Trial · NCT01543490
Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects
NCT01543490, Phase 3, Completed, Sun Pharmaceutical Industries Limited; results first posted 2021-03-23
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects. Trials, record NCT01543490. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01543490
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects
- NCT number
- NCT01543490
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 558 participants, actual
- Lead sponsor
- Sun Pharmaceutical Industries Limited
- Conditions
- Active, Symptomatic Blepharitis
- Interventions
- ISV-305, Vehicle
- First posted
- 2012-03-05
- Last updated
- 2021-11-19
- Results first posted
- 2021-03-23
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Day 15 | 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 | Number of Participants With Complete Resolution of Eyelid Irritation (Last Observation Carried Forward [LOCF]) on Day 15 in ITT Population | Day 15 | 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. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Day 15 | ITT Population, which included all randomized participants regardless of whether post-baseline measures were collected or study treatment was received. The participants only with valid measurement at Day 15 were used as the denominator for percentages (353 out of 368 participants for ISV-305 and 185 out of 190 participants in Vehicle). | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Complete Resolution of Eyelid Irritation (Last Observation Carried Forward [LOCF]) on Day 15 in ITT Population | Day 15 | ITT Population, which included all randomized participants regardless of whether post-baseline measures were collected or study treatment was received. Participants with a valid post-baseline measurement on or before at Day 15 were used as the denominator for percentages (368 for ISV-305 and 190 for Vehicle). | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | ISV-305 | Responders | 276 | Participants | |
| 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 | Vehicle | Responders | 129 | Participants | |
| 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 | ISV-305 | Non-responders | 77 | Participants | |
| 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 | Vehicle | Non-responders | 56 | Participants | |
| Number of Participants With Complete Resolution of Eyelid Irritation (Last Observation Carried Forward [LOCF]) on Day 15 in ITT Population | ISV-305 | With Complete Resolution | 127 | Participants | |
| Number of Participants With Complete Resolution of Eyelid Irritation (Last Observation Carried Forward [LOCF]) on Day 15 in ITT Population | Vehicle | With Complete Resolution | 52 | Participants | |
| Number of Participants With Complete Resolution of Eyelid Irritation (Last Observation Carried Forward [LOCF]) on Day 15 in ITT Population | ISV-305 | Without Complete Resolution | 241 | Participants | |
| Number of Participants With Complete Resolution of Eyelid Irritation (Last Observation Carried Forward [LOCF]) on Day 15 in ITT Population | Vehicle | Without Complete Resolution | 138 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | ISV-305 | 368 | |
| Overall Study | STARTED | Vehicle | 190 | |
| Overall Study | COMPLETED | ISV-305 | 352 | |
| Overall Study | COMPLETED | Vehicle | 185 | |
| Overall Study | NOT COMPLETED | ISV-305 | 16 | |
| Overall Study | NOT COMPLETED | Vehicle | 5 |
Source ClinicalTrials.gov
Adverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Conjunctival hyperaemia | Eye disorders | ISV-305 | 7 | 367 | |
| other | Conjunctival hyperaemia | Eye disorders | Vehicle | 5 | 188 | |
| serious | Syncope | Nervous system disorders | ISV-305 | 1 | 367 | |
| serious | Syncope | Nervous system disorders | Vehicle | 0 | 188 | |
| serious | Transient global amnesia | Nervous system disorders | ISV-305 | 1 | 367 | |
| serious | Transient global amnesia | Nervous system disorders | Vehicle | 0 | 188 | |
| serious | Retinal detachment | Eye disorders | ISV-305 | 1 | 367 | |
| serious | Retinal detachment | Eye disorders | Vehicle | 0 | 188 | |
| serious | Cholecystitis | Hepatobiliary disorders | ISV-305 | 1 | 367 | |
| serious | Cholecystitis | Hepatobiliary disorders | Vehicle | 0 | 188 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | ISV-305 | 0 | 367 |
| Total, all-cause mortality | Vehicle | 0 | 188 |
| Total, other adverse events | ISV-305 | 7 | 367 |
| Total, other adverse events | Vehicle | 5 | 188 |
| Total, serious adverse events | ISV-305 | 4 | 367 |
| Total, serious adverse events | Vehicle | 0 | 188 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| ISV-305 vs Vehicle: deaths from any cause | Trial comparisons |
| ISV-305 vs Vehicle: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01543490
GET https://conductscience.org/api/trials/v1/NCT01543490/registered