44 Participants Needed

Cyclosporine + Intense Pulsed Light for Dry Eye Syndrome

(CycliP Trial)

PB
EL
Overseen ByEric Lortie-Milner, OD, FAAO
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Université de Sherbrooke
Must be taking: Cyclosporine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

In this study, two treatments typically used for dry eye disease will be tried for contact lens users to see if their symptoms when they use their contact lenses get better. Cyclosporine is a drop that is used for long-term management of the inflammation and Intense pulsed light (IPL) is a treatment done in a clinic to improve the health of the eyelid glands. The main question in this study is:Does the combined treatment of cyclosporine and IPL improve the symptoms and the dry eye signs of contact lens wearers?All the participants will receive the cyclosporine drops for 4 months twice a day. The research team will split the group of participants in two, half receiving the real IPL treatment and half receiving a sham IPL treatment during the last two months of the study. This will allow to compare the two groups to see how IPL helped. The dry eye tests will be done at the start of the study, after two months and after 4 months. The tests will include a dry eye symptoms questionnaire, measures on the tears, the structures of the front of the eye and the eyelids.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used cyclosporine eye drops recently or are using photosensitizing medication.

Is the combination of Cyclosporine and Intense Pulsed Light safe for treating dry eye syndrome?

Research on cyclosporine for dry eye disease shows it is generally safe, with common side effects like burning or stinging in the eyes. However, there is no specific safety data available for the combination of cyclosporine and intense pulsed light.12345

How is the drug cyclosporine unique in treating dry eye syndrome?

Cyclosporine is unique because it is an anti-inflammatory drug that specifically targets the immune system to reduce inflammation on the eye's surface, making it effective for dry eye syndrome and other immune-related eye conditions. It is available as a topical emulsion, which is a non-toxic alternative to other potentially harmful treatments.12467

What data supports the effectiveness of the treatment Cyclosporine + Intense Pulsed Light for Dry Eye Syndrome?

Research shows that cyclosporine 0.05% has been effective in treating dry eye disease and other eye conditions with an immune-based inflammatory component. It has been approved by the FDA for dry eye disease and has shown positive results in managing conditions like ocular rosacea and post-LASIK dry eye.23678

Who Is on the Research Team?

PB

Patrick Boissy, PhD

Principal Investigator

Professor University of Sherbrooke

LM

Langis Michaud, OD, MSc

Principal Investigator

Professor University of Montreal

EL

Eric Lortie-Milner, OD

Principal Investigator

PhD candidate University of Sherbrooke

Are You a Good Fit for This Trial?

This trial is for contact lens users who suffer from dry eye syndrome. Participants should be willing to use cyclosporine drops twice daily and undergo IPL treatments. Those with certain eye conditions or who have had recent eye surgery may not qualify.

Inclusion Criteria

Soft silicone-hydrogel contact lens wearers
f-CLDEQ-8 score ≥ 12
I change my contact lenses daily, every 2 weeks, or monthly.
See 1 more

Exclusion Criteria

Known intolerance to cyclosporine
I currently have an eye infection.
Excessive movement or decentration of the contact lenses (assessed at first visit)
See 13 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 0.09% cyclosporine drops twice a day for 16 weeks. In the last 2 months, participants receive either real or sham IPL treatment.

16 weeks
5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cyclosporine
  • Intense Pulsed Light
  • Sham Intense Pulse Light
Trial Overview The study tests if using cyclosporine eye drops in combination with Intense Pulsed Light (IPL) therapy can improve dry eyes in contact lens wearers, compared to those only using the drops and receiving a sham IPL treatment.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: IPL groupExperimental Treatment2 Interventions
Group II: Sham-IPL groupPlacebo Group2 Interventions

Cyclosporine is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺
Approved in European Union as Neoral for:
🇺🇸
Approved in United States as Neoral for:
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Approved in Canada as Neoral for:
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Approved in Japan as Neoral for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials
317
Recruited
79,300+

Published Research Related to This Trial

In a study of 25 long-term contact lens wearers with dry eye syndrome, cyclosporine emulsion 0.05% significantly improved tear film stability and basal tear secretion over 6 months, with increases of 37.3% and 82.4%, respectively.
The treatment also enhanced contact lens tolerance and restored corneal epithelial structure, indicating that cyclosporine emulsion can effectively address symptoms of dry eye in patients unresponsive to conventional therapies.
[Topical cyclosporine for the treatment of ocular surface changes in contact lens wearers].Egorova, GB., Mitichkina, TS., Fedorov, AA., et al.[2018]
Cyclosporine 0.05% ophthalmic emulsion, approved by the FDA in 2003, is effective in treating dry eye disease and has shown efficacy in managing various ocular surface disorders with an immune-based inflammatory component.
This topical formulation serves as a safe and non-toxic alternative to other potentially harmful immunosuppressive therapies, making it a valuable option for patients with conditions like posterior blepharitis and ocular rosacea.
Topical ophthalmic cyclosporine: pharmacology and clinical uses.Donnenfeld, E., Pflugfelder, SC.[2022]
Topical cyclosporine 0.05% (Restasis) significantly improved dry eye symptoms in 7 out of 8 patients with graft versus host disease after stem cell transplantation, indicating its efficacy for this specific condition.
The treatment led to statistically significant improvements in key measures of dry eye, including tear production and stability, as evidenced by Schirmer scores, tear breakup time, and tear lysozyme levels, suggesting a beneficial mechanism of action.
Efficacy of topical cyclosporine 0.05% in the treatment of dry eye associated with graft versus host disease.Rao, SN., Rao, RD.[2015]

Citations

1.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Topical cyclosporine for the treatment of ocular surface changes in contact lens wearers]. [2018]
Topical ophthalmic cyclosporine: pharmacology and clinical uses. [2022]
Efficacy of topical cyclosporine 0.05% in the treatment of dry eye associated with graft versus host disease. [2015]
Comparison of Subjective Responses to Cyclosporine 0.05% Versus Lifitegrast 5.0% in Individuals With Dry Eye Disease. [2023]
Phase III safety evaluation of cyclosporine 0.1% ophthalmic emulsion administered twice daily to dry eye disease patients for up to 3 years. [2022]
Physician Satisfaction with Anti-Inflammatory Topical Medications for the Treatment of Dry Eye Disease. [2022]
Cyclosporine A (0.05%) Ophthalmic Gel in the Treatment of Dry Eye Disease: A Multicenter, Randomized, Double-Masked, Phase III, COSMO Trial. [2022]
Efficacy of topical ophthalmic drugs in the treatment of dry eye disease: A systematic literature review. [2020]
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