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
UNKNOWN
Clinical Phase
PHASE1/PHASE2
Total Enrollment
102 participants
Study Classification
INTERVENTIONAL
Study Start Date
2020-01-20
Study Completion Date
2021-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Dry eye disease (DED) is a chronic ocular surface disease and the prevalence of DED has been reported as high as 50%. Recently, The international Dry Eyes Workshop II (DEWS II) defines dry eye as a "multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film, and accompanied by ocular symptoms, in which tear film instability and hyperosmolarity, ocular surface inflammation and damage, and neurosensory abnormalities play etiological roles". A study done by Yoon et al. on 31 patients with severe DED concluded that UCS eye drops are effective and safe in treating severe DED. Studies found that EGF, TGF-β, VEGF and vitamin A levels were significantly higher in UCS than peripheral blood serum(PBS) whereas IGF content was significantly higher in PBS than in CBS. Yoon et al. then conducted another study whereby he compared UCS to AS in treating both Sjögren syndrome and non- Sjögren syndrome patients with severe dry eyes. They concluded that UCS eye drops were more effective in decreasing symptoms and keratoepitheliopathy in severe dry eye syndrome and increasing goblet cell density in Sjögren syndrome compared with AS drops. Despite proven more effective in treating DED, serum eye drops are not yet widely manufactured due to a few reasons. This study is chosen because
1. Not many previous clinical trials done related to UCS eye drops.
2. There were only two clinical trials done before to compare the use of UCS eye drops versus conventional AT eye drops on Hansen's disease and acute ocular chemical burn injury population.
3. To apply the newer technology of Keratograph® 5M in DED assessment.
4. To initiate a proper standard operating procedure for production as well as delivery of serum eye drops which allowing out-patient treatment with serum eye drops possible.
1. Not many previous clinical trials done related to UCS eye drops.
2. There were only two clinical trials done before to compare the use of UCS eye drops versus conventional AT eye drops on Hansen's disease and acute ocular chemical burn injury population.
3. To apply the newer technology of Keratograph® 5M in DED assessment.
4. To initiate a proper standard operating procedure for production as well as delivery of serum eye drops which allowing out-patient treatment with serum eye drops possible.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Autologous Serum and Umbilical Cord Serum Eyedrops for Dry Eye Syndrome
NCT00442273
Dry Eye Syndrome
COMPLETED
NA
Effects of Topical Insulin on Levels of Tear Inflammatory Mediators
NCT04877210
Dry Eye
UNKNOWN
PHASE1
Efficacy and Acceptability of Two Lubricant Eye Drops
NCT00756678
Dry Eye Syndromes
COMPLETED
PHASE4
Efficacy of Nonsteroidal Anti-inflammatory Drugs in Treatment of Moderate and Severe Dry Eye Disease
NCT01562795
Moderate to Severe Dry Eye Syndrome
COMPLETED
NA
CG-101 Eye Drops in the Treatment of Dry Eye Syndrome
NCT06792903
Dry Eye
RECRUITING
EARLY_PHASE1
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
This is a prospective, single- blinded randomized clinical trial conducted in University Kebangsaan Malaysia Medical Centre (UKMMC). Umbilical cord serum will be provided by Pusat Darah Negara (National Blood Centre), Malaysia. All patients from Ophthalmology Clinic in UKM Medical Centre from December 2019 till December 2021 will be involved in this study. Patients who fulfill the inclusion criteria will be included in this study. Informed consent will be taken and dry eye assessment that includes visual acuity, OSDI score, Schirmer test, NITBUT, corneal fluorescein staining, TMH and conjunctival injection. The patients will be randomised into 2 groups; AT eye drops and UCS eye drops.
Human umbilical cord blood samples will be collected from Maternity Hospital, Hospital Kuala Lumpur with assistance of the nurses from Cord Blood Collection Unit. All maternal blood samples were collected after the written informed consent from respective parents and subjected for virology screening.
