Recruiting
Phase 3

Cyclosporine & Intense Pulsed Light

Sponsor:

Université de Sherbrooke

Code:

NCT06392438

Conditions

Dry Eye

Contact Lens Complication

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CycloSPORINE Ophthalmic

Intense Pulsed Light

Sham Intense Pulse Light

Study Details

Brief summary:

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.

Conditions

Dry Eye

Contact Lens Complication

Study ID

NCT06392438

Start date

Apr 25, 2024

Status verified date

Apr, 2024

Completion date

Sep, 2025

Anticipated

Primary completion date

Sep, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Soft silicone-hydrogel contact lens wearers
  • Monthly, 2-weeks, opr daily replacement schedule of contact lens
  • Minimum wear of contact lens for 1 day/week and 4 hours consecutive
  • f-CLDEQ-8 score ≥ 12

Exclusion Criteria:

  • Past usage of cyclosporine 0.09% (Cequa)
  • Use of another ophthalmic cyclosporine drop in the past 6 months
  • Known intolerance to cyclosporine
  • Pregnancy or breastfeeding (or planned pregnancy in the duration study)
  • History of ocular herpes simplex infection
  • Active ocular infectious condition
  • Usage of photosensitizing medication
  • Epilepsy
  • History of skin cancer in the IPL treatment zone
  • Tattoo/pigmented lesion/keloid scars in the IPL treatment zone
  • Refractive surgery in the past 12 months
  • In-clinic thermal pulsation eyelid treatment in the past 12 months
  • Usage of glaucoma drops
  • Regular continuous wear of contact lenses (including sleep)
  • Excessive movement or decentration of the contact lenses (assessed at first visit)
  • Giant papillary conjunctivitis

Study Design

Enrollment

44 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IPL group

Participants will receive 0.09% cyclosporine drops dosed at bid for 16 weeks. Participants receive 3 IPL sessions at 3-weeks interval in the last 2 months of the study. IPL treatments will be given with Lumenis M22 with a 590nm filter, pulse duration of 6-50ms (3 pulses/trigger) and fluence will be determined after determining the skin type (Fitzpatrick scale) of the participant.

sham comparator: Sham-IPL group

Participants will receive 0.09% cyclosporine drops dosed at bid for 16 weeks. Participants receive 3 IPL sessions at 3-weeks interval in the last 2 months of the study. IPL treatments will be given with Lumenis M22 with a 590nm filter, pulse duration of 6-50ms (3 pulses/trigger) and fluence will be determined set at 10 J/cm2. A plastic filter will recover the IPL prism, preventing the light to reach the skin of the participant.

Interventions

CycloSPORINE Ophthalmic

Unidose of Cequa provided without charge to the participant. 1 drop in each eye morning and evening.

Intense Pulsed Light

Appropriate eye patches and IPL gel will be applied. 15 triggers per passage will be applied from the right temple to the left temple (7 shots from the right temple to the right nose wing, 1 on the nose bridge and 7 shots from the left nose wing to the left temple). 2 passage/session will be applied.

Sham Intense Pulse Light

Appropriate eye patches and IPL gel will be applied. 15 triggers per passage will be applied with the plastic blocker mounted on the IPL prism from the right temple to the left temple (7 shots from the right temple to the right nose wing, 1 on the nose bridge and 7 shots from the left nose wing to the left temple). 2 passage/session will be applied.

Primary outcome measure

  • Contact lens dry eye symptoms [ Time Frame: Measured at each visit (Baseline, week 8, week 11, week 14 and week 16) ]

Central Contacts and Locations

Central contacts

Patrick Boissy, PhD

819-780-2220patrick.boissy@usherbrooke.ca

Eric Lortie-Milner, OD, FAAO

514-773-1113eric.lortie-milner@usherbrooke.ca

Locations

Opto-Réseau Sherbrooke Est

Recruiting

Sherbrooke, Quebec, Canada, J1E 2T1

Contacts

Jean-Yves Roy, OD, FAAO

819-564-2325o.sherbrookeest@cliniqueopto.com

Principal Investigator:

Patrick Boissy, PhD

More Information

Sponsor

Université de Sherbrooke

Last update posted

May 1, 2024

Last verified

Apr, 2024

Keywords

  • Contact Lens Discomfort
  • Intense Pulsed Light
  • Cyclosporine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Université de Sherbrooke on 2024-05-01.