Cyclosporine and Intense Pulsed Light for Dry Eye in Contact Lens Users
NCT ID: NCT06392438
Last Updated: 2024-05-01
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
Recruitment Status
RECRUITING
Clinical Phase
PHASE3
Total Enrollment
44 participants
Study Classification
INTERVENTIONAL
Study Start Date
2024-04-25
Study Completion Date
2025-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Intense Pulsed Light for Improving Dry Eye Syndrome
NCT03396913
Dry Eye Syndrome
COMPLETED
NA
Efficacy of Topical Cyclosporine 0.05% in the Prevention of Ocular Surface Inflammation Secondary to Pterygia
NCT00383396
Pterygia
COMPLETED
PHASE4
Cyclosporine 0.1% / Loteprednol 0.2% Effect on Anterior Segment Normalization
NCT05322148
Dry Eye
COMPLETED
PHASE3
Study of Cyclosporine Ophthalmic Soution Group and Cyclosporine Ophthalmic Suspension Group
NCT01768312
Dry Eye Syndromes
COMPLETED
PHASE3
Efficacy of Optive Versus Systane Concomitant With Restasis (Cyclosporine A) for the Treatment of Dry Eye Symptoms
NCT00399061
Dry Eye
COMPLETED
PHASE4
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Dry eye disease is a complex and multifactorial pathology in which inflammation and changes to the tear film (instability and hyperosmolarity) play important roles. Dry eye disease is very common, with an estimated global prevalence of 11.59% although other analyses conclude to 50% of some populations suffering from dry eye. The condition has been traditionally classified in two subtypes: aqueous tear deficiency (secondary to a deficit of production by the lacrimal gland) and evaporative disease (secondary to a deficit of the lipid layer of the tear film), but when the condition progresses, almost all patients present characteristics of both subtypes. Meibomian gland dysfunction (MGD) is one of the conditions that is most frequently associated with dry eye disease and leads to evaporative dry eye and alterations of the ocular surface. The prevalence of MGD has been recently established between 21.2% and 29.5% in subjects of African and Caucasian race and higher among Arabs, Hispanics, and Asians. Many risk factors exist for dry eye disease and MGD, including age and usage of contact lens. Soft contact lenses (SCL) are used by hundreds of millions for visual correction. The wear of SCL, however, has the potential to create or worsen dry eye signs and symptoms. A comparative study has found that 39% of North-American wearers can be categorized as symptomatic of contact lens dry eye and the proportion of uncomfortable users increases with age. SCL wear can increase evaporative dry eye by weakening the lipid layer, which leads to decreased stability of the tear film and increased evaporation. It also contributes to aqueous dry eye etiology by reducing the tear volume. The wear of SCL has also been shown to have a damaging effect on meibomian glands and, in some cases, on the conjunctival goblet cells .
Arguments also support the role of SCL in the inflammation of the ocular surface, even in asymptomatic patients. Thus, dry eye disease associated with SCL wear is a complex condition that implies different mechanisms.
Cyclosporine A is a peptide produced by a fungus that has been used systemically for decades for its potent immunomodulatory effects. Usage for dry eye disease in a topical 0.05% oil-based formulation has been common since the early 2000s. On the ocular surface, cyclosporine acts by inhibiting calcineurin, which subsequently blocks the activation of T cells and prevents the release of cytokines, therefore reducing inflammation. It has been shown to increase tear volume, goblet cell density and to reduce surface staining as well as symptoms in dry eye patients. Divergent results have been observed on contact lens wearers, although one study has found an amplified effect on contact lens wearers symptomatic of dry eye when combining essential fatty acid supplements with topical cyclosporine. Despite having been shown useful in the management of dry eye disease, the oil-based formulation is considered having a low bioavailability. A new cyclosporine eyedrop has been approved in Canada and the USA in the recent past years and is based on nanomicelle technology with a concentration of 0.09%. This nano-micellar formulation could be more effective in delivering the cyclosporine to the tissues and have been shown to reduce ocular surface staining, to increase tear volume, and to be safe. Adverse events that are known to this product are mild, such as transient pain at instillation for about 23% of patients.
Intense pulsed light (IPL) is a therapeutic process that has been used for many years in dermatology and esthetics. The noncoherent pulses of light produce photo-biochemical effects and, in the treatment of dry eye disease, the application on the skin around the orbit to produces these effects on the meibomian glands and their surrounding tissue. The mechanisms by which IPL improves signs and symptoms of dry eye are not fully understood, but the melting of the meibum, the clogging of telangiectatic inflammatory vessels, the reduction of epithelial turnover, the improvement in the collagen synthesis, a mitochondrial activity enhancement (photo modulation), and the destruction of parasitic and bacterial species are the main theoretical explanations. IPL has been shown to be an effective therapeutic option to manage MGD.