National Blood Bank has a procedure for virology screening and all collected maternal umbilical cord bloods will be screened for Hep B Surface Antigen, Anti-HCV Ag/Ab, HIV Ag/Ab, Syphillis and Cytomegalovirus (CMV) IgM in Transfusion Microbiology Laborator (Accredited by ISO 15189 and CSL). Method that has been used in the screening as below:
* Hep B Surface Antigen, Anti-HCV, HIV Ag/Ab: Chemiluminescent Microparticle Immunoassay (CMIA).
* Syphilis : Carbon Antigen (Manual)
* CMV IgM : Electrochemiluminescence Immunoassay (ECLIA)
Whereas, the CB samples are screened for bacteriology screening pre and post processing to ensure sterility of the product. The serum will be discarded if any of the laboratory results are positive or reactive.
The collected cord blood (CB) will then be placed in an incubator at the collection centre until the cord blood samples are sent to National Blood Bank in an ice box with temperature logger. Once the ice box reached National Blood Bank, MLT will check the temperature logger and make sure all the temperature data within range (10-26oC) before starting the UCS serum eye drops production.
CB will be processed in Cord Blood Processing Unit within 24 hours of collection to ensure retrieval of high quality of bioactive molecules. Laboratory temperature room, humidity and oxygen will be monitored twice a day. Upon arrival at the processing laboratory, the CB will then be left at room temperature for about 2 hours to allow the CB to clot completely. After 15 minutes of centrifugation at 3,000 × g, under sterile conditions, the serum fraction will be carefully separated from the cellular fraction. Separated serum is then transferred to a tygon tube by using a sterile docking device and diluted to a 20% dilution with balanced salt solution (BSS) without any antibiotics, and finally sealed into 1-inch segment consisting of approximately 1 ml serum eye drops. The segmented UCS will then be frozen at -20oC for 3 to 6 months or at -80°C for long term storage.
For safety and quality interest, frozen segments will be transported to UKMMC blood bank using a transportation box filled with dry ice to ensure UCS are at frozen state and to maintain the quality of the product until they reach destination. From UKMMC blood bank, participants will need to bring the frozen UCS eye drops home by transporting them in a cooler box with ice packs. At home, the frozen UCS eye drops will need to be kept in domestic freezer. The frozen UCS eye drops must be thawed at room temperature prior to usage and thereafter stored in the refrigerator at 2-8°C for a maximum of 24 hours. A short instruction sheet will be provided to participants on UCS usage. There will be no porcine/bovine materials involved in the whole process.
Statistical analysis will be performed using Statistical Package for Social Science, version 20.0 (SPSS, Inc., Chicago, III., USA) for Windows. Mean value comparisons between study groups can be performed with the Student's T-test using 2 sided-analysis. Mean value comparisons for follow up can be analysed with ANOVA. Categorical characteristics can be analyzed using a Chi-square. Differences are considered statistically significant at P\<0.05.
Human umbilical cord blood samples will be collected from Maternity Hospital, Hospital Kuala Lumpur with assistance of the nurses from Cord Blood Collection Unit. All maternal blood samples were collected after the written informed consent from respective parents and subjected for virology screening.
National Blood Bank has a procedure for virology screening and all collected maternal umbilical cord bloods will be screened for Hep B Surface Antigen, Anti-HCV Ag/Ab, HIV Ag/Ab, Syphillis and Cytomegalovirus (CMV) IgM in Transfusion Microbiology Laborator (Accredited by ISO 15189 and CSL). Method that has been used in the screening as below:
* Hep B Surface Antigen, Anti-HCV, HIV Ag/Ab: Chemiluminescent Microparticle Immunoassay (CMIA).
* Syphilis : Carbon Antigen (Manual)
* CMV IgM : Electrochemiluminescence Immunoassay (ECLIA)
Whereas, the CB samples are screened for bacteriology screening pre and post processing to ensure sterility of the product. The serum will be discarded if any of the laboratory results are positive or reactive.
