Dry Eye SyndromesNCT03396809
Punctal Plugs and Iodine Related Discomfort
A study testing Punctal plug in people with Dry Eye Syndromes, run by University of New Mexico at 1 site in United States.
Trial summary
Purpose: Intravitreal injection of medications has revolutionized the treatment microvascular diseases. These diseases often require regular, life-long injections. Ensuring patient comfort is important for compliance with long-term treatments. 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 Syndromes
- What is being tested?
- Punctal plug
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2017to 7 Dec 2018
- Phase
- Interventional
- 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
- Patients seen at Eye Associates of New Mexico Retina Center or the University of New Mexico Eye Clinic
- Three consecutive monthly intravitreal injections
- Patients whose OSDI score indicate dry eye (score greater than 12)
- Greater than 18 years old
- Males and Females
Who cannot join
- previous punctal plugs
- punctal cautery
- active infection
- history of ocular infection
- herpes simplex virus
- herpes zoster virus
Show all 11Show fewer
- previous eyelid trauma
- surgery
- graft versus host disease
- and thyroid eye disease
- Women whom are pregnant or may become pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
Eye Associates of New Mexico Retina Center
Albuquerque, New Mexico, 87109
About this study
Official title: The Use of Punctal Plugs in Reducing Iodine Related Ocular Surface Discomfort
Purpose: Intravitreal injection of medications has revolutionized the treatment microvascular diseases. These diseases often require regular, life-long injections. Ensuring patient comfort is important for compliance with long-term treatments. Patients receiving regular intravitreal injections often complain of progressive dry eye related discomfort. These symptoms are likely secondary to the use of povidone iodine as an antiseptic. Investigators hypothesize that punctal plugs could reverse the progressive ocular surface discomfort induced by povidone iodine during the post-procedural state.
Read the detailed description
Retina specialists treat many diseases of the posterior segment of the eye by the delivery of medications via intravitreal injections. Many of these medications are monoclonal antibodies that need to be injected monthly. Endophthalmitis is a sight threatening complication of intravitreal injections. Limiting this complication is of primary importance in any injection protocol. The gold standard antiseptic used in intravitreal injection is Povidone-iodine (PI). PI is used to clean the surrounding ocular adnexa and is used in a 5% dilution on the ocular surface.
PI has been shown to be corrosive to the cornea, delay healing, and cause patients significant discomfort post injection especially for those with dry eye. Non-steroidal anti-inflammatories, topical anesthetics, and anticholinergics have been shown to decrease post injection discomfort1, but these measures are expensive, do not protect against corneal irritation and do not improve the healing capacity of the eye. There is a need for a cost effective measure that can reduce corneal irritation and improve healing due to the effects of PI. Punctal plugs are FDA approved for the treatment of dry eye. They increase lubrication of the eye by blocking the drainage of tears into the lacrimal sac. Our study would like to investigate the efficacy of punctal plug insertion in the prevention of dry eye symptoms caused by PI following intravitreal injection.
It has been shown that PI is toxic to the cornea at increasing concentrations. Once in contact with corneal epithelium it releases free iodine radicals causing cytotoxicity and apoptosis of cells. This makes it an effective antiseptic for Ophthalmologic procedures, but also causes significant destruction of the healthy corneal tissue2. It has also been shown in rabbits that calf serum is protective against PI induced corneal damage by providing an additional organic substrate for the PI to bind3. It is possible that natural tears can have a similar effect.
Punctal plugs are an extremely cost effective and widely used device to increase the volume of tears on the ocular surface. They block the lacrimal puncta and canalicular system that drains into the nasolacrimal duct, thereby inhibiting drainage of the natural tears into the nasal atria. In patients with dry eye who receive intravitreal injection punctal plugs may be useful in reducing corneal irritation by increasing the volume of natural tears on the ocular surface, which provides an additional organic substrate for the PI solution to bind. This has the potential to decrease the corrosive effects of the PI on the cornea, reduce healing time, and reduce pain in patients with dry eye.
Investigators will be performing a case crossover study. First patients who consent will be asked to complete an Ocular Surface Disease Index (OSDI). Those whose score indicates a diagnosis of dry eye will eligible for the study. Three to five days after their intravitreal injection, patients will be contacted over the telephone and asked to complete the OSDI. At their next visit, one month later, a punctal plug will be inserted before their second injection. Three to five days after their second injection, they will be asked to complete the OSDI over the telephone. At their third visit they will receive an intravitreal injection and three to five days after they will be asked to complete a final OSDI. If patients are receiving bilateral intravitreal injections, and the OSDI survey indicates dry eyes bilaterally, then only one of the eyes will be randomly chosen for plug insertion. The other eye will then be used as a control. There will be no blinding.
