Trial · NCT00514852
Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
NCT00514852, Not applicable, Completed, Allergan; results first posted 2009-12-15
3 sourcestrials-2026-11-12-0.5.0
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Cite this record
ConductScience Library. Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye. Trials, record NCT00514852. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00514852
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
- NCT number
- NCT00514852
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 316 participants, actual
- Lead sponsor
- Allergan
- Conditions
- Dry Eye Syndrome
- Interventions
- Carboxymethylcellulose and Glycerin based artificial tear, Carboxymethylcellulose
- First posted
- 2007-08-10
- Last updated
- 2009-12-15
- Results first posted
- 2009-12-15
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Change from baseline at Day 30 | Ocular Surface Disease Index© Questionnaire Score is measured on 12 domains; a 5-point scale (0-4) for each domain. Sum of the domain scores is normalized to a severity scale of 0-100 (0 = no symptoms, 100 = maximum severity) |
| Secondary | Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Change from baseline at Day 30 | Schirmer Test measures the rate of the secretion of tears |
| Secondary | Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Change from baseline at Day 30 | Measures the stability of tear film. The average of 3 measures. |
| Secondary | Patient Acceptability Score (Dryness) at Day 30 | Day 30 | Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all). |
| Secondary | Patient Acceptability Score (Vision) at Day 30 | Day 30 | Vision Quality Visual Analog Scale is measured on a 0-100 point scale (0 = very poor, has never been worse, 100 = excellent, has never been better). |
| Secondary | Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein | Change from baseline at Day 30 | Sum of corneal staining over 5 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-25 (0= no staining, 25 = most severe staining) |
| Secondary | Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein | Change from baseline at Day 30 | Sum of conjunctival staining over 6 zones; each zone was measured on a modified Oxford Scheme of 0-5 (0=no staining, 5=most severe staining), with total score from 0-30 (0=no staining, 30=most severe staining) |
| Secondary | Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score | Change from baseline at Day 30 | Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe) |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Change from baseline at Day 30 | Intent to Treat Population (Modified) | Units on a scale | MEAN |
| SECONDARY | Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Change from baseline at Day 30 | Intent to Treat Population | mm/5min | MEAN |
| SECONDARY | Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein | Change from baseline at Day 30 | Intent to Treat Population | seconds | MEAN |
| SECONDARY | Patient Acceptability Score (Dryness) at Day 30 | Day 30 | Intent to Treat Population | Units on scale | MEAN |
| SECONDARY | Patient Acceptability Score (Vision) at Day 30 | Day 30 | Intent to treat population | Units on a scale | MEAN |
| POST_HOC | Vision Subscale of the Ocular Surface Disease Index Questionnaire© at Day 30 | Day 30 | Intent to Treat Population (Modified) | Units on a scale | MEAN |
| POST_HOC | Ocular Surface Staining With Fluorescein (Central Cornea) at Day 30 | Day 30 | Intent to Treat Population | Units on a scale | MEAN |
| SECONDARY | Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein | Change from baseline at Day 30 | Intent to Treat Population | Units on a scale | MEAN |
| SECONDARY | Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein | Change from baseline at Day 30 | Intent to Treat Population | Units on a scale | MEAN |
| SECONDARY | Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score | Change from baseline at Day 30 | Intent to Treat Population | Units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group60
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Carboxymethylcellulose and Glycerin Based Artificial Tear | Day 1 (Baseline) | 44 | Standard Deviation 18.1 | Units on a scale |
| Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Carboxymethylcellulose Based Artificial Tear | Day 1 (Baseline) | 45.2 | Standard Deviation 18.3 | Units on a scale |
| Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Carboxymethylcellulose and Glycerin Based Artificial Tear | Day 7 | -12.6 | Standard Deviation 14.9 | Units on a scale |
| Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Carboxymethylcellulose Based Artificial Tear | Day 7 | -13.6 | Standard Deviation 17.8 | Units on a scale |
| Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Carboxymethylcellulose and Glycerin Based Artificial Tear | Day 30 | -16.3 | Standard Deviation 16.4 | Units on a scale |
| Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score | Carboxymethylcellulose Based Artificial Tear | Day 30 | -16.6 | Standard Deviation 20.3 | Units on a scale |
| Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Carboxymethylcellulose and Glycerin Based Artificial Tear | Day 1 (Baseline) | 9.2 | Standard Deviation 7.2 | mm/5min |
| Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Carboxymethylcellulose Based Artificial Tear | Day 1 (Baseline) | 8.6 | Standard Deviation 6.8 | mm/5min |
| Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Carboxymethylcellulose and Glycerin Based Artificial Tear | Day 7 | 1.2 | Standard Deviation 5.1 | mm/5min |
| Change From Baseline at Day 30 in Schirmer Test, With Anesthesia | Carboxymethylcellulose Based Artificial Tear | Day 7 | 1.2 | Standard Deviation 5.6 | mm/5min |
1 to 10 of 60Source ClinicalTrials.gov
See all 60 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 and Glycerin Based Artificial Tear | 157 | |
| Overall Study | STARTED | Carboxymethylcellulose Based Artificial Tear | 159 | |
| Overall Study | COMPLETED | Carboxymethylcellulose and Glycerin Based Artificial Tear | 152 | |
| Overall Study | COMPLETED | Carboxymethylcellulose Based Artificial Tear | 154 | |
| Overall Study | NOT COMPLETED | Carboxymethylcellulose and Glycerin Based Artificial Tear | 5 | |
| Overall Study | NOT COMPLETED | Carboxymethylcellulose Based Artificial Tear | 5 |
Source ClinicalTrials.gov
Adverse events4
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 |
|---|---|---|---|---|---|---|
| serious | Transient Ischaemic Attack | Nervous system disorders | Carboxymethylcellulose and Glycerin Based Artificial Tear | 1 | 157 | |
| serious | Transient Ischaemic Attack | Nervous system disorders | Carboxymethylcellulose Based Artificial Tear | 0 | 159 | |
| serious | Menorrhagia | Reproductive system and breast disorders | Carboxymethylcellulose and Glycerin Based Artificial Tear | 0 | 157 | |
| serious | Menorrhagia | Reproductive system and breast disorders | Carboxymethylcellulose Based Artificial Tear | 1 | 159 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Carboxymethylcellulose and Glycerin Based Artificial Tear | ||
| Total, all-cause mortality | Carboxymethylcellulose Based Artificial Tear | ||
| Total, other adverse events | Carboxymethylcellulose and Glycerin Based Artificial Tear | 0 | 157 |
| Total, other adverse events | Carboxymethylcellulose Based Artificial Tear | 0 | 159 |
| Total, serious adverse events | Carboxymethylcellulose and Glycerin Based Artificial Tear | 1 | 157 |
| Total, serious adverse events | Carboxymethylcellulose Based Artificial Tear | 1 | 159 |
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 and Glycerin Based Artificial Tear vs Carboxymethylcellulose Based Artificial Tear: 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/NCT00514852
GET https://conductscience.org/api/trials/v1/NCT00514852/results?page=2