The collected cord blood (CB) will then be placed in an incubator at the collection centre until the cord blood samples are sent to National Blood Bank in an ice box with temperature logger. Once the ice box reached National Blood Bank, MLT will check the temperature logger and make sure all the temperature data within range (10-26oC) before starting the UCS serum eye drops production.
CB will be processed in Cord Blood Processing Unit within 24 hours of collection to ensure retrieval of high quality of bioactive molecules. Laboratory temperature room, humidity and oxygen will be monitored twice a day. Upon arrival at the processing laboratory, the CB will then be left at room temperature for about 2 hours to allow the CB to clot completely. After 15 minutes of centrifugation at 3,000 × g, under sterile conditions, the serum fraction will be carefully separated from the cellular fraction. Separated serum is then transferred to a tygon tube by using a sterile docking device and diluted to a 20% dilution with balanced salt solution (BSS) without any antibiotics, and finally sealed into 1-inch segment consisting of approximately 1 ml serum eye drops. The segmented UCS will then be frozen at -20oC for 3 to 6 months or at -80°C for long term storage.
For safety and quality interest, frozen segments will be transported to UKMMC blood bank using a transportation box filled with dry ice to ensure UCS are at frozen state and to maintain the quality of the product until they reach destination. From UKMMC blood bank, participants will need to bring the frozen UCS eye drops home by transporting them in a cooler box with ice packs. At home, the frozen UCS eye drops will need to be kept in domestic freezer. The frozen UCS eye drops must be thawed at room temperature prior to usage and thereafter stored in the refrigerator at 2-8°C for a maximum of 24 hours. A short instruction sheet will be provided to participants on UCS usage. There will be no porcine/bovine materials involved in the whole process.
Statistical analysis will be performed using Statistical Package for Social Science, version 20.0 (SPSS, Inc., Chicago, III., USA) for Windows. Mean value comparisons between study groups can be performed with the Student's T-test using 2 sided-analysis. Mean value comparisons for follow up can be analysed with ANOVA. Categorical characteristics can be analyzed using a Chi-square. Differences are considered statistically significant at P\<0.05.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Dry Eye Syndromes
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
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Participants
Caregivers
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
A-AT eye drops
Optive Fusion UD eye drops + Genteal lubricant gel
Group Type
ACTIVE_COMPARATOR
Optive, Ophthalmic Solution
Intervention Type
DRUG
6 drops per day, for 8 weeks
Genteal lubricant gel
Intervention Type
DRUG
Genteal lubricant gel (2 drops per day, for 8 weeks)
B-UCS eye drops
UCS eye drops + GentTeal lubricant gel
Group Type
ACTIVE_COMPARATOR
Umbilical Cord Serum eye drops
Intervention Type
BIOLOGICAL
UCS eye drops (6 drops per day, for 8 weeks)
Genteal lubricant gel
Intervention Type
DRUG
Genteal lubricant gel (2 drops per day, for 8 weeks)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Optive, Ophthalmic Solution
6 drops per day, for 8 weeks
Intervention Type
DRUG
Umbilical Cord Serum eye drops
UCS eye drops (6 drops per day, for 8 weeks)
Intervention Type
BIOLOGICAL
Genteal lubricant gel
Genteal lubricant gel (2 drops per day, for 8 weeks)
Intervention Type
DRUG
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Optive Fusion UD
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Moderate to severe Dry Eye Disease based on OSDI score or DED severity grading scheme
* Patients willing to participate in this study and able to provide consent
* Patients with domestic freezer at home
* Patients willing to participate in this study and able to provide consent
* Patients with domestic freezer at home
Exclusion Criteria
* Infective cases
* Cases with limbal stem cells deficiency
* Patients with lid abnormalities
* Allergic to study eye drops component
* Cases with limbal stem cells deficiency
* Patients with lid abnormalities
* Allergic to study eye drops component
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.
