Dry EyeNCT05895500
Evaluate the Safety and Efficacy of Calcitonin Gene-Related Peptide (CGRP) Antagonists in Patients With Dry Eye Disease and Asthenopia
An observational study of Dry Eye and Asthenopia, run by Nvision Laser Eye Centers at 1 site in United States.
Trial summary
Safety and Efficacy of Medications for Migraine in Patients with Dry Eye Disease or Asthenopia 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, Asthenopia
- What is being tested?
- Injection for SC administration (120mg/syringe) and Tablet (50mg/tablet), oral
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2023to 9 Nov 2023
- How long will I take part?
- 56 Days
- Phase
- Observational
- 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
Study population: Subjects will be selected from the clinical database that have previous symptoms and/or chief complaints of dry eye syndrome and asthenopia.
Who may be able to join
- Able to understand the key components of the study as described in the written ICF, and willing and able to provide written informed consent.
- Male or female ≥ 18 years of age.
- Clinical diagnosis of:
- Dry eye disease with episodes of eye discomfort in at least 4 of the previous 28 days during medical history assessment at Screening Visit, and have intensity >40 mm on a VAS scale at Screening (Day -28) visit OR
- Asthenopia with episodes of eye discomfort in at least 4 of previous 28 days during medical assessment at Screening Visit and have intensity > 40 mm on a VAS scale at Screening (Day -28) visit. The cause of asthenopia should be recorded.
- Willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
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- Agree not to participate in another interventional study while on treatment.
- If female, is surgically sterile or 2 years postmenopausal. Women of childbearing potential may be enrolled if a urine pregnancy test is negative at Screening and at Baseline Visits. Women of childbearing potential and men with partners who are of childbearing potential must agree to use highly effective methods of contraception from Screening throughout the study. Contraception use must continue for 90 days after the last administration of the study drug. Examples of acceptable methods of contraception which must be used together are described in Section 14.
- If male, agrees to use a medically accepted highly effective method of contraception, agrees to use this method for 90 days after last administration of the study drug, and agrees to not donate sperm for 90 days after last administration of the study drug
- Agree not to change lifestyle significantly during this study (Day -28 to Day 28).
Who cannot join
- Active ocular infection or ocular inflammatory disease other than dry eye disease
- Presence of anterior membrane dystrophy or history of clinically significant recurrent erosion syndrome.
- Significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
- Prior radial keratotomy at any time or prior laser refractive surgery within the past 12 months of Screening Visit.
- Unable to discontinue any over the counter (OTC), herbal, or systemic administration (including transdermal applications) of opioids or treatments for neuropathic pain (e.g., gabapentin or pregabalin, tetrahydrocannabinol) during the study on Days -28 to +28.
- Seated blood pressure > 140 mmHg (systolic) or > 90 mmHg (diastolic).
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- History (within the past 30 days) or currently taking strong or moderate cytochrome P450 3A4 (CYP3A4) inhibitors (e.g., itraconazole, ketoconazole, fluconazole; erythromycin, clarithromycin, telithromycin; diltiazem, verapamil; aprepitant, cyclosporine, grapefruit juice, and HIV protease inhibitors), strong or moderate CYP3A4 inducers (e.g., barbiturates, primidone, mitotane, enzalutamide, efavirenz, apalutamide, carbamazepine, phenytoin, rifampin, , and St. John's wort), inhibitors of the BCRP (breast cancer resistance protein) transporter (e.g., curcumin and eltrombopag), and/or P-gp inhibitors (e.g., clarithromycin, quinidine, and cyclosporine), or drugs with narrow therapeutic margins (e.g., digoxin, warfarin). For a more complete list see FDA https://www.fda.gov/drugs/drug-interactions-labeling/drug- development and-drug-interactions-table-substrates-inhibitors-and-inducers#table5-2 (August 24, 2022).
- Pregnant or plans to become pregnant and/or patients who are breastfeeding or plan to breastfeed during the study.
- Current malignancy or a history of malignancy (within the past 5 years), except non metastatic basal or squamous cell carcinoma of the skin that has been treated successfully.
- Significant liver disease, defined as having elevated aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels greater than 1.5 times the upper value of the normal range of the laboratory OR total bilirubin greater than 1.5 mg/dL (except for patients with a diagnosis of Gilbert's disease) OR serum albumin less than 2.8 g/dL at Screening Visit.
- History of any other acute or chronic medical condition or pre-planned medical/surgical procedure that, in the opinion of the Investigator, would compromise the safety of the patient or the integrity of study results.
- History of acute hepatitis within 6 months of Screening Visit or chronic hepatitis (including nonalcoholic steatohepatitis) or a positive result on anti-hepatitis A immunoglobulin M (IgM) antibody, hepatitis B surface antigen, or anti-hepatitis C antibody testing at Screening Visit.
- Concurrent participation in another interventional study or treatment with an investigational drug up to 30 days or 5 half-lives (depending on medication) prior to Screening Visit.
- Any form of substance abuse, psychiatric disorder, or a condition that, in the opinion of the Investigator, could invalidate communication with the Investigator during the study.
- Positive test result for drugs of abuse at Screening Visit.
- Unable to have a stable routine at home and workplace during the study.
