Clinical Trial Opportunities

Laura M. Periman, MD

To be considered for a Clinical Trial involves a well defined process.  Periman Eye Institute and our research staff will walk you through the process and what it would mean to participate.

Whether you are a patient looking to get involved in a clinical trial or a physician with a potential candidate interested in any of our current studies actively recruiting patients, please use our Clinical Trials Inquiry form if you:

  • Need answers to any study-related questions
  • Are a patient and interested in enrolling in a study or
  • Are a physician interested in referring a patient you believe may qualify.

Below is a list of our current clinical trials actively recruiting patients. Select a study title to read detailed information about each study.

Clinical Trial Opportunities

iLUXiTEARDupilumabComet 4

For: Patients with MGD who wear soft contact lenses.

Study Link:

https://clinicaltrials.gov/ct2/show/NCT05306561?term=pei-iit-70111343&draw=2&rank=1

  1. Eligible subjects must be 18 years of age or older
  2. Eligible subjects must be willing and able to provide an English language written Informed Consent Form
  3. Be a current soft contact lens wearer for at least 2-18 hours a day 4-7 days a week but experiencing contact lens discomfort that limits the number of hours of comfortable contact lens wear.
  4. Have worn the same commercially available soft contact lens (material, base curve, diameter) for the previous 90 days
  5. Have new contact lens to wear starting the first day after iLux treatment
  6. Have an OSDI score greater than ≥ 12
  7. Have a CLDEQ8 score ≥ 12
  8. Have a minimum meibomian gland expression score ≤ 12 (using MGD scoring system: apply pressure with korb expressor to 15 glands of lower lid (5 nasal, 5 central, 5 temporal): each gland will be scored from 0 to 3 (0 = no secretion, 1 = inspissated, 2 = cloudy, 3 = clear liquid), sum of score from each gland with equal total score, total score will range from 0-45.
  9. Be able and willing to follow instructions and participate in all trial assessments and visits
  10. Eligible subjects must be fully vaccinated against COVID-19
  1. Have any clinically significant slit-lamp findings at Visit 1 that in the opinion of the investigator may interfere with trial parameters
  2. Have abnormal lid anatomy eg. entropion, ectropion or active lid lesion eg. hordeolum, chalazion that may interfere with administering iLux treatment
  3. Had Lipiflow, iLux, Tear Care or manual meibomian gland expression in the last 30 days
  4. Be a woman who is pregnant, nursing, or planning a pregnancy
  5. Had ocular surgery within the last 90 days
  6. Have used topical cyclosporine, lifitegrast, topical or facial steroids, serum tears, or oral doxycycline or tetracycline within the last 30 days before Visit 1
  7. Had Intense Pulsed Light (IPL) treatment within last 30 days
  8. Have active ocular infection or inflammation
  9. Be a current wearer of extended wear contact lenses

For: Patients with Dry Eye Disease

Study Link:

https://clinicaltrials.gov/ct2/show/NCT05304637?term=clp-011&draw=2&rank=1

  1. Dry eye
  1. Unable to read consent
  2. Investigator discretion

Patients with Atopic Keratoconjunctivitis

Evaluation of Dupilumab in Patients with AKC

Study Link:

