Trial · NCT00938704
Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
NCT00938704, Phase 4, Completed, Allergan; results first posted 2011-10-31
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms. Trials, record NCT00938704. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00938704
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Compare the Efficacy and Safety of Two Non-Preserved Artificial Tears for the Treatment of Dry Eye Signs and Symptoms
- NCT number
- NCT00938704
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 71 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Dry Eye Syndromes
- Interventions
- carboxymethylcellulose 0.5% +glycerin 0.9%, sodium hyaluronate 0.18%
- First posted
- 2009-07-14
- Last updated
- 2011-10-31
- Results first posted
- 2011-10-31
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 | Baseline, Week 2 | Change from baseline in OSDI at Week 2. The OSDI consists of 12 questions measuring the presence of ocular symptoms. Each of the 12 questions is assessed using a 5-point scale (0=none of the time; 4=all of the time). The score is converted to a 0-100 score where 0 is best and 100 is worst. Higher OSDI scores are associated with greater severity. A negative number change from baseline indicates improvement. |
| Secondary | Change From Baseline in Tear Breakup Time (TBUT) at Week 2 | Baseline, Week 2 | Change from baseline in TBUT at Week 2. TBUT is defined as the time required for dry spots to appear on the surface of the eye after blinking. The longer it takes, the more stable the tear film. A positive number change from baseline indicates improvement. |
| Secondary | Change From Baseline in Corneal Staining at Week 2 | Baseline, Week 2 | Change from baseline in corneal staining at Week 2. Staining of the cornea following ocular administration of fluorescein dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. |
| Secondary | Change From Baseline in Conjunctival Staining (Temporal) at Week 2 | Baseline, Week 2 | Change from baseline in conjunctival (temporal) staining at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. |
| Secondary | Change From Baseline in Conjunctival Staining (Nasal) at Week 2 | Baseline, Week 2 | Change from baseline in conjunctival staining (nasal) at Week 2. Staining of the conjunctiva following ocular administration of lissamine green dye was graded using a 6-point scale (0=no staining, 5=diffuse staining). The higher the grade score, the worse the dry eye severity. A negative number change from baseline indicates improvement. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 | Baseline, Week 2 | Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized). | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline in Tear Breakup Time (TBUT) at Week 2 | Baseline, Week 2 | Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized). | Seconds | MEAN |
| SECONDARY | Change From Baseline in Corneal Staining at Week 2 | Baseline, Week 2 | Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized). | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline in Conjunctival Staining (Temporal) at Week 2 | Baseline, Week 2 | Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized). | Scores on a Scale | MEAN |
| SECONDARY | Change From Baseline in Conjunctival Staining (Nasal) at Week 2 | Baseline, Week 2 | Intent-to-Treat (ITT). The ITT population consisted of all patients who started the study (randomized). | Scores on a Scale | MEAN |
Source ClinicalTrials.gov
Results by group20
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Baseline | 56.06 | Standard Deviation 13.43 | Scores on a Scale |
| Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 | Sodium Hyaluronate 0.18% | Baseline | 54.292 | Standard Deviation 13.100 | Scores on a Scale |
| Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Week 2 | -27.048 | Standard Deviation 17.87 | Scores on a Scale |
| Change From Baseline in Ocular Surface Disease Index (OSDI) at Week 2 | Sodium Hyaluronate 0.18% | Week 2 | -28.303 | Standard Deviation 21.821 | Scores on a Scale |
| Change From Baseline in Tear Breakup Time (TBUT) at Week 2 | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Baseline | 6.501 | Standard Deviation 1.73 | Seconds |
| Change From Baseline in Tear Breakup Time (TBUT) at Week 2 | Sodium Hyaluronate 0.18% | Baseline | 5.914 | Standard Deviation 1.646 | Seconds |
| Change From Baseline in Tear Breakup Time (TBUT) at Week 2 | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Week 2 | 2.919 | Standard Deviation 2.388 | Seconds |
| Change From Baseline in Tear Breakup Time (TBUT) at Week 2 | Sodium Hyaluronate 0.18% | Week 2 | 2.538 | Standard Deviation 2.923 | Seconds |
| Change From Baseline in Corneal Staining at Week 2 | Carboxymethylcellulose 0.5%, Glycerin 0.9% | Baseline | 1.818 | Standard Deviation 0.779 | Scores on a Scale |
| Change From Baseline in Corneal Staining at Week 2 | Sodium Hyaluronate 0.18% | Baseline | 1.608 | Standard Deviation 0.936 | Scores on a Scale |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Carboxymethylcellulose 0.5%, Glycerin 0.9% | 33 | |
| Overall Study | STARTED | Sodium Hyaluronate 0.18% | 37 | |
| Overall Study | COMPLETED | Carboxymethylcellulose 0.5%, Glycerin 0.9% | 33 | |
| Overall Study | COMPLETED | Sodium Hyaluronate 0.18% | 37 | |
| Overall Study | NOT COMPLETED | Carboxymethylcellulose 0.5%, Glycerin 0.9% | 0 | |
| Overall Study | NOT COMPLETED | Sodium Hyaluronate 0.18% | 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 | Carboxymethylcellulose 0.5%, Glycerin 0.9% | ||
| Total, all-cause mortality | Sodium Hyaluronate 0.18% | ||
| Total, other adverse events | Carboxymethylcellulose 0.5%, Glycerin 0.9% | 0 | 33 |
| Total, other adverse events | Sodium Hyaluronate 0.18% | 0 | 37 |
| Total, serious adverse events | Carboxymethylcellulose 0.5%, Glycerin 0.9% | 0 | 33 |
| Total, serious adverse events | Sodium Hyaluronate 0.18% | 0 | 37 |
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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Carboxymethylcellulose 0.5%, Glycerin 0.9% vs Sodium Hyaluronate 0.18%: 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/NCT00938704
GET https://conductscience.org/api/trials/v1/NCT00938704/registered