- The Principal Investigator reserves the right to declare a patient ineligible based on medical evidence that indicates the patient is unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Investigator-Initiated Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of CGRP Antagonists in Patients With Dry Eye Disease and Asthenopia
Safety and Efficacy of Medications for Migraine in Patients with Dry Eye Disease or Asthenopia
Read the detailed description
An Investigator-Initiated Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Medications for Migraine in Patients with Dry Eye Disease or Asthenopia
- Conditions
- Dry Eye, Asthenopia
- Being tested
- Injection for SC administration (120mg/syringe), Tablet (50mg/tablet), oral
- Medical subject headings
- Dry Eye Syndromes, Asthenopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection for SC administration (120mg/syringe)Drug
Injection
Tablet (50mg/tablet), oralDrug
Tablet
| Study group | Role | What they receive |
|---|---|---|
| Tablet | Tablets (50mg/tablet), oral Receives: Drug: Tablet (50mg/tablet), oral | |
| Injection | Injection for SC administration (120mg/syringe) Receives: Drug: Injection for SC administration (120mg/syringe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tablet group
Improvement in Symptoms: Number of days that a participant feels improvement in subjective symptoms of eye discomfort due to DED or asthenopia after oral administration of tablets over the 28-day Treatment Period (Days 1 to 28) compared to the 28-day Pretreatment Period (Day -28 to Day -1).
Measured: 28 Days
Injection group
Improvement in Symptoms: Number of subjective symptom-free days due to DED or asthenopia over the 28-day Treatment Period (Days 1 to 28), following a single injection compared to the Pretreatment Period (Day -28 to Day -1).
Measured: 28 Days
Secondary outcomes (1)
All Treatment Groups
Change from baseline in visual analog scale (VAS) scores related to eye discomfort to EoS. A decrease in VAS scores while under the treatment will show the efficacy of the treatment.
Measured: 28 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start10 May 2023
- Primary completion9 Nov 2023
- Study completion9 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 103 participants (actual)
- Target duration
- 56 Days
Sponsor and investigators
- Lead sponsor
- Nvision Laser Eye Centers
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Eric Ahn, Principal investigator, Employee for the Platform
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895500
- Sponsor's protocol ID
- PPM_IIS_101
- Status last verified
- May 2024
- First submitted
- 19 May 2023
- Last updated
- 3 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigator-Initiated Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of CGRP Antagonists in Patients With Dry Eye Disease and Asthenopia
- ClinicalTrials.gov ID
- NCT05895500
- Acronym / sponsor ID
- PPM_IIS_101
- Conditions
- Dry Eye, Asthenopia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Nvision Laser Eye CentersIndustry (pharma, biotech, devices)
- Study start
- 10 May 2023 (actual)
- Primary completion
- 9 Nov 2023 (actual)
- Study completion
- 9 Nov 2023 (actual)
- First posted
- 8 Jun 2023 (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.
Safety and Efficacy of Medications for Migraine in Patients with Dry Eye Disease or Asthenopia
Detailed description
An Investigator-Initiated Phase 2a, Open-Label Study to Evaluate the Safety and Efficacy of Medications for Migraine in Patients with Dry Eye Disease or Asthenopia
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 56 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tablet | – | Drug: Tablet (50mg/tablet), oralTablets (50mg/tablet), oral |
| Injection | – | Drug: Injection for SC administration (120mg/syringe)Injection for SC administration (120mg/syringe) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be selected from the clinical database that have previous symptoms and/or chief complaints of dry eye syndrome and asthenopia.
Key inclusion criteria (10 listed)
- Able to understand the key components of the study as described in the written ICF, and willing and able to provide written informed consent.
- Male or female ≥ 18 years of age.
- Clinical diagnosis of:
- Willing and able to comply with the study requirements including prohibited concomitant medication restrictions.
- Agree not to participate in another interventional study while on treatment.
Key exclusion criteria (17 listed)
- Active ocular infection or ocular inflammatory disease other than dry eye disease
- Presence of anterior membrane dystrophy or history of clinically significant recurrent erosion syndrome.
- Significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
- Prior radial keratotomy at any time or prior laser refractive surgery within the past 12 months of Screening Visit.
- Unable to discontinue any over the counter (OTC), herbal, or systemic administration (including transdermal applications) of opioids or treatments for neuropathic pain (e.g., gabapentin or pregabalin, tetrahydrocannabinol) during the study on Days -28 to +28.
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 |
|---|---|---|
| Injection for SC administration (120mg/syringe)Injection | Drug | Injection |
| Tablet (50mg/tablet), oralTablet | Drug | Tablet |
Primary outcome
Tablet group
Time frame: 28 Days
Improvement in Symptoms: Number of days that a participant feels improvement in subjective symptoms of eye discomfort due to DED or asthenopia after oral administration of tablets over the 28-day Treatment Period (Days 1 to 28) compared to the 28-day Pretreatment Period (Day -28 to Day -1).
Injection group
Time frame: 28 Days
Improvement in Symptoms: Number of subjective symptom-free days due to DED or asthenopia over the 28-day Treatment Period (Days 1 to 28), following a single injection compared to the Pretreatment Period (Day -28 to Day -1).
1 secondary outcome
All Treatment Groups
Time frame: 28 Days
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 3 Jun 2024.
- 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.
Eric Ahn principal investigator
Employee for the Platform
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 and Asthenopia, run by Nvision Laser Eye Centers 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 10 inclusion and 17 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 3 Jun 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 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?
Tablet group (time frame: 28 Days). The study lists 2 primary outcomes in all. 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 3 Jun 2024.