicle |
|---|---|---|
| With Complete Resolution | 127 | 52 |
| Without Complete Resolution | 241 | 138 |
Collected over 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 41 days.. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ISV-305 | 0/367 (0%) | 4/367 (1.1%) | 7/367 (1.9%) |
| Vehicle | 0/188 (0%) | 0/188 (0%) | 5/188 (2.7%) |
| Event | ISV-305 | Vehicle |
|---|---|---|
| SyncopeNervous system disorders | 1/367 | 0/188 |
| Transient global amnesiaNervous system disorders | 1/367 | 0/188 |
| Retinal detachmentEye disorders | 1/367 | 0/188 |
| CholecystitisHepatobiliary disorders | 1/367 | 0/188 |
| CholelithiasisHepatobiliary disorders | 1/367 | 0/188 |
| Event | ISV-305 | Vehicle |
|---|---|---|
| Conjunctival hyperaemiaEye disorders | 7/367 | 5/188 |
Demographics were summarized for the Intent-to-treat (ITT) Population, which included all randomized participants regardless of whether post-baseline measures were collected or study treatment was received.
| Age, Customized(Participants) | ISV-305 | Vehicle | Total |
|---|---|---|---|
| < 17 years | 0 | 0 | 0 |
| 17 to < 65 years | 146 | 66 | 212 |
| ≥ 65 years | 222 | 124 | 346 |
| Sex: Female, Male(Participants) | ISV-305 | Vehicle | Total |
|---|---|---|---|
| Female | 209 | 107 | 316 |
| Male | 159 | 83 | 242 |
| Race/Ethnicity, Customized(Participants) | ISV-305 | Vehicle | Total |
|---|---|---|---|
| African American or Black | 20 | 2 | 22 |
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 6 | 3 | 9 |
| White | 334 | 184 | 518 |
| Native Hawaiian or Other Pacific Islander | 2 | 0 | 2 |
| Mixed | 1 | 0 | 1 |
| Other | 5 | 1 | 6 |
| Region of Enrollment(Participants) | ISV-305 | Vehicle | Total |
|---|---|---|---|
| United States | 368 | 190 | 558 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Mar 2018 to primary completion in Feb 2020, 22 months.
Results were first posted in Mar 2021, 1 year 1 month after primary completion.
Of 33 phase 3 interventional studies under Motor Activity, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 47. This study's 22 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexamethasone
Sun Pharmaceutical Industries Limited →