Dry Eye SyndromePhase 4AKORNNCT02758327
Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops
A Phase 4 study testing TheraTears Lubricating Eye Drops in people with Dry Eye Syndrome, run by Koffler Vision Group.
Trial summary
The objective of the study is to demonstrate a change in osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears lubricating drops. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Dry Eye Syndrome
- What is being tested?
- TheraTears Lubricating Eye Drops
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Mar 2016
- Phase
- Phase 4
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Is at least 21 years of age and has full legal capacity to volunteer;
- Has read and signed the information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye;
- Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye or a osmolarity reading of at least 308 (in worse eye) and at least an 8 point difference between the two eyes.
Who cannot join
- Has taken part in another research study within the last 30 days;
- Planned contact lens wear during the course of the study;
- Staff at the investigational site or family member of site staff or family member of currently enrolled participant;
- Any subject that violates the washout period by using eye drops during the 72hrs washout period;
- Has any known ocular disease* including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome;
- Restasis use can be included if they have been on it for at least 3 months and are stable.Used Restasis (or similar topical medication) within the last 6 months;
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- Has a systemic condition that in the opinion of the investigator may affect the dry eye status of the subject, especially those newly diagnosed, newly prescribed and/or unstable;
- Is pregnant, lactating or planning a pregnancy at the time of enrolment (verbal confirmation necessary);
- Use of systemic anti-histamines, as long as they have been on them continuously for at least 1 month. Use of medications such as: Systemic Antihistamine (e.g., Allegra®, Benadryl®, Claritin®, Dimetapp®, Unisom®, Zyrtec®, etc.), Isotretinoin (e.g., Accutane®, Roaccutane®, Amnesteem®, Claravis®, Isotroin®, Sotret®) or similar medications;
- Has known sensitivity to the diagnostic pharmaceuticals to be used in the study;
- Has undergone ocular surgery(LASIK, Cataract, etc)within the last year;
- For purposes of this study, ocular conditions that are typically associated with dry eye status, such as meibomian gland dysfunction, mild (i.e. not considered clinically relevant) blepharitis, corneal and conjunctival staining are not considered an exclusion.
About this study
Official title: Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating
The objective of the study is to demonstrate a change in osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears lubricating drops.
Read the detailed description
Symptomatic dry eye subjects exhibited a significantly higher tear osmolarity than observed in normal subjects, this is thought to relate to the inherent tear film instability of dry eye disease. Lubricating eye drops are frequently prescribed to relieve the symptoms of dry eye.
- Conditions
- Dry Eye Syndrome
- Being tested
- TheraTears Lubricating Eye Drops
- Keywords
- Tear Osmolarity, Keratitis Sicca, Ocular Surface Disease, TheraTears
- Medical subject headings
- Dry Eye Syndromes, Keratitis sicca
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TheraTears Lubricating Eye DropsDrug
Also called 87049747
Sodium Carboxy-methylcellulose 0.25% eye Lubricant
| Study group | Role | What they receive |
|---|---|---|
| TheraTears Lubrication Drop | Experimental | TheraTears Lubricating Eye Drops to be instilled 1 drop in both eyes 4 times per day over a period of 8 weeks. Receives: Drug: TheraTears Lubricating Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tear Osmolarity
Osmolarity measures will be evaluated using the eye with the highest osmolarity reading at the washout/baseline visit. These baseline values will be compared to subsequent follow-up visits, to determine change from baseline at each visit as well as cumulative change in osmolarity over time.
Measured: 8 weeks
Secondary outcomes (4)
Change in Visual Acuity
Visual acuity measures will be evaluated using the eye with the highest osmolarity reading at the washout/baseline visit. These baseline values will be compared to subsequent follow-up visits, to determine change from baseline at each visit as well as cumulative change in visual acuity over time.
Measured: 8 weeks
Change in Tear Film Breakup Time
After instillation of fluorescein, the investigator will ask the participant blink three times and keep their eyes open for as long as they can while the investigator records the time at which the dark spots on the tear film begin to appear.
