Dry Eye SyndromesNCT01826812
Impairment of Reading Ability in Dry Eye Patients
An observational study of Dry Eye Syndromes, run by Johns Hopkins University at 1 site in United States.
Trial summary
To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- 30 minutes sustained reading and Dry eye exam
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2015
- Phase
- Observational
- 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 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with known dry eye as well as normal healthy control subjects with no ocular surface diseases will be recruited from the Ocular Surface Diseases and Dry Eye Clinic as well as Glaucoma Clinic of the Wilmer Eye Institute.
Who may be able to join
- age of 50 or greater,
- literacy in English language,
- ability to give informed consent
Who cannot join
- binocular vision below 20/25,
- any ocular surgery within the last 3 months,
- mental issues,
- illiteracy,
- language problems which might possibly interfere with reading ability,
- history of taking or current use of topical prescription anti-inflammatory eye drops (including, cyclosporine and steroids as well as any glaucoma eye drops).
Trial locations and contacts
1 site in 1 country.
United States1 site
The Wilmer Eye Institute, Johns Hopkins University
Baltimore, Maryland, 21287
About this study
Official title: Functional Impairment of Reading Ability in Dry Eye Patients and Effects of Sustained Reading on the Ocular Surface
To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface.
Read the detailed description
This study is being done to understand how reading is affected in people with dry eye in comparison with healthy controls and what effect reading has on the ocular surface in patients with dry eye.
- Conditions
- Dry Eye Syndromes
- Being tested
- 30 minutes sustained reading, Dry eye exam
- 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.
30 minutes sustained readingOther
The participants will be given a text to read silently in 30 minutes.
Dry eye examOther
Tear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining.
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye | The patients with Sjogren Syndrome related or non-Sjogren Syndrome related dry eye. The participants will be asked some questions. Before and after reading a text silently in 30 minutes "30 minutes sustained reading", a detailed dry eye exam will be performed. Receives: Other: 30 minutes sustained reading; Other: Dry eye exam | |
| Controls | The patients without dry eye. The participants will be asked some questions. Before and after reading a text silently in 30 minutes "30 minutes sustained reading", a detailed dry eye exam will be performed. Receives: Other: 30 minutes sustained reading; Other: Dry eye exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Silent Reading Speed
Measured: 30 minutes
Secondary outcomes (4)
Change in Total Ocular Staining Score (OSS)
Ocular staining score (OSS) is sum of the corneal and conjuctival staining scores with a total possible maximum score of 12 for each eye. Corneal staining is graded with a maximum possible fluorescein score of 6 for each cornea (the punctate epithelial erosions grade between 0-3 plus any extra points for modifiers up to 3). Nasal and temporal conjunctiva are graded separately with a score range between 0 and 3 for each area after instillation of lissamine green. An abnormal OSS is defined as being a total score of 3 or more.
Measured: Before and after 30 minutes reading
Change in Tear Osmolarity
Measured: Before and after 30 minutes reading
Change in Visual Acuity
Measured: 30 minutes
Cytokines
Identification of various inflammatory cytokines in tear film of dry eye patients comparing to controls.
Measured: Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionNov 2015
- Study completionNov 2015
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 SyndromesStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan
- Responsible party
- Sponsor
- Investigators
- Esen K Akpek, MD, Principal investigator, The Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826812
- Sponsor's protocol ID
- NA_00082755
- Status last verified
- Aug 2017
- First submitted
- 4 Apr 2013
- Last updated
- 15 Feb 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional Impairment of Reading Ability in Dry Eye Patients and Effects of Sustained Reading on the Ocular Surface
- ClinicalTrials.gov ID
- NCT01826812
- Acronym / sponsor ID
- NA_00082755
- Conditions
- Dry Eye Syndromes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Allergan
- Study start
- Apr 2013
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 9 Apr 2013 (estimated)
- Results
- Posted 24 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the reading function impairment in patients with dry eye and to assess the effects of reading on the ocular surface.
Detailed description
This study is being done to understand how reading is affected in people with dry eye in comparison with healthy controls and what effect reading has on the ocular surface in patients with dry eye.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Eye | – | Other: 30 minutes sustained reading, Other: Dry eye examThe patients with Sjogren Syndrome related or non-Sjogren Syndrome related dry eye. The participants will be asked some questions. Before and after reading a text silently in 30 minutes "30 minutes sustained reading", a detailed dry eye exam will be performed. |
| Controls | – | Other: 30 minutes sustained reading, Other: Dry eye examThe patients without dry eye. The participants will be asked some questions. Before and after reading a text silently in 30 minutes "30 minutes sustained reading", a detailed dry eye exam will be performed. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with known dry eye as well as normal healthy control subjects with no ocular surface diseases will be recruited from the Ocular Surface Diseases and Dry Eye Clinic as well as Glaucoma Clinic of the Wilmer Eye Institute.
Key inclusion criteria (3 listed)
- age of 50 or greater,
- literacy in English language,
- ability to give informed consent
Key exclusion criteria (6 listed)
- binocular vision below 20/25,
- any ocular surgery within the last 3 months,
- mental issues,
- illiteracy,
- language problems which might possibly interfere with reading ability,
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 |
|---|---|---|
| 30 minutes sustained readingThe participants will be given a text to read silently in 30 minutes. | Other | Controls, Dry Eye |
| Dry eye examTear break-up time, tear collection, osmolarity, Schirmer test, corneal and conjunctival staining. | Other | Controls, Dry Eye |
Primary outcome
Sustained Silent Reading Speed
Time frame: 30 minutes
4 secondary outcomes
Change in Total Ocular Staining Score (OSS)
Time frame: Before and after 30 minutes reading
Change in Tear Osmolarity
Time frame: Before and after 30 minutes reading
Change in Visual Acuity
Time frame: 30 minutes
Cytokines
Time frame: Tear samples were collected on the day of the exam. The samples were frozen to be assayed upon completion of the study.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Esen K Akpek, MD principal investigator
The Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye Syndromes, run by Johns Hopkins University 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 3 inclusion and 6 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 Feb 2018. 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 24 Mar 2016). 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?
Sustained Silent Reading Speed (time frame: 30 minutes). 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 Feb 2018.