- Conditions
- Dry Eye Syndromes
- Being tested
- Punctal plug
- Keywords
- punctal plugs, dry eye, ocular surface disease index
- 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.
Punctal plugDevice
Punctal plugs are FDA approved for the treatment of dry eye. They increase lubrication of the eye by blocking the drainage of tears into the lacrimal sac. The nose portion of the plug has a larger diameter which is designed to fit in the canaliculum in order to retain the plug in the punctum. The plugs will be used on-label, as it is FDA approved in the treatment of dry eye. The purpose of punctal plugs are to increase tear volume by preventing drainage of tears into the lacrimal sac. The plugs are removable if necessary. Investigators are not testing this device for effectiveness or safety.
| Study group | Role | What they receive |
|---|---|---|
| Punctal Plugs | Experimental | This arm of the study receives punctal plug intervention. Receives: Device: Punctal plug |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in OSDI scores
For primary endpoints, investigators expect that participants will report reduced OSDI scores after intravitreal injection after insertion of punctal plug.
The Ocular Surface Disease Index, or OSDI, is a series of 12 questions associated with a scale that assesses dry eye disease. It has three subsections that investigate the symptoms, environmental factors, and functional limitations caused by dry eye. Each question has a 5 category Likert scale associated with it with five response options that range from "none of the time" to "all of the time." The final score is calculated by multiplying the sum of the scores by 25 and dividing by the total number of questions answered. A response between 0 and 12 represents normal, 13-22 mild, 23-32 moderate, and greater than 33 severe dry eye disease. The scores range from 0-100. The OSDI scores will be conducted by Elisabeth Sledz, in person after consent and over the telephone thereafter.
Measured: 1 year
Secondary outcomes (1)
OSDI scores in patients receiving bilateral injections
Patients receiving bilateral injections will be analyzed in a subgroup. Only one of their eyes will receive a punctal plug and the other will be used as a control. OSDI scores will be completed for both eyes.
The Ocular Surface Disease Index, or OSDI, is a series of 12 questions associated with a scale that assesses dry eye disease. It has three subsections that investigate the symptoms, environmental factors, and functional limitations caused by dry eye. Each question has a 5 category Likert scale associated with it with five response options that range from "none of the time" to "all of the time." The final score is calculated by multiplying the sum of the scores by 25 and dividing by the total number of questions answered. A response between 0 and 12 represents normal, 13-22 mild, 23-32 moderate, and greater than 33 sever dry eye disease. The scores range from 0-100. The OSDI scores will be conducted by Elisabeth Sledz, in person after consent and over the telephone.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start26 Jul 2017
- Primary completion7 Jul 2018
- Study completion7 Dec 2018
Why it stopped: PI left the institution. There are no publications for this research \& this is not Applicable Clinical Trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Investigators will be performing a case crossover study. First patients who consent will be asked to complete an Ocular Surface Disease Index (OSDI). Those whose score indicates a diagnosis of dry eye will eligible for the study. Three to five days after their intravitreal injection, patients will be contacted over the telephone and asked to complete the OSDI. At their next visit, one month later, a punctal plug will be inserted before their second injection. Three to five days after their second injection, they will be asked to complete the OSDI over the telephone. At their third visit they will receive an intravitreal injection and three to five days after they will be asked to complete a final OSDI. If patients are receiving bilateral intravitreal injections, and the OSDI survey indicates dry eyes bilaterally, then only one of the eyes will be randomly chosen for plug insertion. The other eye will then be used as a control.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of New Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Nelson, COA, ROUB, Study director, jjnelson@eyenm.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396809
- Sponsor's protocol ID
- MOD00006043
- Status last verified
- Mar 2024
- First submitted
- 20 Dec 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Publications
Georgakopoulos CD, Tsapardoni F, Makri OE. EFFECT OF BROMFENAC ON PAIN RELATED TO INTRAVITREAL INJECTIONS: A Randomized Crossover Study. Retina. 2017 Feb;37(2):388-395. doi: 10.1097/IAE.0000000000001137.
PubMed 27442130Jiang J, Wu M, Shen T. The toxic effect of different concentrations of povidone iodine on the rabbit's cornea. Cutan Ocul Toxicol. 2009;28(3):119-24. doi: 10.1080/15569520903080511.
PubMed 19694608Naor J, Savion N, Blumenthal M, Assia EI. Corneal endothelial cytotoxicity of diluted povidone--iodine. J Cataract Refract Surg. 2001 Jun;27(6):941-7. doi: 10.1016/s0886-3350(00)00750-1.