National University of Malaysia
OTHER
Sponsor Role
lead
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wan Haslina Wan Abdul Halim
Consultant Ophthalmologist-Cornea And Anterior Segment
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wan Haslina Wan Abdul Halim, M.D(UKM)
Role: STUDY_CHAIR
National University of Malaysia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
UKM Medical Centre
Cheras, Kuala Lumpur, Malaysia
Site Status
RECRUITING
National Blood Centre, Malaysia
Kuala Lumpur, Kuala Lumpur, Malaysia
Site Status
ENROLLING_BY_INVITATION
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, Malaysia
Site Status
NOT_YET_RECRUITING
Countries
Review the countries where the study has at least one active or historical site.
Malaysia
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.
Lemp MA. Report of the National Eye Institute/Industry workshop on Clinical Trials in Dry Eyes. CLAO J. 1995 Oct;21(4):221-32. No abstract available.
Reference Type
BACKGROUND
Aggarwal S, Kheirkhah A, Cavalcanti BM, Cruzat A, Colon C, Brown E, Borsook D, Pruss H, Hamrah P. Autologous Serum Tears for Treatment of Photoallodynia in Patients with Corneal Neuropathy: Efficacy and Evaluation with In Vivo Confocal Microscopy. Ocul Surf. 2015 Jul;13(3):250-62. doi: 10.1016/j.jtos.2015.01.005. Epub 2015 Feb 20.
Reference Type
BACKGROUND
The definition and classification of dry eye disease: report of the Definition and Classification Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007 Apr;5(2):75-92. doi: 10.1016/s1542-0124(12)70081-2.
Reference Type
BACKGROUND
Bradley JC, Simoni J, Bradley RH, McCartney DL, Brown SM. Time- and temperature-dependent stability of growth factor peptides in human autologous serum eye drops. Cornea. 2009 Feb;28(2):200-5. doi: 10.1097/ICO.0b013e318186321e.
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
Celebi AR, Ulusoy C, Mirza GE. The efficacy of autologous serum eye drops for severe dry eye syndrome: a randomized double-blind crossover study. Graefes Arch Clin Exp Ophthalmol. 2014 Apr;252(4):619-26. doi: 10.1007/s00417-014-2599-1. Epub 2014 Feb 25.
Reference Type
BACKGROUND
Chiang CC, Lin JM, Chen WL, Tsai YY. Allogeneic serum eye drops for the treatment of severe dry eye in patients with chronic graft-versus-host disease. Cornea. 2007 Aug;26(7):861-3. doi: 10.1097/ICO.0b013e3180645cd7.
Reference Type
BACKGROUND
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
Dietrich T, Weisbach V, Seitz B, Jacobi C, Kruse FE, Eckstein R, Cursiefen C. [Manufacture of autologous serum eye drops for out-patient therapy : cooperation between ophthalmic clinic and transfusion medicine department]. Ophthalmologe. 2008 Nov;105(11):1036-8, 1040-2. doi: 10.1007/s00347-008-1692-4. German.
Reference Type
BACKGROUND
Esquenazi S, He J, Bazan HE, Bazan NG. Use of autologous serum in corneal epithelial defects post-lamellar surgery. Cornea. 2005 Nov;24(8):992-7. doi: 10.1097/01.ico.0000160967.65953.ea.
Reference Type
BACKGROUND
Farrand KF, Fridman M, Stillman IO, Schaumberg DA. Prevalence of Diagnosed Dry Eye Disease in the United States Among Adults Aged 18 Years and Older. Am J Ophthalmol. 2017 Oct;182:90-98. doi: 10.1016/j.ajo.2017.06.033. Epub 2017 Jul 10.
Reference Type
BACKGROUND
Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
Reference Type
BACKGROUND
Foulks, G., Lemp, M., Jester, J., Sutphin, J., Murube, J. & Novack, G. 2007. Report of the International Dry Eye Workshop (Dews). Ocul Surf 5(2): 65-204.
Reference Type
BACKGROUND
Guo B, Lu P, Chen X, Zhang W, Chen R. Prevalence of dry eye disease in Mongolians at high altitude in China: the Henan eye study. Ophthalmic Epidemiol. 2010 Aug;17(4):234-41. doi: 10.3109/09286586.2010.498659.