Measured: 8 Weeks
Change in Corneal Staining
A fluorescein strip will be wetted with a few drops of saline, and applied to the inferior palpebral conjunctiva of both eyes. The eye will be illuminated by cobalt blue light, and viewed through a Wratten no. 12 barrier filter. Fluorescein staining will be assessed using the CCLRU8 scale (0 to 4).
Measured: 8 weeks
Change in Conjunctiva Staining
A lissamine green strip will be wetted and applied to the inferior palpebral conjunctiva of both eyes to assess conjunctival staining. Lissamine conjunctival staining will be assessed using the Oxford scale. If lissamine strip is not available, fluorescein maybe used instead to assess all conjunctival staining.
Measured: 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study startOct 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Koffler Vision Group
- Sponsor type
- University, hospital or other
- Collaborators
- Akorn, Inc.
- Responsible party
- Sponsor
- Investigators
- Diane Houtman, MD, Study director, Akorn Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02758327
- Sponsor's protocol ID
- ACH_PM_101_14
- Acronym
- AKORN
- Status last verified
- Aug 2017
- First submitted
- 27 Apr 2016
- Last updated
- 18 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating
- ClinicalTrials.gov ID
- NCT02758327
- Acronym / sponsor ID
- AKORN / ACH_PM_101_14
- Conditions
- Dry Eye Syndrome
- Keywords
- Tear Osmolarity, Keratitis Sicca, Ocular Surface Disease, TheraTears
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Koffler Vision GroupUniversity, hospital or other
- Collaborators
- Akorn, Inc.
- Study start
- Oct 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 2 May 2016 (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 objective of the study is to demonstrate a change in osmolarity over time when moderate to severe dry eye subjects are treated with TheraTears lubricating drops.
Detailed description
Symptomatic dry eye subjects exhibited a significantly higher tear osmolarity than observed in normal subjects, this is thought to relate to the inherent tear film instability of dry eye disease. Lubricating eye drops are frequently prescribed to relieve the symptoms of dry eye.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TheraTears Lubrication Drop | Experimental | Drug: TheraTears Lubricating Eye DropsTheraTears Lubricating Eye Drops to be instilled 1 drop in both eyes 4 times per day over a period of 8 weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Is at least 21 years of age and has full legal capacity to volunteer;
- Has read and signed the information consent letter;
- Is willing and able to follow instructions and maintain the appointment schedule;
- Is diagnosed with dry eye syndrome (in at least one eye), indicated by current ocular examination, prior history (self-reported history of dry eye is acceptable) and current use of treatments for dry eye;
- Has a minimum osmolarity reading of 316 mosm/kg at the baseline visit in at least one eye or a osmolarity reading of at least 308 (in worse eye) and at least an 8 point difference between the two eyes.
Key exclusion criteria (12 listed)
- Has taken part in another research study within the last 30 days;
- Planned contact lens wear during the course of the study;
- Staff at the investigational site or family member of site staff or family member of currently enrolled participant;
- Any subject that violates the washout period by using eye drops during the 72hrs washout period;
- Has any known ocular disease* including active ocular infection, inflammation or allergy, especially Salzmann's nodular degeneration, symptomatic conjunctivochalasis, and fixation disparity syndrome;
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 |
|---|---|---|
| TheraTears Lubricating Eye DropsAlso: 87049747Sodium Carboxy-methylcellulose 0.25% eye Lubricant | Drug | TheraTears Lubrication Drop |
Primary outcome
Change in Tear Osmolarity
Time frame: 8 weeks
Osmolarity measures will be evaluated using the eye with the highest osmolarity reading at the washout/baseline visit. These baseline values will be compared to subsequent follow-up visits, to determine change from baseline at each visit as well as cumulative change in osmolarity over time.
4 secondary outcomes
Change in Visual Acuity
Time frame: 8 weeks
Change in Tear Film Breakup Time
Time frame: 8 Weeks
Change in Corneal Staining
Time frame: 8 weeks
Change in Conjunctiva Staining
Time frame: 8 Weeks
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 18 Aug 2017.
- 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.
Diane Houtman, MD study director
Akorn Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing TheraTears Lubricating Eye Drops in people with Dry Eye Syndrome, run by Koffler Vision Group.
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 12 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 18 Aug 2017. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Change in Tear Osmolarity (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 18 Aug 2017.