Trial · NCT00681265
Tear Film Break-up Time After Instillation of Artificial Tears
NCT00681265, Not applicable, Completed, Calm Water Therapeutics LLC; results first posted 2012-10-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Tear Film Break-up Time After Instillation of Artificial Tears. Trials, record NCT00681265. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00681265
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Tear Film Break-up Time After Instillation of Artificial Tears
- NCT number
- NCT00681265
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 16 participants, actual
- Lead sponsor
- Calm Water Therapeutics LLC
- Conditions
- Keratoconjunctivitis Sicca
- Interventions
- glycerin, polyethylene glycol 400/propylene glycol
- First posted
- 2008-05-21
- Last updated
- 2012-10-26
- Results first posted
- 2012-10-26
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Noninvasive Tear Film Break-up Time | 15 minutes after eye drop instillation | State-of-the-art methodology to assess tear stability. |
| Secondary | Fluorescein Tear Film Break-up Time | 120 minutes after eye drops instillation | Standard clinical assessment methodology for assessing tear stability. |
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 | Noninvasive Tear Film Break-up Time | 15 minutes after eye drop instillation | Study N determined empirically by PI. | seconds | MEAN |
| SECONDARY | Fluorescein Tear Film Break-up Time | 120 minutes after eye drops instillation | Study N determined empirically by PI. | seconds | MEAN |
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 |
|---|---|---|---|---|---|
| Noninvasive Tear Film Break-up Time | New Formulation of Glycerin 1% Eye Drop | 14.67 | Standard Deviation 27.21 | seconds | |
| Noninvasive Tear Film Break-up Time | Propylene Glycol and PEG 400 Eye Drop | 7.4 | Standard Deviation 30.30 | seconds | |
| Fluorescein Tear Film Break-up Time | New Formulation of Glycerin 1% Eye Drop | 11.13 | Standard Deviation 12.08 | seconds | |
| Fluorescein Tear Film Break-up Time | Propylene Glycol and PEG 400 Eye Drop | 6.21 | Standard Deviation 4.86 | seconds |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop | 16 | |
| Overall Study | COMPLETED | Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop | 16 | |
| Overall Study | NOT COMPLETED | Glycerin Eye Drop / PEG 400 and Propylene Glycol Eye Drop | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | New Formulation of Glycerin 1% Eye Drop | ||
| Total, all-cause mortality | Propylene Glycol and PEG 400 Eye Drop | ||
| Total, other adverse events | New Formulation of Glycerin 1% Eye Drop | 0 | 16 |
| Total, other adverse events | Propylene Glycol and PEG 400 Eye Drop | 0 | 16 |
| Total, serious adverse events | New Formulation of Glycerin 1% Eye Drop | 0 | 16 |
| Total, serious adverse events | Propylene Glycol and PEG 400 Eye Drop | 0 | 16 |
Source ClinicalTrials.gov
Papers3
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| New Formulation of Glycerin 1% Eye Drop vs Propylene Glycol and PEG 400 Eye Drop: serious adverse events |
Source 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/NCT00681265
GET https://conductscience.org/api/trials/v1/NCT00681265/registered