Dry EyePhase 3NCT01335126
Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears
A Phase 3 study testing Emulsion type artificial tear in people with Dry Eye, run by Hom, Milton M., OD, FAAO.
Trial summary
The purpose of this study is to evaluate the performance between two emulsion-type artificial tears. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Emulsion type artificial tear
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Mar 2011to Nov 2011
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Between the ages of 18 and over inclusive.
- Males or females
- Patient is in generally good \& stable overall health.
- Patient likely to comply with study guidelines \& study visits.
- Informed consent signed.
- OSDI score >18 OR
- TBUT <10 seconds
Who cannot join
- Corneal refractive surgery or contact lens wear within 6 months of this study.
- Current use of Restasis
- Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- Pregnant or lactating women.
- Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
About this study
The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.
- Conditions
- Dry Eye
- Being tested
- Emulsion type artificial tear
- Keywords
- Artificial tears
- 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.
Emulsion type artificial tearOther
2 types of artificial tears
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Not described Receives: Other: Emulsion type artificial tear |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tolerability Questionnaire
Tolerability (comfort) measured with Visual Analog scale (1 to 100)
Measured: 8 weeks
Secondary outcomes (2)
Acceptability Questionnaire
Acceptability questionnaire on statements regarding drop satisfaction, etc. Answered as A to E (Strongly Agree, Agree, Neither Agree or Disagree, Disagree or Strongly Disagree)
Measured: 8 weeks
Tear Break Up Time
Tear Break Up Time measured in seconds
Measured: 2-3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2011 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Allergan
- Investigators
- Milton M Hom, OD FAAO, Principal investigator, Private Practice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01335126
- Sponsor's protocol ID
- AG9965-007
- Status last verified
- Apr 2011
- First submitted
- 12 Apr 2011
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Tolerability and Clinical Performance of Two Emulsion-type Artificial Tears
- ClinicalTrials.gov ID
- NCT01335126
- Acronym / sponsor ID
- AG9965-007
- Conditions
- Dry Eye
- Keywords
- Artificial tears
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hom, Milton M., OD, FAAO
- Collaborators
- Allergan
- Study start
- Mar 2011
- Primary completion
- Oct 2011 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 14 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance between two emulsion-type artificial tears.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Other: Emulsion type artificial tear |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Between the ages of 18 and over inclusive.
- Males or females
- Patient is in generally good \& stable overall health.
- Patient likely to comply with study guidelines \& study visits.
- Informed consent signed.
Key exclusion criteria (5 listed)
- Corneal refractive surgery or contact lens wear within 6 months of this study.
- Current use of Restasis
- Intra-ocular surgery within 6 months or ocular laser surgery within 6 months.
- Pregnant or lactating women.
- Ocular pathology (includes glaucoma and cataract), which could impact results and/or place patient at risk.
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 |
|---|---|---|
| Emulsion type artificial tear2 types of artificial tears | Other | Test |
Primary outcome
Tolerability Questionnaire
Time frame: 8 weeks
Tolerability (comfort) measured with Visual Analog scale (1 to 100)
2 secondary outcomes
Acceptability Questionnaire
Time frame: 8 weeks
Tear Break Up Time
Time frame: 2-3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
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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.
Milton M Hom, OD FAAO principal investigator
Private Practice
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Emulsion type artificial tear in people with Dry Eye, run by Hom, Milton M., OD, FAAO.
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 7 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Tolerability Questionnaire (time frame: 8 weeks). 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 14 Apr 2011.