Dry Eye SyndromesPhase 1/2NCT04217785
Umbilical Cord Serum Versus Conventional Eyedrops
A Phase 1/2 study testing Optive, Ophthalmic Solution, Umbilical Cord Serum eye drops and Genteal lubricant gel in people with Dry Eye Syndromes, run by National University of Malaysia at 3 sites in Malaysia.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dry Eye Syndromes
- What is being tested?
- Optive, Ophthalmic Solution, Umbilical Cord Serum eye drops and Genteal lubricant gel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 3 sitesMalaysia
- Study dates
- 20 Jan 2020to May 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Infective cases
- Cases with limbal stem cells deficiency
- Patients with lid abnormalities
- Allergic to study eye drops component
Trial locations and contacts
3 sites in 1 country.
Malaysia3 sites, 3 recruiting
- Recruiting
UKM Medical Centre
Cheras, Kuala Lumpur, 56000
Wan Haslina Wan Abdul Halim, M.D, +6019-6679633, afifiyad@yahoo.co.uk
Wan Haslina Wan Abdul Halim, M.D
- Enrolling by invitation
National Blood Centre, Malaysia
Kuala Lumpur, Kuala Lumpur, 50400
- Not yet recruiting
Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50586
Rohanah Alias, M.D., +014-9761507, drrohanah71@yahoo.com
Rohanah Alias, M.D.
About this study
Official title: Umbilical Cord Serum Versus Conventional Eyedrops In Treatment of Moderate To Severe Dry Eye Disease: A Randomized Clinical Trial
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
- Not many previous clinical trials done related to UCS eye drops.
- 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.
- To apply the newer technology of Keratograph® 5M in DED assessment.
- 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.
Read the detailed description
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.
- Conditions
- Dry Eye Syndromes
- Being tested
- Optive, Ophthalmic Solution, Umbilical Cord Serum eye drops, Genteal lubricant gel
- Keywords
- Umbilical Cord Serum Eyedrops, Moderate To Severe Dry Eye
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optive, Ophthalmic SolutionDrug
Also called Optive Fusion UD
6 drops per day, for 8 weeks
Umbilical Cord Serum eye dropsBiological
UCS eye drops (6 drops per day, for 8 weeks)
Genteal lubricant gelDrug
Genteal lubricant gel (2 drops per day, for 8 weeks)
| Study group | Role | What they receive |
|---|---|---|
| A-AT eye drops | Active comparator | Optive Fusion UD eye drops + Genteal lubricant gel Receives: Drug: Optive, Ophthalmic Solution; Drug: Genteal lubricant gel |
| B-UCS eye drops | Active comparator | UCS eye drops + GentTeal lubricant gel Receives: Biological: Umbilical Cord Serum eye drops; Drug: Genteal lubricant gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of change in corneal surface in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change of non-invasive tear break-up time (s) and Tear Break-up Time (s) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 4th week of eyedrop instillation.
Measured: At 4th week of treatment
Comparison of change in corneal surface in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change of non-invasive tear break-up time (s) and Tear Break-up Time (s) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 8th week of eyedrop instillation.
Measured: At 8th week of treatment
Comparison of meniscometry (mm) in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change in tear meniscus height (mm) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 4th week of eyedrop instillation.
Measured: At 4th week of treatment
Comparison of meniscometry (mm) in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change in tear meniscus height (mm) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 8th week of eyedrop instillation.
Measured: At 8th week of treatment
Comparison of change in corneal surface signs in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change of Corneal surface signs (ie punctate epithelial erosions) from Baseline based on Oxford Scale Eye Grading through slit-lamp examination at 4th week of eyedrop instillation. The grade ranges from 0-5, in which higher scores indicate worse outcome.
Measured: At 4th week of treatment
Comparison of change in corneal surface signs in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change of Corneal surface signs (ie punctate epithelial erosions) from Baseline based on Oxford Scale Eye Grading through slit-lamp examination at 8th week of eyedrop instillation. The grade ranges from 0-5, in which higher scores indicate worse outcome.
Measured: At 8th week of treatment
Comparison of ocular surface redness in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change of ocular surface redness from Baseline based on Redness Scoring using Oculus Keratograph-5 Machine at 4th week of eyedrop instillation.
Measured: At 4th week of treatment
Comparison of ocular surface redness in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change of ocular surface redness from Baseline based on Redness Scoring using Oculus Keratograph-5 Machine at 8th week of eyedrop instillation.
Measured: At 8th week of treatment
Comparison of change in basal tear production in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change of basal tear production (mm) from Baseline through Schirmer's test at 4th week of eyedrop instillation.
Measured: At 4th week of treatment
Comparison of change in basal tear production in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change of basal tear production (mm) from Baseline through Schirmer's test at 8th week of eyedrop instillation.
Measured: At 8th week of treatment
Comparison of dry eye symptom improvements in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change of dry eye symptoms from baseline based on Ocular Surface Disease Index (OSDI) score at 4th week of eyedrop instillation.
Measured: At 4th week of treatment
Comparison of dry eye symptom improvements in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Change of dry eye symptoms from baseline based on Ocular Surface Disease Index (OSDI) score at 8th week of eyedrop instillation.
Measured: At 8th week of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2020
- Study start20 Jan 2020
- Primary completionDec 2020 (estimated)
- Study completionMay 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (39)Papers the sponsor has linked to this study.
