Dry Eye Disease study: Cyclosporine
Official title Treating Contact Lens Discomfort With Cyclosporine 0.1% Ophthalmic Solution
ClinicalTrials.gov ID: NCT07904728
What this study is testing
What is Cyclosporine 0.1% Ophthalmic Solution?
Cyclosporine 0.1% Ophthalmic Solution is an investigational medicine, being studied as a potential treatment for dry eye disease (ded).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Of the 140 million contact lens (CL) wearers worldwide, most wear soft contact lenses. Despite major improvements in contact lens care, nearly 20% of wearers stop using lenses, with contact lens discomfort (CLD) being the main reason.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adult male and female people of any race or ethnicity who are ≥18 years of age.
- Best corrected CL visual acuity of 0.3 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes (Snellen equivalent 20/40).
- Daily, soft, frequent replacement CL wearer (daily disposable, bi-weekly, or monthly CLs).
- Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores (CLDEQ-8 scores ≥ 12).
- A VAS score of ≥40 for Eye Dryness and End of Day Contact Lens Discomfort.
You likely can't join if
- Any history of VEVYE use within 6 months of enrollment.
- Are currently an overnight CL wearer.
- Are currently wearing rigid gas permeable CLs, scleral CL, hybrid CLs, or custom soft CLs.
- Have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- Have a history of ocular surgery within the past 12 months.
- Have a history of viral eye disease.
See the full eligibility criteria
- Adult male and female people of any race or ethnicity who are ≥18 years of age.
- Best corrected CL visual acuity of 0.3 Logarithm of the Minimum Angle of Resolution (logMAR) or better in both eyes (Snellen equivalent 20/40).
- Daily, soft, frequent replacement CL wearer (daily disposable, bi-weekly, or monthly CLs).
- Contact Lens Dry Eye Questionnaire (CLDEQ)-8 scores (CLDEQ-8 scores ≥ 12).
- A VAS score of ≥40 for Eye Dryness and End of Day Contact Lens Discomfort.
- A corneal fluorescein staining score on the original NEI scale of ≥3.
- Habitually wears soft CLs for a minimum of 5 days per week for 6 hours per day during the month prior to enrollment.
- Willing to maintain habitual CL wear routine for the 3 months duration of the study.20
- Willing to only use VEVYE for dry eye treatment for the 3 months duration of the study.
- Willing to use VEVYE twice a day even if CL is not worn for that day.
- Habitual CLs have an acceptable fit (good centration, movement, and coverage).20
- Willing to not use any lipid containing artificial tear (AT) for the 3 months duration of the study.
- Willing to only use non-lipid containing preservative free artificial tear for the 3 months duration of the study if needed, but no more than 4 times per day
- Willing to record daily time for CL application, removal, and VEVYE applications.
- Any history of VEVYE use within 6 months of enrollment.
- Are currently an overnight CL wearer.
- Are currently wearing rigid gas permeable CLs, scleral CL, hybrid CLs, or custom soft CLs.
- Have known systemic health conditions that are known to alter tear film physiology (e.g., primary and secondary Sjögren's syndrome).
- Have a history of ocular surgery within the past 12 months.
- Have a history of viral eye disease.
- Have a history of severe ocular trauma, active ocular infection or inflammation.
- Have ever used or are currently using isotretinoin-derivates (e.g., Accutane).
- Are currently taking ocular medications or plan to during the study (e.g., DED, glaucoma, etc.).
- Are currently taking systemic medications that have anticholinergic properties (e.g., antihistamines, antianxiety, antidepressants, etc.) and use is anticipated to change during the course of the study (anticipated...
- people with meibomian gland blockage or significant atrophy (e.g., severe MGD). Currently having \>50% blockage of Meibomian glands in more than two eyelids.
- Having blepharitis and/or demodex blepharitis \> grade 2.
- Have had a physical meibomian gland dysfunction treatment within 3 month of enrollment (iLux, Lipiflow, Radio Frequency and IPL with manual expressions, microblepharoexfoliation etc.).
- Have used a prescription DED or ocular surface disease medication in the last 1 month.
- Have used Lacrifill withing 1 month of enrollment.
- Have a condition or in a situation, which in the examiner's opinion, may put the subject at significant risk, may confound the study results, or may significantly interfere with their participation.
- Are pregnant or breast feeding or plan to get pregnant. Note: To participate in this study, people of child bearing potential must be on an adequate form of birth control, which can include but not limited to: Barrier...
The study team makes the final eligibility decision.
Where it is enrolling
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Houston, Texas, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.