Reference Type
BACKGROUND
Hussain M, Shtein RM, Sugar A, Soong HK, Woodward MA, DeLoss K, Mian SI. Long-term use of autologous serum 50% eye drops for the treatment of dry eye disease. Cornea. 2014 Dec;33(12):1245-51. doi: 10.1097/ICO.0000000000000271.
Reference Type
BACKGROUND
Jirsova K, Brejchova K, Krabcova I, Filipec M, Al Fakih A, Palos M, Vesela V. The application of autologous serum eye drops in severe dry eye patients; subjective and objective parameters before and after treatment. Curr Eye Res. 2014 Jan;39(1):21-30. doi: 10.3109/02713683.2013.824987. Epub 2013 Sep 27.
Reference Type
BACKGROUND
Jones L, Downie LE, Korb D, Benitez-Del-Castillo JM, Dana R, Deng SX, Dong PN, Geerling G, Hida RY, Liu Y, Seo KY, Tauber J, Wakamatsu TH, Xu J, Wolffsohn JS, Craig JP. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017 Jul;15(3):575-628. doi: 10.1016/j.jtos.2017.05.006. Epub 2017 Jul 20.
Reference Type
BACKGROUND
Kojima T, Ishida R, Dogru M, Goto E, Matsumoto Y, Kaido M, Tsubota K. The effect of autologous serum eyedrops in the treatment of severe dry eye disease: a prospective randomized case-control study. Am J Ophthalmol. 2005 Feb;139(2):242-6. doi: 10.1016/j.ajo.2004.08.040.
Reference Type
BACKGROUND
Lemp MA, Crews LA, Bron AJ, Foulks GN, Sullivan BD. Distribution of aqueous-deficient and evaporative dry eye in a clinic-based patient cohort: a retrospective study. Cornea. 2012 May;31(5):472-8. doi: 10.1097/ICO.0b013e318225415a.
Reference Type
BACKGROUND
Lopez-Garcia JS, Garcia-Lozano I, Rivas L, Gimenez C, Acera A, Suarez-Cortes T. Effects of Autologous Serum Eye Drops on Conjunctival Expression of MUC5AC in Patients With Ocular Surface Disorders. Cornea. 2016 Mar;35(3):336-41. doi: 10.1097/ICO.0000000000000726.
Reference Type
BACKGROUND
Moh, M. O. H. M. 2009. Keputusan Muzakarah Jawatankuasa Fatwa Majlis Kebangsaan Bagi Hal Ehwal Agama Islam Malaysia Berkaitan Pengklonan Dan Art. 2nd Edition Malaysian Guidelines for Stem Cell Research and Therapy
Reference Type
BACKGROUND
Noble BA, Loh RS, MacLennan S, Pesudovs K, Reynolds A, Bridges LR, Burr J, Stewart O, Quereshi S. Comparison of autologous serum eye drops with conventional therapy in a randomised controlled crossover trial for ocular surface disease. Br J Ophthalmol. 2004 May;88(5):647-52. doi: 10.1136/bjo.2003.026211.
Reference Type
BACKGROUND
Noda-Tsuruya T, Asano-Kato N, Toda I, Tsubota K. Autologous serum eye drops for dry eye after LASIK. J Refract Surg. 2006 Jan-Feb;22(1):61-6. doi: 10.3928/1081-597X-20060101-13.
Reference Type
BACKGROUND
Rahman, A. a. A., Badarudin, N. E., Azemin, M. Z. C. & Ariffin, A. E. 2017. Development of a Bahasa Melayu Version of Ocular Surface Disease Index (Osdi). INTERNATIONAL JOURNAL OF ALLIED HEALTH SCIENCES 1(1):
Reference Type
BACKGROUND
Ralph RA, Doane MG, Dohlman CH. Clinical experience with a mobile ocular perfusion pump. Arch Ophthalmol. 1975 Oct;93(10):1039-43. doi: 10.1001/archopht.1975.01010020815015.
