Sponsor study identifier
interventional
44
1 country
1
Study Start
April 25, 2024
Actual (reported)Primary Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 23, 2024
Actual (reported)April 25, 2024
Actual (reported)April 30, 2024
Actual (reported)September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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)
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
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.
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.
Unidose of Cequa provided without charge to the participant. 1 drop in each eye morning and evening.
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.
Opto-Réseau Sherbrooke Est
Sherbrooke, Quebec, J1E 2T1, Canada
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.
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.
Patrick Boissy, PhD
Professor University of Sherbrooke
Langis Michaud, OD, MSc
Professor University of Montreal
Eric Lortie-Milner, OD
PhD candidate University of Sherbrooke
First Submitted
April 23, 2024
First Posted
Effects of Supplementation With PUFAs and Antioxidants for Contact Lens Discomfort
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.
Contact the study team to confirm eligibility.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Raulin C, Greve B, Grema H. IPL technology: a review. Lasers Surg Med. 2003;32(2):78-87. doi: 10.1002/lsm.10145.
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/
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Efron N, Morgan PB, Katsara SS. Validation of grading scales for contact lens complications. Ophthalmic Physiol Opt. 2001 Jan;21(1):17-29.
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.
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.
Lortie-Milner E, Michaud L, Dubois MF, Boissy P. Combination of 0.09% cyclosporine and intense pulsed light (IPL) therapy for the treatment of dry eye disease in symptomatic contact lens wearers: study protocol for a sham-controlled randomized clinical trial. Trials. 2026 Feb 7;27(1):203. doi: 10.1186/s13063-026-09521-w.
April 30, 2024
Study Start
April 25, 2024
Actual (reported)Primary Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 1, 2024
Record last verified: 2024-04
Raw data and individual participant data (denominalized) will be available upon reasonable demand to the research team. Protocol article will be submitted for publication
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: