Aqueous Deficient Dry EyeNCT01128049
Non-invasive Tear Film Dynamic Measurements in Normal, MGD and ADDE Subjects After Saline Instillation
A study testing Subjective Questionnaire, Measurement with wavefront sensor (right eye, then left eye) and Instill Saline Drop in people with Aqueous Deficient Dry Eye and Meibomium Gland Dysfunction, run by University of Rochester at 1 site in United States.
Trial summary
Compare the objective tear film dynamic measurements in three different populations (MGD [Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry eye]) and the subjective experience before and after instilling a single drop of saline in each eye. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aqueous Deficient Dry Eye, Meibomium Gland Dysfunction
- What is being tested?
- Subjective Questionnaire, Measurement with wavefront sensor (right eye, then left eye) and Instill Saline Drop
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2011
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Cohort Specific Inclusion Criteria:
- ADDE cohort: Schirmer I < 10 mm, BUT ¬< 5 seconds, Fluorescein 0 or 1, currently using an artificial tear for ocular comfort at least occasionally.
- MGD cohort: Diagnosis of moderate or severe MGD
- Normal/Control (Non Dry-Eye): meets general inclusion and exclusion criteria
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Flaum Eye Institute-University of Rochester
Rochester, New York, 14642
About this study
Official title: Non-invasive Tear Film Dynamic Measurements in Normal, MGD (Meibomium Gland Dysfunction) and Aqueous Deficient Dry Eye(ADDE) Subjects After Saline Instillation
Compare the objective tear film dynamic measurements in three different populations (MGD [Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry eye]) and the subjective experience before and after instilling a single drop of saline in each eye.
Currently available office-based tests for dry eye do not reliably correlate with patients' subjective symptoms. This study is interested in assessing how individuals with these two different ocular surface diseases compare with the normal population when measured objectively using two different instruments.
Read the detailed description
There will be one study day with a single visit that will consist of taking two sets of measurements. Baseline measurements are taken in both eyes using a wavefront sensor to measure visual quality followed by saline instillation. Five minutes after drops, visual quality is again measured to evaluate changes in tear dynamics.
- Being tested
- Subjective Questionnaire, Measurement with wavefront sensor (right eye, then left eye), Instill Saline Drop
- Keywords
- Aqueous deficient dry eye (ADDE), Meibomium Gland Dysfunction (MGD), Normal/Control (Non Dry Eye)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subjective QuestionnaireBehavioural
The team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop.
Measurement with wavefront sensor (right eye, then left eye)Procedure or surgery
The wavefront instrument measures the eye's ability to create a sharp image by briefly shining a laser light from the wavefront sensor into the eye and measuring the light that bounces back through the cornea. For these measurements, subjects will sit on a chair and be instructed to place their chin in a chin rest and lean their forehead against a forehead rest. The subject will be instructed to hold his/her head steady, look in a certain direction, blink or not blink. We will obtain the measurements over a short period of up to approximately 45 seconds. We will start recording data asking the subject to either blink naturally or to hold his/her eye open for a few (up to 10) seconds, and repeat the blink and hold sequence usually for up to four times.
Instill Saline DropDrug
Also called Ocufresh eye wash
One drop will be instilled in both eyes and patient will wait 5 minutes prior to repeating the questionnaire and wavefront sensor. A single drop is approximately 30 µL and will be placed into the inferior cul-de-sac while the patient looks up.
| Study group | Role | What they receive |
|---|---|---|
| Normal Patient Population | Active comparator | Non-Dry Eye patient population (intervention remains the same across all arms) Receives: Behavioral: Subjective Questionnaire; Procedure: Measurement with wavefront sensor (right eye, then left eye); Drug: Instill Saline Drop |
| MGD Patient Population | Active comparator | Meibomium Gland Dysfunction population(intervention remains the same across all arms) Receives: Behavioral: Subjective Questionnaire; Procedure: Measurement with wavefront sensor (right eye, then left eye); Drug: Instill Saline Drop |
| ADDE Population | Active comparator | Aqueous Deficient Dry Eye population(intervention remains the same across all arms) Receives: Behavioral: Subjective Questionnaire; Procedure: Measurement with wavefront sensor (right eye, then left eye); Drug: Instill Saline Drop |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Quality
Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities.