https://clinicaltrials.gov/ct2/show/NCT04296864?term=18-290-0002&draw=2&rank=1

  • be at least 18 years of age at Visit 1 of either gender and any race or ethnicity;
  • provide written informed consent and sign the HIPAA form;
  • be willing and able to follow all instructions and attend all study visits;
  • if on an active therapy for AKC prior to Visit 1, such treatment must have been maintained stably for at least 2 weeks for topical corticosteroids, topical and oral antihistamines, topical mast cell stabilizers, and topical tacrolimus and at least 3 months for topical and oral cyclosporine, and systemic corticosteroids. Such therapy must remain current throughout duration of study;
  • have a history of AKC or atopic dermatitis with a diagnosis of AKC at Visit 1 (by meeting inclusion 7 and 8);
  • be able to self-administer or receive subcutaneous injections satisfactorily or have a caregiver at home routinely available for this purpose. If unable to administer at home, patients must be willing to come in to office to receive injections that do not coincide with a visit;
  • present signs of active disease, defined as one or more of the following in at least one eye at Visit 2 (baseline):
    • >/=2 score in conjunctival redness AND
    • >/=2 score in at least one of the following lid disease signs: i. lid margin redness ii. lid excoriation
  • present symptoms of active disease, defined as having both of the following in at least one eye at Visit 2 (baseline):
    • >/=2.5 score in ocular itching AND
    • >/=2 score for ocular discomfort;
  • (for females capable of becoming pregnant) agree to have urine pregnancy testing performed at screening (must be negative) and at exit visit; must not be lactating; and must agree to use at least one medically acceptable form of birth control throughout the study duration and for at least 14 days prior to the first dose of investigational product (Visit 2) and for 1 month after the last dose of investigational product. Note: Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
  • have a calculated visual acuity of 0.7 logarithm of the minimum angle of resolution (logMAR) or better in at least one eye (Snellen equivalent of 20/100) and 1.0 logMAR (or count fingers) or better in the fellow eye (Snellen equivalent of 20/200) as measured using an Early Treatment for Diabetic Retinopathy Study (ETDRS) chart.
  • have known contraindications or sensitivity to the use of any of the study drug(s) or their components, or any other medications required by the protocol;
  • wear contact lenses for at least 48 hours prior to and during the study trial period;
  • have a corneal ulcer in either eye;
  • have a presence or history of ocular herpes or varicella-zoster infections in either eye;
  • have uncontrolled ocular hypertension or glaucoma in either eye;
  • have prior (within 30 days of beginning investigational product) or anticipated concurrent use of an investigational product or device during the study period;
  • have an ocular or systemic condition or a situation which, in the investigator’s opinion, may put the patient at increased risk, confound study data, or interfere significantly with the patient’s study participation;
  • manifest in either eye symblepharon, significant conjunctival scarring, and/or fornix shortening;
  • have planned surgery (ocular or systemic) during the trial period or within 30 days after the study period;
  • have an abnormal blood pressure (defined as ≤ 90 or ≥ 160 (systolic) measured in mmHg or ≤ 60 or ≥ 100 (diastolic) measured in mmHg) at Visit
  • be a female who is currently pregnant, planning a pregnancy, or lactating;
  • have any previous exposure to dupilumab (unless discontinuation of exposure was due to a non-medical reason);
  • have treatment with a live (attenuated) vaccine during the study;
  • have an untreated parasitic (helminth) infection prior to Visit 2 and during the study.

For: Patients with Dry Eye Disease not currently treating

Study Link:

https://clinicaltrials.gov/ct2/show/NCT05285644?term=comet&cond=dry+eye&draw=2&rank=2

  • Male or female, 30 years of age or older at the Screening visit
  • Signs of DED at the Screening and Baseline visits assessed by corneal staining and Schirmer test
  • Symptoms of DED at both Screening and Baseline visits assessed by SANDE questionnaire and ODS-VAS
  • Corrected visual acuity (+0.70 LogMAR) or better in both eyes at both the Screening and Baseline visits
  • History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety
  • Regular use of lid hygiene within 14 days prior to the Screening visit or any planned use during the study
  • Use of artificial tears within 2 hours prior to the Screening visit or anticipated use during the study
  • Use of any topical ocular anti-inflammatory medication within 30 days prior to the Screening visit or anticipated use during the study (e.g., ocular cyclosporine [Restasis®, Cequa™], lifitegrast [Xiidra®], or any other prescription ophthalmic solution for DED, topical ocular corticosteroid- or non-steroidal-anti-inflammatory agents
  • Use of Tyrvaya™ (varenicline solution, nasal spray 0.03mg) within 30 days prior to the Screening visit or anticipated use during the study
  • Use of medications for the treatment of severe DED and/or Meibomian gland disease such as oral tetracyclines, oral tetracycline derivatives and oral retinoids within 30 days prior to the Screening visit or anticipated use during the study
  • Initiation, discontinuation, or change in dose of a systemic medication known to cause ocular drying (e.g. antihistamines or tricyclic antidepressants) less than 14 days prior to the Screening visit or a change in dosage is anticipated during the study.
  • Initiation, discontinuation, or change in dose of a systemic corticosteroid less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study.
  • Initiation, discontinuation, or change in dose of a systemic immunomodulator (e.g., hydroxychloroquine, methotrexate, cyclosporine) less than 60 days prior to the Screening visit or a change in dosage is anticipated during the study
  • History or presence of significant systemic disease (i.e.: cardiovascular, pulmonary, hepatic, renal, hematologic, immunologic)