Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users

NCT06392438 | Recruiting Phase 3 DMC

• 1 other identifier: 2024-5200
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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

Keywords

Contact Lens Discomfort; Intense Pulsed Light; Cyclosporine

Outcome Measures

Primary Outcomes (1)

• Contact lens dry eye symptoms

  f-CLDEQ-8 questionnaire (French version of the Contact Lens Dry Eye Questionnaire - 8). Scores possible are from 1 to 37; higher score means more symptoms and worse dry eye

  Measured at each visit (Baseline, week 8, week 11, week 14 and week 16)

Secondary Outcomes (14)

• Global rating scale of change

  Tuesday and Saturday of every week for 16 consecutive weeks (while participating in the study)

• Average number of hours spent wearing contact lenses

  Tuesday and Saturday of every week for 16 consecutive weeks (while participating in the study))

• Artificial tear usage while wearing contact lenses

  Tuesday and Saturday of every week for 16 consecutive weeks (while participating in the study)

• Non-invasive tear break-up time over contact lenses (pre-lens tear film)

  Baseline, week 8, and week 16

• Non-invasive tear break-up time (natural tear film)

  Baseline, week 8, and week 16

Study Arms (2)

IPL group

EXPERIMENTAL

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.

Drug: CycloSPORINE Ophthalmic; Procedure: Intense Pulsed Light

Sham-IPL group

SHAM COMPARATOR

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.

Drug: CycloSPORINE Ophthalmic; Procedure: Sham Intense Pulse Light

Interventions

CycloSPORINE Ophthalmic DRUG

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

Also known as: Cequa

IPL group; Sham-IPL group

Intense Pulsed Light PROCEDURE

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.

Also known as: IPL M22 Lumenis

IPL group

Sham Intense Pulse Light PROCEDURE

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.

Also known as: Sham-IPL M22 Lumenis

Sham-IPL group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Opto-Réseau Sherbrooke Est

Sherbrooke, Quebec, J1E 2T1, Canada

RECRUITING

Related Publications (62)

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MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Cyclosporins; Intense Pulsed Light Therapy

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins; Phototherapy; Therapeutics

Study Officials

• Patrick Boissy, PhD

  Professor University of Sherbrooke

  STUDY CHAIR

• Langis Michaud, OD, MSc

  Professor University of Montreal

  STUDY DIRECTOR

• Eric Lortie-Milner, OD

  PhD candidate University of Sherbrooke

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patrick Boissy, PhD

CONTACT

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

Eric Lortie-Milner, OD, FAAO

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will be unaware of their allocation in either the experimental group (IPL) or the control group (sham-IPL). Due to the nature of the treatment, it was not possible to mask the researcher that is performing the IPL treatment. Meibography score and conjunctival staining (requiring clinical judgment) will be analyzed by assessors that are masked (from images captured by a non-masked investigator).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This study is a randomized, sham controlled clinical trial. It consists of two treatments, one of which is applied to all the participants (cyclosporine). and the second one, for which participants are randomized in either the IPL group (experimental) or the IPL-sham group (control). Data collection is a pre-post model, with data being collected at baseline, during the trial (mid-study) and after the treatments. Data analysis is in intent-to-treat.

Study Record Dates

• First Submitted: April 23, 2024
• First Posted: April 30, 2024
• Study Start: April 25, 2024
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Any time after publication of the results from this trial
• Access Criteria: Verified scholar; clearly stated motive and need for the data; plan to securely store the data.

Locations

CA (1)