PubMed 11408145Haddock LJ, Ramsey DJ, Young LH. Complications of subspecialty ophthalmic care: endophthalmitis after intravitreal injections of anti-vascular endothelial growth factor medications. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):257-62. doi: 10.3109/08820538.2014.959616.
PubMed 25325851Jehangir N, Bever G, Mahmood SM, Moshirfar M. Comprehensive Review of the Literature on Existing Punctal Plugs for the Management of Dry Eye Disease. J Ophthalmol. 2016;2016:9312340. doi: 10.1155/2016/9312340. Epub 2016 Mar 7.
PubMed 27088009
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Punctal Plugs in Reducing Iodine Related Ocular Surface Discomfort
- ClinicalTrials.gov ID
- NCT03396809
- Acronym / sponsor ID
- MOD00006043
- Conditions
- Dry Eye Syndromes
- Keywords
- punctal plugs, dry eye, ocular surface disease index
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI left the institution. There are no publications for this research \& this is not Applicable Clinical Trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of New MexicoUniversity, hospital or other
- Study start
- 26 Jul 2017 (actual)
- Primary completion
- 7 Jul 2018 (actual)
- Study completion
- 7 Dec 2018 (actual)
- First posted
- 11 Jan 2018 (actual)
- 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.
Purpose: Intravitreal injection of medications has revolutionized the treatment microvascular diseases. These diseases often require regular, life-long injections. Ensuring patient comfort is important for compliance with long-term treatments. Patients receiving regular intravitreal injections often complain of progressive dry eye related discomfort. These symptoms are likely secondary to the use of povidone iodine as an antiseptic. Investigators hypothesize that punctal plugs could reverse the progressive ocular surface discomfort induced by povidone iodine during the post-procedural state.
Detailed description
Retina specialists treat many diseases of the posterior segment of the eye by the delivery of medications via intravitreal injections. Many of these medications are monoclonal antibodies that need to be injected monthly. Endophthalmitis is a sight threatening complication of intravitreal injections. Limiting this complication is of primary importance in any injection protocol. The gold standard antiseptic used in intravitreal injection is Povidone-iodine (PI). PI is used to clean the surrounding ocular adnexa and is used in a 5% dilution on the ocular surface.
PI has been shown to be corrosive to the cornea, delay healing, and cause patients significant discomfort post injection especially for those with dry eye. Non-steroidal anti-inflammatories, topical anesthetics, and anticholinergics have been shown to decrease post injection discomfort1, but these measures are expensive, do not protect against corneal irritation and do not improve the healing capacity of the eye. There is a need for a cost effective measure that can reduce corneal irritation and improve healing due to the effects of PI. Punctal plugs are FDA approved for the treatment of dry eye. They increase lubrication of the eye by blocking the drainage of tears into the lacrimal sac. Our study would like to investigate the efficacy of punctal plug insertion in the prevention of dry eye symptoms caused by PI following intravitreal injection.
It has been shown that PI is toxic to the cornea at increasing concentrations. Once in contact with corneal epithelium it releases free iodine radicals causing cytotoxicity and apoptosis of cells. This makes it an effective antiseptic for Ophthalmologic procedures, but also causes significant destruction of the healthy corneal tissue2. It has also been shown in rabbits that calf serum is protective against PI induced corneal damage by providing an additional organic substrate for the PI to bind3. It is possible that natural tears can have a similar effect.
Punctal plugs are an extremely cost effective and widely used device to increase the volume of tears on the ocular surface. They block the lacrimal puncta and canalicular system that drains into the nasolacrimal duct, thereby inhibiting drainage of the natural tears into the nasal atria. In patients with dry eye who receive intravitreal injection punctal plugs may be useful in reducing corneal irritation by increasing the volume of natural tears on the ocular surface, which provides an additional organic substrate for the PI solution to bind. This has the potential to decrease the corrosive effects of the PI on the cornea, reduce healing time, and reduce pain in patients with dry eye.
Investigators will be performing a case crossover study. First patients who consent will be asked to complete an Ocular Surface Disease Index (OSDI). Those whose score indicates a diagnosis of dry eye will eligible for the study. Three to five days after their intravitreal injection, patients will be contacted over the telephone and asked to complete the OSDI. At their next visit, one month later, a punctal plug will be inserted before their second injection. Three to five days after their second injection, they will be asked to complete the OSDI over the telephone. At their third visit they will receive an intravitreal injection and three to five days after they will be asked to complete a final OSDI. If patients are receiving bilateral intravitreal injections, and the OSDI survey indicates dry eyes bilaterally, then only one of the eyes will be randomly chosen for plug insertion. The other eye will then be used as a control. There will be no blinding.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Investigators will be performing a case crossover study. First patients who consent will be asked to complete an Ocular Surface Disease Index (OSDI). Those whose score indicates a diagnosis of dry eye will eligible for the study. Three to five days after their intravitreal injection, patients will be contacted over the telephone and asked to complete the OSDI. At their next visit, one month later, a punctal plug will be inserted before their second injection. Three to five days after their second injection, they will be asked to complete the OSDI over the telephone. At their third visit they will receive an intravitreal injection and three to five days after they will be asked to complete a final OSDI. If patients are receiving bilateral intravitreal injections, and the OSDI survey indicates dry eyes bilaterally, then only one of the eyes will be randomly chosen for plug insertion. The other eye will then be used as a control.
