Dry Eye Disease (DED)
Conditions
Brief summary
This goal of this clinical trial is to compare the effects of two approved cyclosporine eye drops that have different concentrations and vehicles on the number of mucus producing conjunctival goblet cells in patients with dry eye disease to learn which one causes the greatest increase. The main questions it aims to answer are: Does one drug cause a greater increase in goblet cells? How many weeks does it take to see the difference? Participants will: Use the eye drops every day for 2 months Visit the clinic once every 2 weeks for exams and tests
Detailed description
Sixty participants with dry eye will be randomized to receive either cyclosporine 0.1% dissolved in perfluorobutylpentane (Vevye®) or 0.05% cyclosporine emulsion (generic Restasis®) to instill in their eyes twice a day for 60 days. The number of mucus producing goblet cells will be measured in the conjunctiva in both eyes by impression cytology. The percentage change in goblet cell number from baseline (before treatment ) at day 60 is the primary endpoint. Treatment groups will also be compared at days 14 and 30.
Interventions
DRUGVevye®
cyclosporine 0.1% in perfluoroalkane vehicle
DRUGCyclosporine emulsion
cyclosporine 0.05% emulsion
Sponsors
Baylor College of Medicine
Harrow Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Laboratory perfoming goblet cell analysis
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 1\. Male or female, 18 years of age or older at enrollment. 2. Have a history of DED, clinician diagnosed or patient reported, within the 6 months prior to the enrollment visit. 3\. Have both of these signs of DED in the same eye at the Enrollment (baseline) visit: 1. Total cornea fluorescein staining score ≥ 3 based on the modified National Eye Institute (NEI) grading scheme. 2. Total conjunctival lissamine green staining score ≥ 2 based on the modified NEI grading scheme. 4. Unanesthetized Schirmer test score ≥ 5 and \< 15mm/5 min in at least 1 eye at the enrollment visit. 5\. A SANDE eye discomfort visual analog questionnaire score of ≥ 35 at the enrollment visit. 6\. Good general and ocular health, as determined by the investigator using medical history and ophthalmic examination. 7\. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 8\. Have given written informed consent prior to any study related procedures. 9. Able and willing to follow study instructions and likely to complete all required study visits as assessed by the investigator.
Exclusion criteria
* Inclusion Criteria: To be eligible to participate in this trial, an individual must meet all the following criteria: 1. Male or female, 18 years of age or older at enrollment. 2. Have a history of DED, clinician diagnosed or patient reported, within the 6 months prior to the enrollment visit. 3. Have both of these signs of DED in the same eye at the Enrollment (baseline) visit: 1. Total cornea fluorescein staining score ≥ 3 based on the modified National Eye Institute (NEI) grading scheme. 2. Total conjunctival lissamine green staining score ≥ 2 based on the modified NEI grading scheme. 4. Unanesthetized Schirmer test score ≥ 5 and \< 15mm/5 min in at least 1 eye at the enrollment visit. 5. A SANDE eye discomfort visual analog questionnaire score of ≥ 35 at the enrollment visit. 6. Good general and ocular health, as determined by the investigator using medical history and ophthalmic examination. 7. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 8. Have given written informed consent prior to any study related procedures. 9. Able and willing to follow study instructions and likely to complete all required study visits as assessed by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Outcome | 60 days | Percentage change from baseline in goblet cell density at Day 60 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome 1 | 60 days | Change from baseline in goblet cell density at Day 60 |
| Secondary Outcome 2 | 60 days | Proportion of subjects with an increase in areas covered by goblet cells at Day 60 |
| Secondary Outcome 3 | 60 days | Proportion of subjects with increase in mean goblet cell density at Day 60 |
| Secondary Outcome 4 | Days 14 and 30 | Change from baseline in goblet cell density at Days 14 and 30 |
Contacts
CONTACTStephen C Pflugfelder, M.D.
CONTACTJenna Davis, B.S.
PRINCIPAL_INVESTIGATORStephen C Pflugfelder, M.D.
Baylor College of Medicine
Outcome results
None listed