Reference Type
BACKGROUND
Uchino M, Schaumberg DA. Dry Eye Disease: Impact on Quality of Life and Vision. Curr Ophthalmol Rep. 2013 Jun;1(2):51-57. doi: 10.1007/s40135-013-0009-1.
Reference Type
BACKGROUND
Urzua CA, Vasquez DH, Huidobro A, Hernandez H, Alfaro J. Randomized double-blind clinical trial of autologous serum versus artificial tears in dry eye syndrome. Curr Eye Res. 2012 Aug;37(8):684-8. doi: 10.3109/02713683.2012.674609. Epub 2012 Jun 6.
Reference Type
BACKGROUND
Wolffsohn JS, Arita R, Chalmers R, Djalilian A, Dogru M, Dumbleton K, Gupta PK, Karpecki P, Lazreg S, Pult H, Sullivan BD, Tomlinson A, Tong L, Villani E, Yoon KC, Jones L, Craig JP. TFOS DEWS II Diagnostic Methodology report. Ocul Surf. 2017 Jul;15(3):539-574. doi: 10.1016/j.jtos.2017.05.001. Epub 2017 Jul 20.
Reference Type
BACKGROUND
Jeong, S. & Lee, S. B. 2016. Reliability of a New Non-Invasive Tear Film Break-up Time Measurement Using a Keratograph. Journal of the Korean Ophthalmological Society 57(9): 1354-1360.
Reference Type
RESULT
Mukhopadhyay S, Sen S, Datta H. Comparative role of 20% cord blood serum and 20% autologous serum in dry eye associated with Hansen's disease: a tear proteomic study. Br J Ophthalmol. 2015 Jan;99(1):108-12. doi: 10.1136/bjophthalmol-2013-304801. Epub 2014 Aug 19.
Reference Type
RESULT
Rauz S, Koay SY, Foot B, Kaye SB, Figueiredo F, Burdon MA, Dancey E, Chandrasekar A, Lomas R. The Royal College of Ophthalmologists guidelines on serum eye drops for the treatment of severe ocular surface disease: full report. Eye (Lond). 2017 Nov 17. doi: 10.1038/eye.2017.209. Online ahead of print. No abstract available.
Reference Type
RESULT
Rauz S, Saw VP. Serum eye drops, amniotic membrane and limbal epithelial stem cells--tools in the treatment of ocular surface disease. Cell Tissue Bank. 2010 Feb;11(1):13-27. doi: 10.1007/s10561-009-9128-1. Epub 2009 Apr 22.
Reference Type
RESULT
Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
Reference Type
RESULT
Sharma N, Goel M, Velpandian T, Titiyal JS, Tandon R, Vajpayee RB. Evaluation of umbilical cord serum therapy in acute ocular chemical burns. Invest Ophthalmol Vis Sci. 2011 Feb 25;52(2):1087-92. doi: 10.1167/iovs.09-4170.
Reference Type
RESULT
Simmons PA, Liu H, Carlisle-Wilcox C, Vehige JG. Efficacy and safety of two new formulations of artificial tears in subjects with dry eye disease: a 3-month, multicenter, active-controlled, randomized trial. Clin Ophthalmol. 2015 Apr 15;9:665-75. doi: 10.2147/OPTH.S78184. eCollection 2015.
Reference Type
RESULT
Vajpayee RB, Mukerji N, Tandon R, Sharma N, Pandey RM, Biswas NR, Malhotra N, Melki SA. Evaluation of umbilical cord serum therapy for persistent corneal epithelial defects. Br J Ophthalmol. 2003 Nov;87(11):1312-6. doi: 10.1136/bjo.87.11.1312.
Reference Type
RESULT
Versura P, Buzzi M, Giannaccare G, Terzi A, Fresina M, Velati C, Campos EC. Targeting growth factor supply in keratopathy treatment: comparison between maternal peripheral blood and cord blood as sources for the preparation of topical eye drops. Blood Transfus. 2016 Mar;14(2):145-51. doi: 10.2450/2015.0020-15. Epub 2015 Jul 9.
