Dry EyePhase 2/3NCT02701764
Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?
A Phase 2/3 study testing Pregabalin in people with Dry Eye, run by University of Miami at 1 site in United States.
Trial summary
Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery? Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Pregabalin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2016to 1 Dec 2018
- Phase
- Phase 2/3
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 and 65 years of age
- undergoing LASIK (unilateral or bilateral procedure).
- Females of child-bearing age will need a negative urine or serum pregnancy test at the screening visit.
- ocular and systemic medication regimen has been stable for 3 months
Who cannot join
- Pregnant or lactating, participating in another study with an investigational drug within one month prior to screening
- Using gabapentin, pregabalin, anti-convulsants, duloxetine, venlafaxine (SNRI), or tri-cyclic antidepressants
- have a history of allergic, anaphylactic reaction, or severe systemic response to pregabalin or gabapentin
- use corticosteroids chronically or during the month prior to surgery, or have a history of corneal disease (HSV or varicella zoster keratitis, prior corneal incisions (cataract surgery, radial keratotomy, LASIK), prior corneal ulcer).
- patients with systemic co-morbidities that may confound DE such as HIV, sarcoidosis, graft-versus host disease or a collagen vascular disease.
- Adults unable to consent
- Individuals who are not yet adults (infants, children, teenagers)
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery?
Read the detailed description
Dry eye symptoms can occur after LASIK surgery. They generally get better with time but in some patients, they can persist. The investigators believe that in some individuals, dry eye symptoms after LASIK persist because the nerves in the cornea become hypersensitive. The investigators wish to study if a medication, called pregabalin, can protect corneal nerves at the time of LASIK surgery and decrease the frequency and severity of dry eye symptoms 6 months after surgery. This medication has been used in a similar way to reduce the frequency of uncomfortable sensations after other surgeries (knee, abdomen) but has never been studied in LASIK surgery.
- Conditions
- Dry Eye
- Being tested
- Pregabalin, Placebo
- Keywords
- laser-assisted in situ keratomileusis, dry eye symptoms, LASIK, prevention
- 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.
PregabalinDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Pregabalin | Experimental | Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Receives: Drug: Pregabalin |
| Placebo | Placebo comparator | Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye. Absolute score will be reported from DEQ5 questionnaire completed at 6 month visit.
Measured: 6 months
Secondary outcomes (7)
Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)
OSDI total score ranges from 0-100 with a higher score indicating greater disability. Absolute scores will be reported from OSDI questionnaire completed at 3 and 6 month visit.
Measured: 3 months, 6 months
Tear Production Measured by Schirmers Score
Tear production will be measured via Schirmers score. Schirmer strips will be placed in the outer 1/3 of the lower conjunctivae. The Schirmer score will be evaluated as the length of wetting in mm in the Schirmer strips after 5 minutes. Absolute scores will be reported for the tear production evaluation at the 3 and 6 months visit.
Measured: 3 months, 6 months
Tear Evaporation Measured by Tear Break up Time (TBUT)
Participant will have 5 μl of preservative free fluorescein placed on their eye. The participant will then be positioned in the head rest of the slit lamp instrument and will be instructed to blink three times naturally and then not blink. The integrity of the tear film will be measured and, using a stopwatch, the time from the last blink until one or more black (dry) spots appear in the precorneal tear film will be recorded as TBUT. The absolute scores for TBUT completed on the 3 and 6 month visit will be reported.
Measured: 3 months, 6 months
Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E)
NPSI-E total score ranges from 0-100 with a higher score indicating increased eye pain. Absolute scores will be reported from NPSI-Eye questionnaire completed at 3 and 6 month visit.
Measured: 3 months, 6 months
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory
sf-MPQ Sensory has a total score ranging from 0-33 with a higher score indicating increased pain. Absolute scores will be reported from sf-MPQ Sensory questionnaire completed at 3 and 6 month visit.
Measured: 3 months, 6 months
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective
sf-MPQ Affective has a total score ranging from 0-12 with a higher score indicating increased pain. Absolute scores will be reported from sf-MPQ Affective questionnaire completed at 3 and 6 month visit.
Measured: 3 months, 6 months
Eye Pain as Assessed by the Numeric Rating Scale (NRS)
NRS total score ranges from 0-10 over a one week recall period with the higher score indicating increased pain. Absolute scores will be reported from NRS questionnaire completed at 3 and 6 month visit.
Measured: 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study start26 Jul 2016
- Primary completion1 Dec 2018
- Study completion1 Dec 2018
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- More trials run by University of MiamiThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anat Galor, University of Miami
- Investigators
- Anat Galor, MD, MSPH, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701764
- Sponsor's protocol ID
- 20160095
- Status last verified
- Nov 2019
- First submitted
- 26 Feb 2016
- Last updated
- 14 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Levitt AE, Galor A, Weiss JS, Felix ER, Martin ER, Patin DJ, Sarantopoulos KD, Levitt RC. Chronic dry eye symptoms after LASIK: parallels and lessons to be learned from other persistent post-operative pain disorders. Mol Pain. 2015 Apr 21;11:21. doi: 10.1186/s12990-015-0020-7.