Dozens of studies have shown that IPL reduces dry eye symptoms, increases tear break-up time, improves the secreting function of the glands as well as the quality of the meibum and reduces corneal staining. IPL is often combined with meibomian gland expression to maximize the therapeutic effects; however, controlled studies have shown that IPL is largely responsible of these effects and that it is the core mechanism of this combination. Two studies have observed the effect of IPL on SCL users, with the conclusion that it is an effective treatment for this population. IPL is considered to be a safe treatment.
Since SCL have been linked to both aqueous and evaporative etiologies or dry eye, this research project aims to study the effect of combining these two treatments to target the entirety of the tear film, believed to be essential to comfortable SCL wear. This study will be a randomized clinical trial that contains two interventions: the 0.09% cyclosporine eyedrops (Cequa) and IPL treatment. The main objective of this study is to establish if the treatment of contact lens related dry eyes by the combination of 0.09% cyclosporine for 16 weeks and a standard IPL treatment (3 sessions) is more effective in relieving dry eye symptoms when compared to 0.09% cyclosporine for 16 weeks with a sham IPL treatment (3 sessions). The secondary objectives are to compare the effects of each treatment combination (0.09% cyclosporine+IPL vs 0.09% cyclosporine+sham) on signs of dry eye, to explore the effects of cyclosporine 0.09% drops alone on contact lens wearers and to assess the security profile of these interventions on SCL wearers.
Based on prior data from the f-CLDEQ-8 validation study, a major study on the cyclosporine nanomicelle formulation and the first clinical trial on IPL for contact lens wearers, a sample size of 44 participants (22/group) was calculated to be necessary to detect a significant difference between the groups. 44 participants will thus be recruited from a primary care optometric clinic and nearby clinics. Participation to the study will require 5 visits from the participants. The first visit will be a collection of data and the dispensing of the 0.09% cyclosporine drops. 8 weeks later, the participants will present for their 2nd visit, during which data will be collected once again and participants will be randomized to either the treatment or the sham group and will receive their first treatment (IPL or sham accordingly to the assignation). The 2 following visits, 3 weeks apart, will be for the 2 last IPL/sham treatments. A final visit will be for data collection 2 weeks after the last IPL/sham treatment. Participants will take 0.09% cyclosporine for the whole 16 weeks.
A bilateral t-test for independent samples will be used to compare the difference in change on the f-CLDEQ-8 between groups on the 16 weeks interval. Concerning the dry eye signs, statistical treatment will be made to account for inter-eye correlation. Continuous variables will be analyzed using a multi-level model to assess the difference in change between groups on the 16 weeks interval. Discrete variable will be analyzed using a general linear model (GLM) for the same comparison. Data will be handled in an intent-to-treat way.
Arguments also support the role of SCL in the inflammation of the ocular surface, even in asymptomatic patients. Thus, dry eye disease associated with SCL wear is a complex condition that implies different mechanisms.
Cyclosporine A is a peptide produced by a fungus that has been used systemically for decades for its potent immunomodulatory effects. Usage for dry eye disease in a topical 0.05% oil-based formulation has been common since the early 2000s. On the ocular surface, cyclosporine acts by inhibiting calcineurin, which subsequently blocks the activation of T cells and prevents the release of cytokines, therefore reducing inflammation. It has been shown to increase tear volume, goblet cell density and to reduce surface staining as well as symptoms in dry eye patients. Divergent results have been observed on contact lens wearers, although one study has found an amplified effect on contact lens wearers symptomatic of dry eye when combining essential fatty acid supplements with topical cyclosporine. Despite having been shown useful in the management of dry eye disease, the oil-based formulation is considered having a low bioavailability. A new cyclosporine eyedrop has been approved in Canada and the USA in the recent past years and is based on nanomicelle technology with a concentration of 0.09%. This nano-micellar formulation could be more effective in delivering the cyclosporine to the tissues and have been shown to reduce ocular surface staining, to increase tear volume, and to be safe. Adverse events that are known to this product are mild, such as transient pain at instillation for about 23% of patients.
Intense pulsed light (IPL) is a therapeutic process that has been used for many years in dermatology and esthetics. The noncoherent pulses of light produce photo-biochemical effects and, in the treatment of dry eye disease, the application on the skin around the orbit to produces these effects on the meibomian glands and their surrounding tissue. The mechanisms by which IPL improves signs and symptoms of dry eye are not fully understood, but the melting of the meibum, the clogging of telangiectatic inflammatory vessels, the reduction of epithelial turnover, the improvement in the collagen synthesis, a mitochondrial activity enhancement (photo modulation), and the destruction of parasitic and bacterial species are the main theoretical explanations. IPL has been shown to be an effective therapeutic option to manage MGD.
Dozens of studies have shown that IPL reduces dry eye symptoms, increases tear break-up time, improves the secreting function of the glands as well as the quality of the meibum and reduces corneal staining. IPL is often combined with meibomian gland expression to maximize the therapeutic effects; however, controlled studies have shown that IPL is largely responsible of these effects and that it is the core mechanism of this combination. Two studies have observed the effect of IPL on SCL users, with the conclusion that it is an effective treatment for this population. IPL is considered to be a safe treatment.
