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Can Lyrica (Pregabalin) help prevent severe Dry Eye post LASIK surgery?
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pregabalin | Experimental | Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. |
|
| Placebo | Placebo Comparator | Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pregabalin | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months, 6 months |
| Tear Production Measured by Schirmers Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anat Galor, MD, MSPH | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anat Galor | Miami | Florida | 33133 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25896684 | Background | 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. | |
| 33096271 | Derived | Levitt 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pregabalin | Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin |
| FG001 | Placebo | Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pregabalin | Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin |
| BG001 | Placebo | Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | One participant in the placebo group did not complete 6 month visit | Posted | Mean | Standard Deviation | score on a scale | 6 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pregabalin | Pregabalin 150 mg twice a day starting 1 day prior to LASIK and continuing for 14 days total. Pregabalin |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tiredness | General disorders | MedDRA (22.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Anat Galor | University of Miami | 305-450-6050 | agalor@med.miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 23, 2017 | Aug 9, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D000069583 | Pregabalin |
| ID | Term |
|---|---|
| D005680 | gamma-Aminobutyric Acid |
| D000613 | Aminobutyrates |
| D002087 | Butyrates |
| D000144 | Acids, Acyclic |
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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. |
| 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. | 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. | 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. | 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. | 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. | 3 months, 6 months |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | 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. | One participant in the placebo group did not complete the 6 month visit. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months |
|
|
|
| Secondary | 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. | One participant in the placebo group did not complete the 6 month visit | Posted | Mean | Standard Deviation | mm wetting | 3 months, 6 months |
|
|
|
| Secondary | 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. | One participant in the placebo group did not complete 6 month visit | Posted | Mean | Standard Deviation | Seconds | 3 months, 6 months |
|
|
|
| Secondary | 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. | One participant in the placebo group did not complete the 6 month visit. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months |
|
|
|
| Secondary | 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. | One participant in the placebo group did not complete the 6 month visit. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months |
|
|
|
| Secondary | 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. | One participant in the placebo group did not complete the 6 month visit. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months |
|
|
|
| Secondary | 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. | One participant in the placebo group did not complete the 6 month visit. | Posted | Mean | Standard Deviation | score on a scale | 3 months, 6 months |
|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| 13 |
| 21 |
| EG001 | Placebo | Placebo pill twice a day starting 1 day prior to LASIK and continuing for 14 days total. Placebo | 0 | 22 | 0 | 22 | 10 | 22 |
| Dizziness | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (22.0) | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Dry mouth | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| Bloating | Gastrointestinal disorders | MedDRA (22.0) | Systematic Assessment |
|
| High or elevated mood | Psychiatric disorders | MedDRA (22.0) | Systematic Assessment |
|
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| D002264 |
| Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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| 6 months |
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