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NCT01543490 · ClinicalTrials.gov registry record · Phase 3
Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects
A Phase 3 study, sponsored by Sun Pharmaceutical Industries Limited.
- Completed
- Registry status
- Phase 3
- Development phase
- 558
- Enrollment target
NCT01543490: Completed Phase 3 study, sponsored by Sun Pharmaceutical Industries Limited.
NCT01543490 is a Phase 3 study that has completed, run by Sun Pharmaceutical Industries Limited. The registered enrollment target is 558 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01543490, a Phase 3 study, has completed, sponsored by Sun Pharmaceutical Industries Limited.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 558 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 a
Interventions
- OTHER Vehicle
- DRUG ISV-305
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 558 participants |
| Start Date | 2018-03-30 |
| Est. Completion | 2020-02-04 |
| Phase | Phase 3 |
What the finished NCT01543490 record still lists
NCT01543490 is an interventional study that assigns participants to a tested intervention. The registered 558 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (28% lower).
The record links to 0 conditions, and to 2 interventions - of which Vehicle is the first listed.
NCT01543490 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01543490 about?
NCT01543490 is a clinical study titled "Comparative Study to Evaluate ISV-305 Compared to Vehicle in Blepharitis Subjects". 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.
What is the current status of trial NCT01543490?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 558 participants. The study started on 2018-03-30. Estimated completion is 2020-02-04.
What interventions are being tested in trial NCT01543490?
The interventions under investigation include: Vehicle (OTHER), ISV-305 (DRUG).
Who is sponsoring clinical trial NCT01543490?
This trial is sponsored by Sun Pharmaceutical Industries Limited, which has 38 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01543490's enrollment target sits among peer trials
558 673rd of 2000 higher than 1,327 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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