Since SCL have been linked to both aqueous and evaporative etiologies or dry eye, this research project aims to study the effect of combining these two treatments to target the entirety of the tear film, believed to be essential to comfortable SCL wear. This study will be a randomized clinical trial that contains two interventions: the 0.09% cyclosporine eyedrops (Cequa) and IPL treatment. The main objective of this study is to establish if the treatment of contact lens related dry eyes by the combination of 0.09% cyclosporine for 16 weeks and a standard IPL treatment (3 sessions) is more effective in relieving dry eye symptoms when compared to 0.09% cyclosporine for 16 weeks with a sham IPL treatment (3 sessions). The secondary objectives are to compare the effects of each treatment combination (0.09% cyclosporine+IPL vs 0.09% cyclosporine+sham) on signs of dry eye, to explore the effects of cyclosporine 0.09% drops alone on contact lens wearers and to assess the security profile of these interventions on SCL wearers.
Based on prior data from the f-CLDEQ-8 validation study, a major study on the cyclosporine nanomicelle formulation and the first clinical trial on IPL for contact lens wearers, a sample size of 44 participants (22/group) was calculated to be necessary to detect a significant difference between the groups. 44 participants will thus be recruited from a primary care optometric clinic and nearby clinics. Participation to the study will require 5 visits from the participants. The first visit will be a collection of data and the dispensing of the 0.09% cyclosporine drops. 8 weeks later, the participants will present for their 2nd visit, during which data will be collected once again and participants will be randomized to either the treatment or the sham group and will receive their first treatment (IPL or sham accordingly to the assignation). The 2 following visits, 3 weeks apart, will be for the 2 last IPL/sham treatments. A final visit will be for data collection 2 weeks after the last IPL/sham treatment. Participants will take 0.09% cyclosporine for the whole 16 weeks.
A bilateral t-test for independent samples will be used to compare the difference in change on the f-CLDEQ-8 between groups on the 16 weeks interval. Concerning the dry eye signs, statistical treatment will be made to account for inter-eye correlation. Continuous variables will be analyzed using a multi-level model to assess the difference in change between groups on the 16 weeks interval. Discrete variable will be analyzed using a general linear model (GLM) for the same comparison. Data will be handled in an intent-to-treat way.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Dry Eye
Contact Lens Complication
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Participants
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).
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Group Type
EXPERIMENTAL
CycloSPORINE Ophthalmic
Intervention Type
DRUG
Unidose of Cequa provided without charge to the participant. 1 drop in each eye morning and evening.
Intense Pulsed Light
Intervention Type
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.
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.
Group Type
SHAM_COMPARATOR
CycloSPORINE Ophthalmic
Intervention Type
DRUG
Unidose of Cequa provided without charge to the participant. 1 drop in each eye morning and evening.
Sham Intense Pulse Light
Intervention Type
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
CycloSPORINE Ophthalmic
Unidose of Cequa provided without charge to the participant. 1 drop in each eye morning and evening.
Intervention Type
DRUG
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.
Intervention Type
PROCEDURE
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.
Intervention Type
PROCEDURE
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Cequa
IPL M22 Lumenis
Sham-IPL M22 Lumenis
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are 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
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Université de Sherbrooke
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Patrick Boissy
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Patrick Boissy, PhD
Role: STUDY_CHAIR
Professor University of Sherbrooke
Langis Michaud, OD, MSc
Role: STUDY_DIRECTOR
Professor University of Montreal
Eric Lortie-Milner, OD
Role: PRINCIPAL_INVESTIGATOR
PhD candidate University of Sherbrooke
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Opto-Réseau Sherbrooke Est
Sherbrooke, Quebec, Canada
Site Status
RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Canada
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
Reference Type
BACKGROUND
Papas EB. The global prevalence of dry eye disease: A Bayesian view. Ophthalmic Physiol Opt. 2021 Nov;41(6):1254-1266. doi: 10.1111/opo.12888. Epub 2021 Sep 21.
Reference Type
BACKGROUND
Stapleton F, Alves M, Bunya VY, Jalbert I, Lekhanont K, Malet F, Na KS, Schaumberg D, Uchino M, Vehof J, Viso E, Vitale S, Jones L. TFOS DEWS II Epidemiology Report. Ocul Surf. 2017 Jul;15(3):334-365. doi: 10.1016/j.jtos.2017.05.003. Epub 2017 Jul 20.
Reference Type
BACKGROUND
Rouen PA, White ML. Dry Eye Disease: Prevalence, Assessment, and Management. Home Healthc Now. 2018 Mar/Apr;36(2):74-83. doi: 10.1097/NHH.0000000000000652.
Reference Type
BACKGROUND
Chhadva P, Goldhardt R, Galor A. Meibomian Gland Disease: The Role of Gland Dysfunction in Dry Eye Disease. Ophthalmology. 2017 Nov;124(11S):S20-S26. doi: 10.1016/j.ophtha.2017.05.031.