PubMed 25896684Levitt AE, Galor A, Small L, Feuer W, Felix ER. Pain sensitivity and autonomic nervous system parameters as predictors of dry eye symptoms after LASIK. Ocul Surf. 2021 Jan;19:275-281. doi: 10.1016/j.jtos.2020.10.004. Epub 2020 Oct 21.
PubMed 33096271
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Pregabalin Reduce the Frequency and Severity of Dry Eye Symptoms After Laser-assisted in Situ Keratomileusis?
- ClinicalTrials.gov ID
- NCT02701764
- Acronym / sponsor ID
- 20160095
- Conditions
- Dry Eye
- Keywords
- laser-assisted in situ keratomileusis, dry eye symptoms, LASIK, prevention
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 26 Jul 2016 (actual)
- Primary completion
- 1 Dec 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 8 Mar 2016 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery?
Detailed description
Dry eye symptoms can occur after LASIK surgery. They generally get better with time but in some patients, they can persist. The investigators believe that in some individuals, dry eye symptoms after LASIK persist because the nerves in the cornea become hypersensitive. The investigators wish to study if a medication, called pregabalin, can protect corneal nerves at the time of LASIK surgery and decrease the frequency and severity of dry eye symptoms 6 months after surgery. This medication has been used in a similar way to reduce the frequency of uncomfortable sensations after other surgeries (knee, abdomen) but has never been studied in LASIK surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregabalin | Experimental | Drug: PregabalinPregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 and 65 years of age
- undergoing LASIK (unilateral or bilateral procedure).
- Females of child-bearing age will need a negative urine or serum pregnancy test at the screening visit.
- ocular and systemic medication regimen has been stable for 3 months
Key exclusion criteria (8 listed)
- Pregnant or lactating, participating in another study with an investigational drug within one month prior to screening
- Using gabapentin, pregabalin, anti-convulsants, duloxetine, venlafaxine (SNRI), or tri-cyclic antidepressants
- have a history of allergic, anaphylactic reaction, or severe systemic response to pregabalin or gabapentin
- use corticosteroids chronically or during the month prior to surgery, or have a history of corneal disease (HSV or varicella zoster keratitis, prior corneal incisions (cataract surgery, radial keratotomy, LASIK), prior corneal ulcer).
- patients with systemic co-morbidities that may confound DE such as HIV, sarcoidosis, graft-versus host disease or a collagen vascular disease.
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 |
|---|---|---|
| Pregabalin | Drug | Pregabalin |
| Placebo | Drug | Placebo |
Primary outcome
Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5)
Time frame: 6 months
DEQ5 total score ranges from 0-22 with the higher scores indicating increased dry eye. Absolute score will be reported from DEQ5 questionnaire completed at 6 month visit.
7 secondary outcomes
Dry Eye Symptoms as Evaluated by the Ocular Surface Disease Index (OSDI)
Time frame: 3 months, 6 months
Tear Production Measured by Schirmers Score
Time frame: 3 months, 6 months
Tear Evaporation Measured by Tear Break up Time (TBUT)
Time frame: 3 months, 6 months
Eye Pain as Evaluated by the Neuropathic Pain Symptom Inventory - Eye (NPSI-E)
Time frame: 3 months, 6 months
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Sensory
Time frame: 3 months, 6 months
Eye Pain as Assessed by the Short Form - McGill Pain Questionnaire (Sf-MPQ) Affective
Time frame: 3 months, 6 months
Eye Pain as Assessed by the Numeric Rating Scale (NRS)
Time frame: 3 months, 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 25896684Levitt AE, Galor A, Weiss JS, Felix ER, Martin ER, Patin DJ, Sarantopoulos KD, Levitt RC. Chronic dry eye symptoms after LASIK: parallels and lessons to be learned from other persistent post-operative pain disorders. Mol Pain. 2015 Apr 21;11:21. doi: 10.1186/s12990-015-0020-7.
- Derived from this study: PubMed 33096271Levitt AE, Galor A, Small L, Feuer W, Felix ER. Pain sensitivity and autonomic nervous system parameters as predictors of dry eye symptoms after LASIK. Ocul Surf. 2021 Jan;19:275-281. doi: 10.1016/j.jtos.2020.10.004. Epub 2020 Oct 21.
- Individual participant dataSharing planned: No
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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.
Anat Galor, MD, MSPH principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Pregabalin in people with Dry Eye, run by University of Miami 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 8 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 14 Nov 2019. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). 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?
Severity of Dry Eye Symptoms as Assessed by the Dry Eye Questionnaire - 5 (DEQ5) (time frame: 6 months). 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 NCT02701764, which also lists 2 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 14 Nov 2019.