Measured: 5 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2011
- Study completionDec 2011
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 Aqueous Deficient Dry EyeStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Responsible party
- Principal investigator, James V. Aquavella, MD, University of Rochester
- Investigators
- James V Aquavella, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01128049
- Sponsor's protocol ID
- B&L 32280
- Status last verified
- Aug 2015
- First submitted
- 19 May 2010
- Last updated
- 7 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Tear Film Dynamic Measurements in Normal, MGD (Meibomium Gland Dysfunction) and Aqueous Deficient Dry Eye(ADDE) Subjects After Saline Instillation
- ClinicalTrials.gov ID
- NCT01128049
- Acronym / sponsor ID
- B&L 32280
- Keywords
- Aqueous deficient dry eye (ADDE), Meibomium Gland Dysfunction (MGD), Normal/Control (Non Dry Eye)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Jun 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 21 May 2010 (estimated)
- Results
- Posted 11 Jun 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare the objective tear film dynamic measurements in three different populations (MGD [Meibomium Gland Dysfunction], ADDE [Aqueous Deficient Dry Eye] and normal/control [non-dry eye]) and the subjective experience before and after instilling a single drop of saline in each eye.
Currently available office-based tests for dry eye do not reliably correlate with patients' subjective symptoms. This study is interested in assessing how individuals with these two different ocular surface diseases compare with the normal population when measured objectively using two different instruments.
Detailed description
There will be one study day with a single visit that will consist of taking two sets of measurements. Baseline measurements are taken in both eyes using a wavefront sensor to measure visual quality followed by saline instillation. Five minutes after drops, visual quality is again measured to evaluate changes in tear dynamics.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Patient Population | Active comparator | Behavioral: Subjective Questionnaire, Procedure: Measurement with wavefront sensor (right eye, then left eye), Drug: Instill Saline DropNon-Dry Eye patient population (intervention remains the same across all arms) |
| MGD Patient Population | Active comparator | Behavioral: Subjective Questionnaire, Procedure: Measurement with wavefront sensor (right eye, then left eye), Drug: Instill Saline DropMeibomium Gland Dysfunction population(intervention remains the same across all arms) |
| ADDE Population | Active comparator | Behavioral: Subjective Questionnaire, Procedure: Measurement with wavefront sensor (right eye, then left eye), Drug: Instill Saline DropAqueous Deficient Dry Eye population(intervention remains the same across all arms) |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ADDE cohort: Schirmer I < 10 mm, BUT ¬< 5 seconds, Fluorescein 0 or 1, currently using an artificial tear for ocular comfort at least occasionally.
- MGD cohort: Diagnosis of moderate or severe MGD
- Normal/Control (Non Dry-Eye): meets general inclusion and exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Subjective QuestionnaireThe team will use a one page questionnaire to obtain subjective input before the first set of measurements and after instilling the Saline drop. | Behavioural | ADDE Population, MGD Patient Population, Normal Patient Population |
| Measurement with wavefront sensor (right eye, then left eye)The wavefront instrument measures the eye's ability to create a sharp image by briefly shining a laser light from the wavefront sensor into the eye and measuring the light that bounces back through the cornea. For these measurements, subjects will sit on a chair and be instructed to place their chin in a chin rest and lean their forehead against a forehead rest. The subject will be instructed to hold his/her head steady, look in a certain direction, blink or not blink. We will obtain the measurements over a short period of up to approximately 45 seconds. We will start recording data asking the subject to either blink naturally or to hold his/her eye open for a few (up to 10) seconds, and repeat the blink and hold sequence usually for up to four times. | Procedure or surgery | ADDE Population, MGD Patient Population, Normal Patient Population |
| Instill Saline DropAlso: Ocufresh eye washOne drop will be instilled in both eyes and patient will wait 5 minutes prior to repeating the questionnaire and wavefront sensor. A single drop is approximately 30 µL and will be placed into the inferior cul-de-sac while the patient looks up. | Drug | ADDE Population, MGD Patient Population, Normal Patient Population |
Primary outcome
Visual Quality
Time frame: 5 seconds
Average visual quality change over a 5 second blink cycle caused by movement of the tears over the surface of the eye by measuring optical irregularities.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Aqueous Deficient Dry Eye
Recruiting
Upper Punctal Plug Occlusion in Previous Lower Punctal Occlusion.
DED, Aqueous-deficient Dry Eye Disease
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.
James V Aquavella, MD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subjective Questionnaire, Measurement with wavefront sensor (right eye, then left eye) and Instill Saline Drop in people with Aqueous Deficient Dry Eye and Meibomium Gland Dysfunction, run by University of Rochester 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 4 inclusion and 0 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 7 Aug 2015. 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 11 Jun 2015). 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?
Visual Quality (time frame: 5 seconds). 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 7 Aug 2015.