Reference Type
BACKGROUND
Hassanzadeh S, Varmaghani M, Zarei-Ghanavati S, Heravian Shandiz J, Azimi Khorasani A. Global Prevalence of Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis. Ocul Immunol Inflamm. 2021 Jan 2;29(1):66-75. doi: 10.1080/09273948.2020.1755441. Epub 2020 Jun 26.
Reference Type
BACKGROUND
Schaumberg DA, Nichols JJ, Papas EB, Tong L, Uchino M, Nichols KK. The international workshop on meibomian gland dysfunction: report of the subcommittee on the epidemiology of, and associated risk factors for, MGD. Invest Ophthalmol Vis Sci. 2011 Mar 30;52(4):1994-2005. doi: 10.1167/iovs.10-6997e. Print 2011 Mar. No abstract available.
Reference Type
BACKGROUND
Gomes JAP, Azar DT, Baudouin C, Efron N, Hirayama M, Horwath-Winter J, Kim T, Mehta JS, Messmer EM, Pepose JS, Sangwan VS, Weiner AL, Wilson SE, Wolffsohn JS. TFOS DEWS II iatrogenic report. Ocul Surf. 2017 Jul;15(3):511-538. doi: 10.1016/j.jtos.2017.05.004. Epub 2017 Jul 20.
Reference Type
BACKGROUND
Dumbleton K, Caffery B, Dogru M, Hickson-Curran S, Kern J, Kojima T, Morgan PB, Purslow C, Robertson DM, Nelson JD; members of the TFOS International Workshop on Contact Lens Discomfort. The TFOS International Workshop on Contact Lens Discomfort: report of the subcommittee on epidemiology. Invest Ophthalmol Vis Sci. 2013 Oct 18;54(11):TFOS20-36. doi: 10.1167/iovs.13-13125. No abstract available.
Reference Type
BACKGROUND
Koh S. Contact Lens Wear and Dry Eye: Beyond the Known. Asia Pac J Ophthalmol (Phila). 2020 Dec;9(6):498-504. doi: 10.1097/APO.0000000000000329.
Reference Type
BACKGROUND
Chalmers RL, Young G, Kern J, Napier L, Hunt C. Soft Contact Lens-Related Symptoms in North America and the United Kingdom. Optom Vis Sci. 2016 Aug;93(8):836-47. doi: 10.1097/OPX.0000000000000927.
Reference Type
BACKGROUND
Sulley A, Young G, Hunt C, McCready S, Targett MT, Craven R. Retention Rates in New Contact Lens Wearers. Eye Contact Lens. 2018 Sep;44 Suppl 1:S273-S282. doi: 10.1097/ICL.0000000000000402.
Reference Type
BACKGROUND
Bron AJ, de Paiva CS, Chauhan SK, Bonini S, Gabison EE, Jain S, Knop E, Markoulli M, Ogawa Y, Perez V, Uchino Y, Yokoi N, Zoukhri D, Sullivan DA. TFOS DEWS II pathophysiology report. Ocul Surf. 2017 Jul;15(3):438-510. doi: 10.1016/j.jtos.2017.05.011. Epub 2017 Jul 20.
Reference Type
BACKGROUND
Guillon M, Maissa C. Contact lens wear affects tear film evaporation. Eye Contact Lens. 2008 Nov;34(6):326-30. doi: 10.1097/ICL.0b013e31818c5d00.
Reference Type
BACKGROUND
Nichols JJ, Sinnott LT. Tear film, contact lens, and patient-related factors associated with contact lens-related dry eye. Invest Ophthalmol Vis Sci. 2006 Apr;47(4):1319-28. doi: 10.1167/iovs.05-1392.
Reference Type
BACKGROUND
Alghamdi WM, Markoulli M, Holden BA, Papas EB. Impact of duration of contact lens wear on the structure and function of the meibomian glands. Ophthalmic Physiol Opt. 2016 Mar;36(2):120-31. doi: 10.1111/opo.12278.
Reference Type
BACKGROUND
Ucakhan O, Arslanturk-Eren M. The Role of Soft Contact Lens Wear on Meibomian Gland Morphology and Function. Eye Contact Lens. 2019 Sep;45(5):292-300. doi: 10.1097/ICL.0000000000000572.
Reference Type
BACKGROUND
Insua Pereira E, Sampaio AP, Lira M. Effects of contact lens wear on tear inflammatory biomarkers. Cont Lens Anterior Eye. 2022 Oct;45(5):101600. doi: 10.1016/j.clae.2022.101600. Epub 2022 Apr 21.
Reference Type
BACKGROUND
Alzahrani Y, Colorado LH, Pritchard N, Efron N. Longitudinal changes in Langerhans cell density of the cornea and conjunctiva in contact lens-induced dry eye. Clin Exp Optom. 2017 Jan;100(1):33-40. doi: 10.1111/cxo.12399. Epub 2016 Jun 28.