Reference Type
RESULT
Yoon KC, Heo H, Im SK, You IC, Kim YH, Park YG. Comparison of autologous serum and umbilical cord serum eye drops for dry eye syndrome. Am J Ophthalmol. 2007 Jul;144(1):86-92. doi: 10.1016/j.ajo.2007.03.016. Epub 2007 May 9.
Reference Type
RESULT
Yoon KC, Im SK, Park YG, Jung YD, Yang SY, Choi J. Application of umbilical cord serum eyedrops for the treatment of dry eye syndrome. Cornea. 2006 Apr;25(3):268-72. doi: 10.1097/01.ico.0000183484.85636.b6.
Reference Type
RESULT
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
GGPM-2018-052
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FF-2019-209
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.
A Safety and Efficacy Study of a New Eye Drop Formulation in Patients With Dry Eye Disease.
NCT02553772
COMPLETED
PHASE3
Evaluation of Tear Osmolarity Over Time With Sustained Use of Thera Tears Lubricating Drops
NCT02758327
COMPLETED
PHASE4
Assess the Safety and Efficacy of CsA Ophthalmic Gel in Subjects With Dry Eye
NCT03676335
COMPLETED
PHASE2
Study on Safety and Performance of an Artificial Tear in Dry Eye Treatment in Subjects With Ocular Surface Inflammation
NCT04633863
COMPLETED
NA
Safety and Tolerability of Artificial Tears in Dry Eye Subjects
NCT00932477
COMPLETED
NA
A Dose Regimen Study of BRM421 Ophthalmic Solution in Patients With Dry Eye Disease
NCT07078955
NOT_YET_RECRUITING
PHASE2
Safety and Efficacy of Two Artificial Tears in Dry Eye Subjects
NCT01010282
COMPLETED
NA
Management of the Ocular Surface With Preservative-Free Lubricants in Patients With Dry Eye
NCT06162442
RECRUITING
Efficacy and Safety of a New Multi-dose Lubricant Eye Drop Concomitant With Restasis® (Cyclosporine A) for the Treatment of Dry Eye Symptoms
NCT00405457
COMPLETED
PHASE4
Wireless Micropump in Dry Eye Patients
NCT04667819
UNKNOWN
NA
A Study to Confirm the Efficacy and Safety of K-161 Ophthalmic Solution for Treatment of Moderate to Severe Dry Eye Disease
NCT05403827
COMPLETED
PHASE3
Efficacy and Safety of BUFY01 Versus SVS20 in the Treatment of Dry Eye Disease
NCT05865379
RECRUITING
NA
Safety and Efficacy of Kelulut Honey Eyedrops in Dry Eye Disease
NCT07279324
NOT_YET_RECRUITING
NA
A Randomized, Double Masked, Clinical Study of Subjects With Dry Eye Syndrome
NCT03162783
COMPLETED
PHASE2
Artificial Tears Study in Mild to Moderate Dry Eye Patients
NCT00607776
COMPLETED
PHASE2
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
Effects of Dry Eye Treatments on the Ocular Surface
NCT01797822
COMPLETED
PHASE4
Tear Osmolarity Clinical Utility in Dry Eye Disease
NCT02417116
COMPLETED
NA
Comparing the Quality of Topical Autologous Serum in Different Etiologies of Dry Eye Syndrome
NCT02774707
UNKNOWN
Dose-response Study of OPC-12759 Ophthalmic Suspension
NCT00234078
COMPLETED
PHASE2
Therapeutic Effect of Stem Cell Eye Drops on Dry Eye Disease
NCT05784519
UNKNOWN
EARLY_PHASE1
A Study to Compare a New Eye Drop Formulation With Systane® Gel Drops and Genteal® Lubricant Gel Drops for Moderate to Severe Dry Eye Relief
NCT02455050
COMPLETED
PHASE3
Study of Diquafosol Tetrasodium Ophthalmic Solution in Subjects With Dry Eye Disease
NCT00403975
COMPLETED
PHASE3
Virgin Coconut Oil Contact Lens as Ocular Rewetting Agent
NCT06071780
COMPLETED
NA