Dry Eye SyndromeNCT00514852
Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
A study testing Carboxymethylcellulose and Glycerin based artificial tear and Carboxymethylcellulose in people with Dry Eye Syndrome, run by Allergan at 1 site in United States.
Trial summary
The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- Carboxymethylcellulose and Glycerin based artificial tear and Carboxymethylcellulose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 316 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Jan 2008
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mild, moderate or Severe Symptoms of Dry Eye
Who cannot join
- Uncontrolled systemic disease
- Use of systemic medications affecting dry eye
- Pregnancy or planning a pregnancy
- Contact lens wear
Trial locations and contacts
1 site in 1 country.
About this study
The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear
- Conditions
- Dry Eye Syndrome
- Being tested
- Carboxymethylcellulose and Glycerin based artificial tear, Carboxymethylcellulose
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carboxymethylcellulose and Glycerin based artificial tearDrug
1 to 2 drops into each eye as needed but at least twice daily
CarboxymethylcelluloseDrug
Also called Refresh Plus
1 to 2 drops into each eye as needed but at least twice daily
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Carboxymethylcellulose and Glycerin based artificial tear Receives: Drug: Carboxymethylcellulose and Glycerin based artificial tear |
| 2 | Active comparator | Carboxymethylcellulose Receives: Drug: Carboxymethylcellulose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
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)
Measured: Change from baseline at Day 30
Secondary outcomes (7)
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Schirmer Test measures the rate of the secretion of tears
Measured: Change from baseline at Day 30
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Measures the stability of tear film. The average of 3 measures.
Measured: Change from baseline at Day 30
Patient Acceptability Score (Dryness) at Day 30
Dryness Severity Visual Analog Scale is measured on a 0-100 point scale (0 = could not be worse, 100 = none at all).
Measured: Day 30
Patient Acceptability Score (Vision) at 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).
Measured: Day 30
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
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)
Measured: Change from baseline at Day 30
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
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)
Measured: Change from baseline at Day 30
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score
Measures dry eye severity on a scale of 0-4 (0 = none, 4 = severe)
Measured: Change from baseline at Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startOct 2007
- Primary completionJan 2008
- Study completionJan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Dry Eye SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 316 participants (actual)
Sponsor and investigators
- Lead sponsor
- Allergan
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Medical Director, Study director, Allergan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514852
- Sponsor's protocol ID
- AG9818-002
- Status last verified
- Nov 2009
- First submitted
- 8 Aug 2007
- Last updated
- 15 Dec 2009
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of an Artificial Tear for the Treatment of Dry Eye
- ClinicalTrials.gov ID
- NCT00514852
- Acronym / sponsor ID
- AG9818-002
- Conditions
- Dry Eye Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 316 participants (actual)
- Lead sponsor
- AllerganIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Posted 15 Dec 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The efficacy, safety and acceptability of a new artificial tear in subjects with dry eye will be compared to a currently-available artificial tear
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Carboxymethylcellulose and Glycerin based artificial tearCarboxymethylcellulose and Glycerin based artificial tear |
| 2 | Active comparator | Drug: CarboxymethylcelluloseCarboxymethylcellulose |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Mild, moderate or Severe Symptoms of Dry Eye
Key exclusion criteria (4 listed)
- Uncontrolled systemic disease
- Use of systemic medications affecting dry eye
- Pregnancy or planning a pregnancy
- Contact lens wear
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carboxymethylcellulose and Glycerin based artificial tear1 to 2 drops into each eye as needed but at least twice daily | Drug | 1 |
| CarboxymethylcelluloseAlso: Refresh Plus1 to 2 drops into each eye as needed but at least twice daily | Drug | 2 |
Primary outcome
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score
Time frame: 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)
7 secondary outcomes
Change From Baseline at Day 30 in Schirmer Test, With Anesthesia
Time frame: Change from baseline at Day 30
Change From Baseline at Day 30 in Tear Break-Up Time, With Fluorescein
Time frame: Change from baseline at Day 30
Patient Acceptability Score (Dryness) at Day 30
Time frame: Day 30
Patient Acceptability Score (Vision) at Day 30
Time frame: Day 30
Change From Baseline at Day 30 in Ocular Surface (Corneal) Staining With Fluorescein
Time frame: Change from baseline at Day 30
Change From Baseline at Day 30 in Ocular Surface (Conjunctival) Staining With Fluorescein
Time frame: Change from baseline at Day 30
Change From Baseline at Day 30 in Subjective Evaluation of Symptom of Dryness Score
Time frame: Change from baseline at Day 30
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Allergan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carboxymethylcellulose and Glycerin based artificial tear and Carboxymethylcellulose in people with Dry Eye Syndrome, run by Allergan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline at Day 30 in Ocular Surface Disease Index© Questionnaire Score (time frame: Change from baseline at Day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2009.