Dry EyeEarly Phase 1NCT01375582
Objective Evaluation of Ocular Surface Lubricants in Two Environments
A Early Phase 1 study testing B & L Soothe Lubricant Eye Drops, Liposic EDO and OcuFresh Eye Wash in people with Dry Eye, run by University of Rochester at 1 site in United States.
Trial summary
This study will evaluate ocular surface lubricants in subjects with dry eye syndrome. Read more about this study
- Who is it for?
- Ages 30 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- B & L Soothe Lubricant Eye Drops, Liposic EDO and OcuFresh Eye Wash
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Jun 2012
- Phase
- Early Phase 1
- 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 30 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 30-75 years
- Good general health
- Willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits
- Currently using an OTC artificial tear for ocular comfort, at least occasionally.
- At least one positive dry eye symptom.
Who cannot join
- Current eye disease, infection or inflammation that requires the use of any prescription ocular medication.
- Recent past eye surgery.
- Female subjects may not be pregnant or lactating.
- Infectious diseases
Trial locations and contacts
1 site in 1 country.
United States1 site
Flaum Eye Institute at the University of Rochester
Rochester, New York, 14642
About this study
Official title: Objective Evaluation of Ocular Surface Lubricants
This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.
Read the detailed description
This study will objectively evaluate ocular surface lubricants in subjects with dry eye syndrome. Lubricants contain compounds that are purported to improve dry eye symptoms, although objective data is not available. The investigators seek to objectively evaluate the effectiveness of two lubricants and compare the results to a saline eye drop (control).
The investigators will assess the lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using the ellipsometry, imaging in a "normal" environment. Subsequently the investigators will change the environment to one that causes the subjects' ocular surface to experience "evaporative stress" (warmer, less humid and greater air flow) and perform the before and after drop administration measurements with the same three products in the same eye as the first environment.
- Conditions
- Dry Eye
- Being tested
- B & L Soothe Lubricant Eye Drops, Liposic EDO, OcuFresh Eye Wash
- Keywords
- Dry Eye, tear film, lipid, tear volume, environmental chamber, thermal imaging
- 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.
B & L Soothe Lubricant Eye DropsDrug
Eye Drop
Liposic EDODrug
Eye Drop
OcuFresh Eye WashDrug
Saline drop
| Study group | Role | What they receive |
|---|---|---|
| Drop Administration | Experimental | Not described Receives: Drug: B & L Soothe Lubricant Eye Drops; Drug: Liposic EDO; Drug: OcuFresh Eye Wash |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tear Film Properties
The wavefront sensor instrument measures the eye's ability to create a sharp image.
Ellipsometer (E) data identifies changes in lipid thickness and refractive index over the cornea.
A thermal (T) imaging system provides thermal maps of the subject's eyes and face adjacent to the eyes.
A questionnaire (Q) will ask subjects about their test eye's comfort. Subjects will be asked the questions prior to instillation of the eye drop and after each set of measurements.
Measured: Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2011 (estimated)
- Study startJun 2011
- Primary completionJun 2012
- Study completionJun 2012
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 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
- NCT01375582
- Sponsor's protocol ID
- 35809
- Status last verified
- Nov 2022
- First submitted
- 14 Jun 2011
- Last updated
- 22 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Evaluation of Ocular Surface Lubricants
- ClinicalTrials.gov ID
- NCT01375582
- Acronym / sponsor ID
- 35809
- Conditions
- Dry Eye
- Keywords
- Dry Eye, tear film, lipid, tear volume, environmental chamber, thermal imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Bausch & Lomb Incorporated
- Study start
- Jun 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 17 Jun 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.
This study will evaluate ocular surface lubricants in subjects with dry eye syndrome.
Detailed description
This study will objectively evaluate ocular surface lubricants in subjects with dry eye syndrome. Lubricants contain compounds that are purported to improve dry eye symptoms, although objective data is not available. The investigators seek to objectively evaluate the effectiveness of two lubricants and compare the results to a saline eye drop (control).
The investigators will assess the lipid layer before and after the administration of three products in the same eye of 25 dry eye subjects using the ellipsometry, imaging in a "normal" environment. Subsequently the investigators will change the environment to one that causes the subjects' ocular surface to experience "evaporative stress" (warmer, less humid and greater air flow) and perform the before and after drop administration measurements with the same three products in the same eye as the first environment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Drop Administration | Experimental | Drug: B & L Soothe Lubricant Eye Drops, Drug: Liposic EDO, Drug: OcuFresh Eye Wash |
Who may qualify
- Ages
- 30 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 30-75 years
- Good general health
- Willing to spend time for the study; approximately one hour for a screening visit and 90 minutes for each of the measurement visits
- Currently using an OTC artificial tear for ocular comfort, at least occasionally.
- At least one positive dry eye symptom.
Key exclusion criteria (4 listed)
- Current eye disease, infection or inflammation that requires the use of any prescription ocular medication.
- Recent past eye surgery.
- Female subjects may not be pregnant or lactating.
- Infectious diseases
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 |
|---|---|---|
| B & L Soothe Lubricant Eye DropsEye Drop | Drug | Drop Administration |
| Liposic EDOEye Drop | Drug | Drop Administration |
| OcuFresh Eye WashSaline drop | Drug | Drop Administration |
Primary outcome
Tear Film Properties
Time frame: Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit.
The wavefront sensor instrument measures the eye's ability to create a sharp image. Ellipsometer (E) data identifies changes in lipid thickness and refractive index over the cornea. A thermal (T) imaging system provides thermal maps of the subject's eyes and face adjacent to the eyes. A questionnaire (Q) will ask subjects about their test eye's comfort. Subjects will be asked the questions prior to instillation of the eye drop and after each set of measurements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2022.
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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.
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 Early Phase 1 study testing B & L Soothe Lubricant Eye Drops, Liposic EDO and OcuFresh Eye Wash in people with Dry Eye, 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 5 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 22 Nov 2022. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Tear Film Properties (time frame: Measurements: There is no time restriction between the screening and 1st measurement. 6 measurement visits occur approximately 7 days apart but can range from 3 to 14 days. The time between visit 3 and 4 are not be closer than 3 days, but no upper limit.). 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 22 Nov 2022.