- Other trials for Dry Eye SyndromesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan Haslina Wan Abdul Halim, National University of Malaysia
- Investigators
- Wan Haslina Wan Abdul Halim, M.D(UKM), Study chair, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04217785
- Sponsor's protocol ID
- FF-2019-209
- Other IDs
- GGPM-2018-052
- Status last verified
- Sep 2020
- First submitted
- 23 Dec 2019
- Last updated
- 21 Sep 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8565190Aggarwal 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.
PubMed 26045233The 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.
PubMed 17508116Bradley 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.
PubMed 19158565Bron 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.
PubMed 28736340Celebi 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.
PubMed 24566903Chiang 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.
PubMed 17667623Craig 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.
PubMed 28736335Dietrich 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.
PubMed 18506408Esquenazi 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.
PubMed 16227849Farrand 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.
PubMed 28705660Faul 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.
PubMed 17695343Foulks, 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.
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.
PubMed 20642346Hussain 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.
PubMed 25299423
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Serum Versus Conventional Eyedrops In Treatment of Moderate To Severe Dry Eye Disease: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04217785
- Acronym / sponsor ID
- FF-2019-209
- Conditions
- Dry Eye Syndromes
- Keywords
- Umbilical Cord Serum Eyedrops, Moderate To Severe Dry Eye
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 3 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Not many previous clinical trials done related to UCS eye drops.
- 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.
- To apply the newer technology of Keratograph® 5M in DED assessment.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A-AT eye drops | Active comparator | Drug: Optive, Ophthalmic Solution, Drug: Genteal lubricant gelOptive Fusion UD eye drops + Genteal lubricant gel |
| B-UCS eye drops | Active comparator | Biological: Umbilical Cord Serum eye drops, Drug: Genteal lubricant gelUCS eye drops + GentTeal lubricant gel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Infective cases
- Cases with limbal stem cells deficiency
- Patients with lid abnormalities
- Allergic to study eye drops component
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optive, Ophthalmic SolutionAlso: Optive Fusion UD6 drops per day, for 8 weeks | Drug | A-AT eye drops |
| Umbilical Cord Serum eye dropsUCS eye drops (6 drops per day, for 8 weeks) | Biological | B-UCS eye drops |
| Genteal lubricant gelGenteal lubricant gel (2 drops per day, for 8 weeks) | Drug | A-AT eye drops, B-UCS eye drops |
Primary outcome
Comparison of change in corneal surface in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 4th week of treatment
Change of non-invasive tear break-up time (s) and Tear Break-up Time (s) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 4th week of eyedrop instillation.
Comparison of change in corneal surface in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 8th week of treatment
Change of non-invasive tear break-up time (s) and Tear Break-up Time (s) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 8th week of eyedrop instillation.
Comparison of meniscometry (mm) in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 4th week of treatment
Change in tear meniscus height (mm) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 4th week of eyedrop instillation.
Comparison of meniscometry (mm) in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 8th week of treatment
Change in tear meniscus height (mm) of corneal surface from Baseline by using Oculus Keratograph-5 Machine at 8th week of eyedrop instillation.
Comparison of change in corneal surface signs in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 4th week of treatment
Change of Corneal surface signs (ie punctate epithelial erosions) from Baseline based on Oxford Scale Eye Grading through slit-lamp examination at 4th week of eyedrop instillation. The grade ranges from 0-5, in which higher scores indicate worse outcome.
Comparison of change in corneal surface signs in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 8th week of treatment
Change of Corneal surface signs (ie punctate epithelial erosions) from Baseline based on Oxford Scale Eye Grading through slit-lamp examination at 8th week of eyedrop instillation. The grade ranges from 0-5, in which higher scores indicate worse outcome.
Comparison of ocular surface redness in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 4th week of treatment
Change of ocular surface redness from Baseline based on Redness Scoring using Oculus Keratograph-5 Machine at 4th week of eyedrop instillation.
Comparison of ocular surface redness in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 8th week of treatment
Change of ocular surface redness from Baseline based on Redness Scoring using Oculus Keratograph-5 Machine at 8th week of eyedrop instillation.
Comparison of change in basal tear production in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 4th week of treatment
Change of basal tear production (mm) from Baseline through Schirmer's test at 4th week of eyedrop instillation.
Comparison of change in basal tear production in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 8th week of treatment
Change of basal tear production (mm) from Baseline through Schirmer's test at 8th week of eyedrop instillation.
Comparison of dry eye symptom improvements in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 4th week of treatment
Change of dry eye symptoms from baseline based on Ocular Surface Disease Index (OSDI) score at 4th week of eyedrop instillation.
Comparison of dry eye symptom improvements in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops
Time frame: At 8th week of treatment
Change of dry eye symptoms from baseline based on Ocular Surface Disease Index (OSDI) score at 8th week of eyedrop instillation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2020.
- Background: PubMed 8565190Lemp 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan Haslina Wan Abdul Halim, M.D(UKM) study chair
National University of Malaysia
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Optive, Ophthalmic Solution, Umbilical Cord Serum eye drops and Genteal lubricant gel in people with Dry Eye Syndromes, run by National University of Malaysia at 3 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wan Haslina Wan Abdul Halim, M.D(UKM) (+6019-6679633, afifiyad@yahoo.co.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of change in corneal surface in patients treated with Umbilical Cord Serum eyedrops and conventional AT eyedrops (time frame: At 4th week of treatment). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04217785, which also lists 39 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2020.