Reference Type
BACKGROUND
Efron N. Contact lens wear is intrinsically inflammatory. Clin Exp Optom. 2017 Jan;100(1):3-19. doi: 10.1111/cxo.12487. Epub 2016 Nov 2.
Reference Type
BACKGROUND
Periman LM, Mah FS, Karpecki PM. A Review of the Mechanism of Action of Cyclosporine A: The Role of Cyclosporine A in Dry Eye Disease and Recent Formulation Developments. Clin Ophthalmol. 2020 Dec 2;14:4187-4200. doi: 10.2147/OPTH.S279051. eCollection 2020.
Reference Type
BACKGROUND
Wan KH, Chen LJ, Young AL. Efficacy and Safety of Topical 0.05% Cyclosporine Eye Drops in the Treatment of Dry Eye Syndrome: A Systematic Review and Meta-analysis. Ocul Surf. 2015 Jul;13(3):213-25. doi: 10.1016/j.jtos.2014.12.006. Epub 2015 Apr 11.
Reference Type
BACKGROUND
Rao SN. Topical cyclosporine 0.05% for the prevention of dry eye disease progression. J Ocul Pharmacol Ther. 2010 Apr;26(2):157-64. doi: 10.1089/jop.2009.0091.
Reference Type
BACKGROUND
Chen M, Gong L, Sun X, Xie H, Zhang Y, Zou L, Qu J, Li Y, He J. A comparison of cyclosporine 0.05% ophthalmic emulsion versus vehicle in Chinese patients with moderate to severe dry eye disease: an eight-week, multicenter, randomized, double-blind, parallel-group trial. J Ocul Pharmacol Ther. 2010 Aug;26(4):361-6. doi: 10.1089/jop.2009.0145.
Reference Type
BACKGROUND
Prabhasawat P, Tesavibul N, Mahawong W. A randomized double-masked study of 0.05% cyclosporine ophthalmic emulsion in the treatment of meibomian gland dysfunction. Cornea. 2012 Dec;31(12):1386-93. doi: 10.1097/ICO.0b013e31823cc098.
Reference Type
BACKGROUND
Chen D, Zhang S, Bian A, Hong J, Deng Y, Zhang M, Chen W, Shao Y, Zhao J. Efficacy and safety of 0.05% cyclosporine ophthalmic emulsion in treatment of Chinese patients with moderate to severe dry eye disease: A 12-week, multicenter, randomized, double-masked, placebo-controlled phase III clinical study. Medicine (Baltimore). 2019 Aug;98(31):e16710. doi: 10.1097/MD.0000000000016710.
Reference Type
BACKGROUND
Hom MM. Use of cyclosporine 0.05% ophthalmic emulsion for contact lens-intolerant patients. Eye Contact Lens. 2006 Mar;32(2):109-11. doi: 10.1097/01.icl.0000175651.30487.58.
Reference Type
BACKGROUND
Willen CM, McGwin G, Liu B, Owsley C, Rosenstiel C. Efficacy of cyclosporine 0.05% ophthalmic emulsion in contact lens wearers with dry eyes. Eye Contact Lens. 2008 Jan;34(1):43-5. doi: 10.1097/ICL.0b013e3180676d44.
Reference Type
BACKGROUND
Wang L, Chen X, Hao J, Yang L. Proper balance of omega-3 and omega-6 fatty acid supplements with topical cyclosporine attenuated contact lens-related dry eye syndrome. Inflammopharmacology. 2016 Dec;24(6):389-396. doi: 10.1007/s10787-016-0291-2. Epub 2016 Oct 20.
Reference Type
BACKGROUND
Jerkins GW, Pattar GR, Kannarr SR. A Review of Topical Cyclosporine A Formulations-A Disease-Modifying Agent for Keratoconjunctivitis Sicca. Clin Ophthalmol. 2020 Feb 20;14:481-489. doi: 10.2147/OPTH.S228070. eCollection 2020.
Reference Type
BACKGROUND
Mandal A, Gote V, Pal D, Ogundele A, Mitra AK. Ocular Pharmacokinetics of a Topical Ophthalmic Nanomicellar Solution of Cyclosporine (Cequa(R)) for Dry Eye Disease. Pharm Res. 2019 Jan 7;36(2):36. doi: 10.1007/s11095-018-2556-5.
Reference Type
BACKGROUND
Weiss SL, Kramer WG. Ocular Distribution of Cyclosporine Following Topical Administration of OTX-101 in New Zealand White Rabbits. J Ocul Pharmacol Ther. 2019 Sep;35(7):395-402. doi: 10.1089/jop.2018.0106. Epub 2019 Aug 6.
Reference Type
BACKGROUND
Malhotra R, Devries DK, Luchs J, Kabat A, Schechter BA, Shen Lee B, Shettle L, Smyth-Medina R, Ogundele A, Darby C, Bacharach J, Karpecki P. Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Corneal Staining in Patients With Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies. Cornea. 2019 Oct;38(10):1259-1265. doi: 10.1097/ICO.0000000000001989.
