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Umbilical Cord Serum Versus Conventional Eyedrops

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04217785
Recruitment Status : Not yet recruiting
First Posted : January 3, 2020
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
Wan Haslina Wan Abdul Halim, National University of Malaysia

Brief 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 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.

Condition or disease Intervention/treatment Phase
Dry Eye Syndromes Drug: Optive, Ophthalmic Solution Biological: Umbilical Cord Serum eye drops Drug: Genteal lubricant gel Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Umbilical Cord Serum Versus Conventional Eyedrops In Treatment of Moderate To Severe Dry Eye Disease: A Randomized Clinical Trial
Estimated Study Start Date : January 6, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Active Comparator: A-AT eye drops
Optive Fusion UD eye drops + Genteal lubricant gel
Drug: Optive, Ophthalmic Solution
6 drops per day, for 8 weeks
Other Name: Optive Fusion UD

Drug: Genteal lubricant gel
Genteal lubricant gel (2 drops per day, for 8 weeks)

Active Comparator: B-UCS eye drops
UCS eye drops + GentTeal lubricant gel
Biological: Umbilical Cord Serum eye drops
UCS eye drops (6 drops per day, for 8 weeks)

Drug: Genteal lubricant gel
Genteal lubricant gel (2 drops per day, for 8 weeks)




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Exclusion Criteria:

  • Infective cases
  • Cases with limbal stem cells deficiency
  • Patients with lid abnormalities
  • Allergic to study eye drops component

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217785


Contacts
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Contact: Wan Haslina Wan Abdul Halim, M.D(UKM) +6019-6679633 afifiyad@yahoo.co.uk

Locations
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Malaysia
UKM Medical Centre
Cheras, Kuala Lumpur, Malaysia, 56000
Contact: Wan Haslina Wan Abdul Halim, M.D    +6019-6679633    afifiyad@yahoo.co.uk   
Principal Investigator: Wan Haslina Wan Abdul Halim, M.D         
Principal Investigator: Lim See Theng, M.D         
National Blood Centre, Malaysia
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50400
Hospital Kuala Lumpur
Kuala Lumpur, Wilayah Persekutuan, Malaysia, 50586
Contact: Rohanah Alias, M.D.    +014-9761507    drrohanah71@yahoo.com   
Sub-Investigator: Rohanah Alias, M.D.         
Sponsors and Collaborators
National University of Malaysia
Investigators
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Study Chair: Wan Haslina Wan Abdul Halim, M.D(UKM) National University of Malaysia
Publications of Results:
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.

Other Publications:
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.
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
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):

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Responsible Party: Wan Haslina Wan Abdul Halim, Consultant Ophthalmologist-Cornea And Anterior Segment, National University of Malaysia
ClinicalTrials.gov Identifier: NCT04217785    
Other Study ID Numbers: FF-2019-209
GGPM-2018-052 ( Other Grant/Funding Number: National University of Malaysia )
First Posted: January 3, 2020    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: January 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Wan Haslina Wan Abdul Halim, National University of Malaysia:
Umbilical Cord Serum Eyedrops
Moderate To Severe Dry Eye
Additional relevant MeSH terms:
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Keratoconjunctivitis Sicca
Dry Eye Syndromes
Keratoconjunctivitis
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Keratitis
Corneal Diseases
Lacrimal Apparatus Diseases
Ophthalmic Solutions
Pharmaceutical Solutions