Trial · NCT02256969
Intraductal Meibomian Gland Probing Trial
NCT02256969, Phase 4, Completed, Joseph B. Ciolino, MD; results first posted 2017-05-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Intraductal Meibomian Gland Probing Trial. Trials, record NCT02256969. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02256969
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Intraductal Meibomian Gland Probing Trial
- NCT number
- NCT02256969
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 45 participants, actual
- Lead sponsor
- Joseph B. Ciolino, MD
- Conditions
- Meibomian Gland Dysfunction
- Interventions
- Blephamide, GenTeal PM Night-Time, Meibomian Gland Probing, Sham Meibomian Gland Probing
- First posted
- 2014-10-06
- Last updated
- 2017-06-19
- Results first posted
- 2017-05-22
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Ocular Surface Disease Index (OSDI) | 4 week Time Point | A 12-question survey used to measure the symptoms of dry eye disease. Each of the 12 individual questions rate one symptom on a 0-4 scale, with 4 meaning that the symptom is present all of the time and 0 meaning the symptom is present none of the time. The overall ODSI score is calculated by adding all of the values from the 12 questions, multiplying that value by 25, and dividing the resulting value by the number of questions answered. This results in an overall scale that ranges from 0-100, with 100 being severe dry eye symptoms and 0 being no dry eye symptoms. |
| Primary | Symptom Assessment in Dry Eye (SANDE) | 4 week Time Point | A two-item survey used to assess the frequency and severity of dry eye disease. The SANDE score is calculated by taking the square root of the product of the frequency of symptoms score and the severity of symptoms score. The SANDE scale ranges from 0 to 100 with 100 being the maximal amount of dry eye symptoms and 0 being the minimal amount of dry eye symptoms. |
| Primary | Corneal Fluorescein Staining (CFS) | 4 week Time Point | Is used to assess the level of corneal epitheliopathy that is related to dry eye disease. The CFS scale ranges from 0 to 15 scale, with 0 representing the minimum level of corneal epitheliopathy and 15 representing the maximum level of epitheliopathy. |
| Primary | Tear Break Up Time (TBUT) | 4 week Time Point | TBUT measures the amount of time, in seconds, a dry spot appears in the tear film after each blink. Values less than 10 seconds are considered abnormal. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Ocular Surface Disease Index (OSDI) | 4 week Time Point | units on a scale | MEAN | |
| PRIMARY | Symptom Assessment in Dry Eye (SANDE) | 4 week Time Point | units on a scale | MEAN | |
| PRIMARY | Corneal Fluorescein Staining (CFS) | 4 week Time Point | units on a scale | MEAN | |
| PRIMARY | Tear Break Up Time (TBUT) | 4 week Time Point | Seconds | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Ocular Surface Disease Index (OSDI) | Meibomian Gland Probing Plus Lubricant | 38.7 | Standard Deviation 20.3 | units on a scale | |
| Ocular Surface Disease Index (OSDI) | Sham Meibomian Gland Probing Plus Lubricant | 36.9 | Standard Deviation 28.2 | units on a scale | |
| Ocular Surface Disease Index (OSDI) | Meibomian Gland Probing Plus Blephamide | 37.3 | Standard Deviation 21.0 | units on a scale | |
| Symptom Assessment in Dry Eye (SANDE) | Meibomian Gland Probing Plus Lubricant | 49.1 | Standard Deviation 22.5 | units on a scale | |
| Symptom Assessment in Dry Eye (SANDE) | Sham Meibomian Gland Probing Plus Lubricant | 50.2 | Standard Deviation 27.6 | units on a scale | |
| Symptom Assessment in Dry Eye (SANDE) | Meibomian Gland Probing Plus Blephamide | 47.6 | Standard Deviation 25.5 | units on a scale | |
| Corneal Fluorescein Staining (CFS) | Meibomian Gland Probing Plus Lubricant | 2.4 | Standard Deviation 2.4 | units on a scale | |
| Corneal Fluorescein Staining (CFS) | Sham Meibomian Gland Probing Plus Lubricant | 2.0 | Standard Deviation 2.2 | units on a scale | |
| Corneal Fluorescein Staining (CFS) | Meibomian Gland Probing Plus Blephamide | 1.4 | Standard Deviation 2.1 | units on a scale | |
| Tear Break Up Time (TBUT) | Meibomian Gland Probing Plus Lubricant | 3.5 | Standard Deviation 2.4 | Seconds |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Meibomian Gland Probing Plus Lubricant | 15 | |
| Overall Study | STARTED | Sham Meibomian Gland Probing Plus Lubricant | 15 | |
| Overall Study | STARTED | Meibomian Gland Probing Plus Blephamide | 15 | |
| Overall Study | COMPLETED | Meibomian Gland Probing Plus Lubricant | 13 | |
| Overall Study | COMPLETED | Sham Meibomian Gland Probing Plus Lubricant | 14 | |
| Overall Study | COMPLETED | Meibomian Gland Probing Plus Blephamide | 14 | |
| Overall Study | NOT COMPLETED | Meibomian Gland Probing Plus Lubricant | 2 | |
| Overall Study | NOT COMPLETED | Sham Meibomian Gland Probing Plus Lubricant | 1 | |
| Overall Study | NOT COMPLETED | Meibomian Gland Probing Plus Blephamide | 1 |
Source ClinicalTrials.gov
Adverse events9
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 | Meibomian Gland Probing Plus Lubricant | 1 | 13 | |
| other | Eye Pain | Eye disorders | Sham Meibomian Gland Probing Plus Lubricant | 1 | 14 | |
| other | Eye Pain | Eye disorders | Meibomian Gland Probing Plus Blephamide | 2 | 14 | |
| other | Redness | Eye disorders | Meibomian Gland Probing Plus Lubricant | 0 | 13 | |
| other | Redness | Eye disorders | Sham Meibomian Gland Probing Plus Lubricant | 2 | 14 | |
| other | Redness | Eye disorders | Meibomian Gland Probing Plus Blephamide | 0 | 14 | |
| other | Foreign Body Sensation | Eye disorders | Meibomian Gland Probing Plus Lubricant | 0 | 13 | |
| other | Foreign Body Sensation | Eye disorders | Sham Meibomian Gland Probing Plus Lubricant | 0 | 14 | |
| other | Foreign Body Sensation | Eye disorders | Meibomian Gland Probing Plus Blephamide | 1 | 14 |
Source ClinicalTrials.gov
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Meibomian Gland Probing Plus Lubricant | 0 | 13 |
| Total, all-cause mortality | Sham Meibomian Gland Probing Plus Lubricant | 0 | 14 |
| Total, all-cause mortality | Meibomian Gland Probing Plus Blephamide | 0 | 14 |
| Total, other adverse events | Meibomian Gland Probing Plus Lubricant | 1 | 13 |
| Total, other adverse events | Sham Meibomian Gland Probing Plus Lubricant | 3 | 14 |
| Total, other adverse events | Meibomian Gland Probing Plus Blephamide | 3 | 14 |
| Total, serious adverse events | Meibomian Gland Probing Plus Lubricant | 0 | 13 |
| Total, serious adverse events | Sham Meibomian Gland Probing Plus Lubricant | 0 | 14 |
| Total, serious adverse events | Meibomian Gland Probing Plus Blephamide | 0 | 14 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32882429 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02256969
GET https://conductscience.org/api/trials/v1/NCT02256969/registered