Reference Type
BACKGROUND
Smyth-Medina R, Johnston J, Devries DK, Jasper A, Kannarr SR, Schechter BA, Shen Lee B, Varghese G, Ogundele A, Darby CH, Karpecki P, Luchs J. Effect of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, on Conjunctival Staining in Patients with Keratoconjunctivitis Sicca: A Pooled Analysis of Phase 2b/3 and 3 Clinical Trials. J Ocul Pharmacol Ther. 2019 Sep;35(7):388-394. doi: 10.1089/jop.2018.0154. Epub 2019 Aug 2.
Reference Type
BACKGROUND
Sheppard J, Kannarr S, Luchs J, Malhotra R, Justice A, Ogundele A, Darby C, Bacharach J. Efficacy and Safety of OTX-101, a Novel Nanomicellar Formulation of Cyclosporine A, for the Treatment of Keratoconjunctivitis Sicca: Pooled Analysis of a Phase 2b/3 and Phase 3 Study. Eye Contact Lens. 2020 Jan;46 Suppl 1:S14-S19. doi: 10.1097/ICL.0000000000000636.
Reference Type
BACKGROUND
Toyos M, Gupta PK, Mitchell B, Karpecki P. The Effect of OTX-101 on Tear Production in Patients with Severe Tear-deficient Dry Eye Disease: A Pooled Analysis of Phase 2b/3 and Phase 3 Studies. Curr Eye Res. 2022 Feb;47(2):220-224. doi: 10.1080/02713683.2021.1966477. Epub 2021 Aug 29.
Reference Type
BACKGROUND
Sheppard J, Bergmann M, Schechter BA, Luchs J, Ogundele A, Karpecki P. Phase 3 Efficacy (Worse-Eye Analysis) and Long-Term Safety Evaluation of OTX-101 in Patients with Keratoconjunctivitis Sicca. Clin Ophthalmol. 2021 Jan 12;15:129-140. doi: 10.2147/OPTH.S279364. eCollection 2021.
Reference Type
BACKGROUND
Raulin C, Greve B, Grema H. IPL technology: a review. Lasers Surg Med. 2003;32(2):78-87. doi: 10.1002/lsm.10145.
Reference Type
BACKGROUND
Rennick S, Adcock L. Intense Pulsed Light Therapy for Meibomian Gland Dysfunction: A Review of Clinical Effectiveness and Guidelines [Internet]. Ottawa (ON): Canadian Agency for Drugs and Technologies in Health; 2018 Feb 8. Available from http://www.ncbi.nlm.nih.gov/books/NBK531789/
Reference Type
BACKGROUND
Dell SJ. Intense pulsed light for evaporative dry eye disease. Clin Ophthalmol. 2017 Jun 20;11:1167-1173. doi: 10.2147/OPTH.S139894. eCollection 2017.
Reference Type
BACKGROUND
Giannaccare G, Taroni L, Senni C, Scorcia V. Intense Pulsed Light Therapy In The Treatment Of Meibomian Gland Dysfunction: Current Perspectives. Clin Optom (Auckl). 2019 Oct 17;11:113-126. doi: 10.2147/OPTO.S217639. eCollection 2019.
Reference Type
BACKGROUND
Suwal A, Hao JL, Zhou DD, Liu XF, Suwal R, Lu CW. Use of Intense Pulsed Light to Mitigate Meibomian Gland Dysfunction for Dry Eye Disease. Int J Med Sci. 2020 Jun 1;17(10):1385-1392. doi: 10.7150/ijms.44288. eCollection 2020.
Reference Type
BACKGROUND
Craig JP, Chen YH, Turnbull PR. Prospective trial of intense pulsed light for the treatment of meibomian gland dysfunction. Invest Ophthalmol Vis Sci. 2015 Feb 12;56(3):1965-70. doi: 10.1167/iovs.14-15764.
Reference Type
BACKGROUND
Piyacomn Y, Kasetsuwan N, Reinprayoon U, Satitpitakul V, Tesapirat L. Efficacy and Safety of Intense Pulsed Light in Patients With Meibomian Gland Dysfunction-A Randomized, Double-Masked, Sham-Controlled Clinical Trial. Cornea. 2020 Mar;39(3):325-332. doi: 10.1097/ICO.0000000000002204.
Reference Type
BACKGROUND
Xue AL, Wang MTM, Ormonde SE, Craig JP. Randomised double-masked placebo-controlled trial of the cumulative treatment efficacy profile of intense pulsed light therapy for meibomian gland dysfunction. Ocul Surf. 2020 Apr;18(2):286-297. doi: 10.1016/j.jtos.2020.01.003. Epub 2020 Jan 30.
Reference Type
BACKGROUND
Toyos R, Desai NR, Toyos M, Dell SJ. Intense pulsed light improves signs and symptoms of dry eye disease due to meibomian gland dysfunction: A randomized controlled study. PLoS One. 2022 Jun 23;17(6):e0270268. doi: 10.1371/journal.pone.0270268. eCollection 2022.