| Arm | Type | Receives |
|---|---|---|
| Punctal Plugs | Experimental | Device: Punctal plugThis arm of the study receives punctal plug intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients seen at Eye Associates of New Mexico Retina Center or the University of New Mexico Eye Clinic
- Three consecutive monthly intravitreal injections
- Patients whose OSDI score indicate dry eye (score greater than 12)
- Greater than 18 years old
- Males and Females
Key exclusion criteria (11 listed)
- previous punctal plugs
- punctal cautery
- active infection
- history of ocular infection
- previous eyelid trauma
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 |
|---|---|---|
| Punctal plugPunctal plugs are FDA approved for the treatment of dry eye. They increase lubrication of the eye by blocking the drainage of tears into the lacrimal sac. The nose portion of the plug has a larger diameter which is designed to fit in the canaliculum in order to retain the plug in the punctum. The plugs will be used on-label, as it is FDA approved in the treatment of dry eye. The purpose of punctal plugs are to increase tear volume by preventing drainage of tears into the lacrimal sac. The plugs are removable if necessary. Investigators are not testing this device for effectiveness or safety. | Device | Punctal Plugs |
Primary outcome
Reduction in OSDI scores
Time frame: 1 year
For primary endpoints, investigators expect that participants will report reduced OSDI scores after intravitreal injection after insertion of punctal plug. The Ocular Surface Disease Index, or OSDI, is a series of 12 questions associated with a scale that assesses dry eye disease. It has three subsections that investigate the symptoms, environmental factors, and functional limitations caused by dry eye. Each question has a 5 category Likert scale associated with it with five response options that range from "none of the time" to "all of the time." The final score is calculated by multiplying the sum of the scores by 25 and dividing by the total number of questions answered. A response between 0 and 12 represents normal, 13-22 mild, 23-32 moderate, and greater than 33 severe dry eye disease. The scores range from 0-100. The OSDI scores will be conducted by Elisabeth Sledz, in person after consent and over the telephone thereafter.
1 secondary outcome
OSDI scores in patients receiving bilateral injections
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Results publication: PubMed 27442130Georgakopoulos CD, Tsapardoni F, Makri OE. EFFECT OF BROMFENAC ON PAIN RELATED TO INTRAVITREAL INJECTIONS: A Randomized Crossover Study. Retina. 2017 Feb;37(2):388-395. doi: 10.1097/IAE.0000000000001137.
- Results publication: PubMed 19694608Jiang J, Wu M, Shen T. The toxic effect of different concentrations of povidone iodine on the rabbit's cornea. Cutan Ocul Toxicol. 2009;28(3):119-24. doi: 10.1080/15569520903080511.
- Results publication: PubMed 11408145Naor J, Savion N, Blumenthal M, Assia EI. Corneal endothelial cytotoxicity of diluted povidone--iodine. J Cataract Refract Surg. 2001 Jun;27(6):941-7. doi: 10.1016/s0886-3350(00)00750-1.
- Results publication: PubMed 25325851Haddock LJ, Ramsey DJ, Young LH. Complications of subspecialty ophthalmic care: endophthalmitis after intravitreal injections of anti-vascular endothelial growth factor medications. Semin Ophthalmol. 2014 Sep-Nov;29(5-6):257-62. doi: 10.3109/08820538.2014.959616.
- Results publication: PubMed 27088009Jehangir N, Bever G, Mahmood SM, Moshirfar M. Comprehensive Review of the Literature on Existing Punctal Plugs for the Management of Dry Eye Disease. J Ophthalmol. 2016;2016:9312340. doi: 10.1155/2016/9312340. Epub 2016 Mar 7.
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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.
Jennifer Nelson, COA, ROUB study director
jjnelson@eyenm.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Punctal plug in people with Dry Eye Syndromes, run by University of New Mexico 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 11 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: withdrawn, as of the sponsor's last update on 13 Mar 2024. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Reduction in OSDI scores (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03396809, which also lists 5 linked publications.
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 13 Mar 2024.