Trial · NCT04246801
Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1)
NCT04246801, Phase 3, Completed, Salvat; results first posted 2022-12-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1). Trials, record NCT04246801. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04246801
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Clobetasol Propionate Ophthalmic Nanoemulsion 0.05% for the Treatment of Inflammation and Pain Associated With Cataract Surgery (CLOSE-1)
- NCT number
- NCT04246801
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 250 participants, actual
- Lead sponsor
- Salvat
- Conditions
- Cataract
- Interventions
- Clobetasol propionate, Vehicle
- First posted
- 2020-01-29
- Last updated
- 2022-12-22
- Results first posted
- 2022-12-22
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Anterior Chamber Cell Grade | Day 8 | Percentage of participants with anterior chamber cell grade of "0" (absence of cells) |
| Secondary | Pain Visual Analogue Scale (VAS) Score | Day 8 | Percentage of participants with VAS pain score of "0" (no eye pain). Pain was scored by ticking on a continuous scale comprised of a 10 cm horizontal line anchored by two verbal descriptions: "no eye pain" (score of 0) and "worst imaginable eye pain" (score of 10). |
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 | Anterior Chamber Cell Grade | Day 8 | FAS Population with anterior chamber cell grade assessment at Day 8 | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Pain Visual Analogue Scale (VAS) Score | Day 8 | FAS Population with pain VAS assessment at Day 8 | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Anterior Chamber Cell Grade | Clobetasol Propionate | 67 | Participants | ||
| Anterior Chamber Cell Grade | Placebo | 18 | Participants | ||
| Pain Visual Analogue Scale (VAS) Score | Clobetasol Propionate | 83 | Participants | ||
| Pain Visual Analogue Scale (VAS) Score | Placebo | 19 | 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 | Clobetasol Propionate | 140 | |
| Overall Study | STARTED | Placebo | 71 | |
| Overall Study | COMPLETED | Clobetasol Propionate | 135 | |
| Overall Study | COMPLETED | Placebo | 65 | |
| Overall Study | NOT COMPLETED | Clobetasol Propionate | 5 | |
| Overall Study | NOT COMPLETED | Placebo | 6 |
Source ClinicalTrials.gov
Adverse events8
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 | Eye Pain | Eye disorders | Clobetasol Propionate | 0 | 140 | 0 |
| other | Eye Pain | Eye disorders | Placebo | 3 | 71 | 3 |
| other | Lacrimation increased | Eye disorders | Clobetasol Propionate | 1 | 140 | 1 |
| other | Lacrimation increased | Eye disorders | Placebo | 2 | 71 | 2 |
| other | Photophobia | Endocrine disorders | Clobetasol Propionate | 0 | 140 | 0 |
| other | Photophobia | Endocrine disorders | Placebo | 3 | 71 | 3 |
| serious | Cystoid Macular oedema | Eye disorders | Clobetasol Propionate | 1 | 140 | 1 |
| serious | Cystoid Macular oedema | Eye disorders | Placebo | 0 | 71 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Clobetasol Propionate | 0 | 140 |
| Total, all-cause mortality | Placebo | 0 | 71 |
| Total, other adverse events | Clobetasol Propionate | 1 | 140 |
| Total, other adverse events | Placebo | 5 | 71 |
| Total, serious adverse events | Clobetasol Propionate | 1 | 140 |
| Total, serious adverse events | Placebo | 0 | 71 |
Source ClinicalTrials.gov
Papers12
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Clobetasol Propionate vs Placebo: Anterior Chamber Cell Grade | Trial comparisons |
| Clobetasol Propionate vs Placebo: Pain Visual Analogue Scale (VAS) Score | Trial comparisons |
| Clobetasol Propionate vs Placebo: deaths from any cause | Trial comparisons |
| Clobetasol Propionate vs Placebo: 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/NCT04246801
GET https://conductscience.org/api/trials/v1/NCT04246801/registered