Reference Type
BACKGROUND
Miao S, Yan R, Jia Y, Pan Z. Effect of Intense Pulsed Light Therapy in Dry Eye Disease Caused by Meibomian Gland Dysfunction: A Systematic Review and Meta-Analysis. Eye Contact Lens. 2022 Oct 1;48(10):424-429. doi: 10.1097/ICL.0000000000000934. Epub 2022 Sep 5.
Reference Type
BACKGROUND
Sambhi RS, Sambhi GDS, Mather R, Malvankar-Mehta MS. Intense pulsed light therapy with meibomian gland expression for dry eye disease. Can J Ophthalmol. 2020 Jun;55(3):189-198. doi: 10.1016/j.jcjo.2019.11.009. Epub 2020 Jan 13.
Reference Type
BACKGROUND
Arita R, Fukuoka S, Morishige N. Therapeutic efficacy of intense pulsed light in patients with refractory meibomian gland dysfunction. Ocul Surf. 2019 Jan;17(1):104-110. doi: 10.1016/j.jtos.2018.11.004. Epub 2018 Nov 13.
Reference Type
BACKGROUND
Rong B, Tang Y, Tu P, Liu R, Qiao J, Song W, Toyos R, Yan X. Intense Pulsed Light Applied Directly on Eyelids Combined with Meibomian Gland Expression to Treat Meibomian Gland Dysfunction. Photomed Laser Surg. 2018 Jun;36(6):326-332. doi: 10.1089/pho.2017.4402. Epub 2018 Apr 24.
Reference Type
BACKGROUND
Shin KY, Lim DH, Moon CH, Kim BJ, Chung TY. Intense pulsed light plus meibomian gland expression versus intense pulsed light alone for meibomian gland dysfunction: A randomized crossover study. PLoS One. 2021 Mar 4;16(3):e0246245. doi: 10.1371/journal.pone.0246245. eCollection 2021.
Reference Type
BACKGROUND
Yang L, Pazo EE, Zhang Q, Wu Y, Song Y, Qin G, Zhang H, Li J, Xu L, He W. Treatment of contact lens related dry eye with intense pulsed light. Cont Lens Anterior Eye. 2022 Apr;45(2):101449. doi: 10.1016/j.clae.2021.101449. Epub 2021 Apr 28.
Reference Type
BACKGROUND
Xu L, Wu Y, Song Y, Zhang Q, Qin G, Yang L, Ma J, Palme C, Moore JE, Pazo EE, He W. Comparison Between Heated Eye Mask and Intense Pulsed Light Treatment for Contact Lens-Related Dry Eye. Photobiomodul Photomed Laser Surg. 2022 Mar;40(3):189-197. doi: 10.1089/photob.2021.0094.
Reference Type
BACKGROUND
Yan S, Wu Y. Efficacy and safety of Intense pulsed light therapy for dry eye caused by meibomian gland dysfunction: a randomised trial. Ann Palliat Med. 2021 Jul;10(7):7857-7865. doi: 10.21037/apm-21-1303.
Reference Type
BACKGROUND
Lortie-Milner E, Boily L, Michaud L, Quesnel NM, Simard P, Milner V, Boissy P. Translation and validation of the contact lens dry eye questionnaire 8 (CLDEQ-8) in Canadian French. Cont Lens Anterior Eye. 2023 Apr;46(2):101779. doi: 10.1016/j.clae.2022.101779. Epub 2022 Dec 6.
Reference Type
BACKGROUND
Tauber J, Schechter BA, Bacharach J, Toyos MM, Smyth-Medina R, Weiss SL, Luchs JI. A Phase II/III, randomized, double-masked, vehicle-controlled, dose-ranging study of the safety and efficacy of OTX-101 in the treatment of dry eye disease. Clin Ophthalmol. 2018 Oct 2;12:1921-1929. doi: 10.2147/OPTH.S175065. eCollection 2018.
Reference Type
BACKGROUND
Downie LE, Gad A, Wong CY, Gray JHV, Zeng W, Jackson DC, Vingrys AJ. Modulating Contact Lens Discomfort With Anti-Inflammatory Approaches: A Randomized Controlled Trial. Invest Ophthalmol Vis Sci. 2018 Jul 2;59(8):3755-3766. doi: 10.1167/iovs.18-24758.
Reference Type
BACKGROUND
Downie LE. Automated Tear Film Surface Quality Breakup Time as a Novel Clinical Marker for Tear Hyperosmolarity in Dry Eye Disease. Invest Ophthalmol Vis Sci. 2015 Nov;56(12):7260-8. doi: 10.1167/iovs.15-17772.
Reference Type
BACKGROUND
Walker MK, Tomiyama ES, Skidmore KV, Assaad JR, Ticak A, Richdale K. A comparison of subjective and objective conjunctival hyperaemia grading with AOS(R) Anterior software. Clin Exp Optom. 2022 Jul;105(5):494-499. doi: 10.1080/08164622.2021.1945406. Epub 2021 Jul 27.
Reference Type
BACKGROUND
Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29.
Reference Type
BACKGROUND
Fagehi R, Al-Bishry AB, Alanazi MA, Abusharha A, El-Hiti GA, Masmali AM. Investigation of the repeatability of tear osmolarity using an I-PEN osmolarity device. Taiwan J Ophthalmol. 2020 Dec 17;11(2):168-174. doi: 10.4103/tjo.tjo_65_20. eCollection 2021 Apr-Jun.
Reference Type
BACKGROUND
Pult H, Riede-Pult B. Comparison of subjective grading and objective assessment in meibography. Cont Lens Anterior Eye. 2013 Feb;36(1):22-7. doi: 10.1016/j.clae.2012.10.074. Epub 2012 Oct 27.
Reference Type
BACKGROUND
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024-5200
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
Comparison of Efficacy, Safety and Anti-Inflammatory Effect Between Topical 0.05%Cyclosporine A Emulsion and REFRESH® in Patients With Moderate to Severe Dry Eyes
NCT00704275
UNKNOWN
PHASE4
Effect of IKERVIS® Eye Drops Once Daily on the Quality of Vision in Dry Eye Disease Patients With Severe Keratitis
NCT03237936
COMPLETED
PHASE4
Efficacy of Topical Cyclosporine Versus Tears for Improving Visual Outcomes Following Multifocal IOL Implantation
NCT00349583
COMPLETED
PHASE4
Efficacy of Cyclosporine for the Prevention and Treatment of Dry Eye Symptoms Following LASIK or Photorefractive Keratectomy
NCT00349440
COMPLETED
PHASE4
Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus
NCT07239128
COMPLETED
EARLY_PHASE1
Non-interventional Study to Evaluate the Anti-inflammatory Effects and the Clinical Efficacy of Topical Water Free Cyclosporin 0.1% Eye Drops in Patients With Dry Eye Disease and Associated Ocular Surface Inflammation Non-responding to Artificial Tears
NCT07234318
NOT_YET_RECRUITING
Tear Film Stability and Improvement of Asthenopia: Efficacy Observation of 0.05% Cyclosporine in Dry Eye Patients With Short BUT
NCT06981104
COMPLETED
NA
Microvascular and Inflammatory Responses of 0.05 Cyclosporine Eye Drop (II) in Treatment of Dry Eye
NCT05131152
UNKNOWN
NA
Phase III Confirmatory Study of DE-089 Ophthalmic Solution in Patients With Dry Eye
NCT01240382
COMPLETED
PHASE3
Treatment of Dry Eye Syndrome With Cyclosporin A Eye Drops
NCT00001731
COMPLETED
PHASE2
A Study Evaluating the Efficacy and Safety of RCI001 Ophthalmic Solution Compared to Placebo in Subjects With Dry Eye
NCT07068958
NOT_YET_RECRUITING
PHASE2
Study to Evaluate the Safety, Tolerability, and Efficacy of OTX-CSI in Subjects With Dry Eye Disease.
NCT04362670
COMPLETED
PHASE1/PHASE2
Intense Pulsed Light Study for Dry Eye Disease
NCT03089580
COMPLETED
NA
NOVA22007 0.05% and 0.1% Cyclosporine Versus Vehicle for the Treatment of Dry Eye
NCT00739349
COMPLETED
PHASE2
A Safety, Tolerability and Pharmacokinetics Study of R932348 Eye Drops in Patients With Dry Eye Disease
NCT01733992
COMPLETED
PHASE1
Clinical Outcomes of Cyclosporine Eye Drops in Management of Herpetic Keratitis
NCT05720715
COMPLETED
PHASE4
IPL and MGX Versus MGX Alone in the Treatment of Dry Eye Disease Secondary to MGD
NCT03265652
COMPLETED
NA
A Clinical Trial to Evaluate the Corneal Endothelial Health of DED Subjects Treated With Cyclosporine
NCT06329661
COMPLETED
PHASE4
The Effect of 0.1% Topical Ciclosporin A for 12-weeks on the Eye Surface Immune Cells in Dry Eyes
NCT06898853
NOT_YET_RECRUITING
NA
Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-007)
NCT00548301
COMPLETED
PHASE3
Study of Cyclosporine in the Treatment of Dry Eye Syndrome (ST-603-005)
NCT00502073
COMPLETED
PHASE3
A Clinical Trial to Assess the Efficacy and Safety of Subjects With Dry Eye Disease
NCT06389214
COMPLETED
PHASE3
Improving Drop Instillation Comfort of a Cyclosporine A Solution
NCT05957211
COMPLETED
NA
AST Combined With 0.05% Cyclosporin Eye Drop Improve Corneal Nerve Density in Patients With SS Dry Eye
NCT06013436
COMPLETED
Safety Study of the Use of Topical Cyclosporine in the Treatment of Dry Eye Disease
NCT02004067
COMPLETED
PHASE4