Clinical Trials

Numerous clinical trials ranging from Phase I through Phase IV evaluate methylcellulose and related polymer formulations for ocular conditions—including dry eye syndrome, keratoconus, corneal disease, conjunctivitis, and nasolacrimal duct obstruction—and systemic disorders such as diarrhea-dominant irritable bowel syndrome. Sponsored by academic medical centers, universities, and pharmaceutical companies, these investigations encompass completed, recruiting, terminated, and unknown recruitment statuses.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05999630 RECRUITING
Nasolacrimal Duct Obstruction; Thyroid Cancer
Vanderbilt University Medical Center
 2023-08-21 PHASE3
NCT07635849 NOT_YET_RECRUITING
Dry Eye Disease (DED)
Pokhara Academy of Health Sciences, Western Regional Hospital
 2026-07 PHASE4
NCT07523412 NOT_YET_RECRUITING
Peri-implant Bone and Soft Tissues
Ain Shams University
 2026-04-12 PHASE4
NCT07676084 RECRUITING
Dry Eye Disease (DED)
Andover Research Eye Institute
 2026-06-03 PHASE4
NCT07300137 ENROLLING_BY_INVITATION
Second Degree Burns
Patel Hospital, Pakistan
 2025-09-20
NCT06601101 RECRUITING
Keratoconus; Cornea Disease; Eye Diseases; Wound Heal
University of Campinas, Brazil
 2024-08-01 PHASE3
NCT06962462 NOT_YET_RECRUITING
Erectile Dysfunction Associated With Type 2 Diabetes Mellitus
South Valley University
 2025-05-05
NCT07194447 COMPLETED
Dental Implants , Osseointegration , Marginal Bone Loss , Implant Stability
Maha Zuhair
 2024-10-03
NCT06551961 RECRUITING
Irritable Bowel Syndrome
University of Nottingham
 2024-09-30
NCT04897503 UNKNOWN
Keratoconus; Corneal Ectasia
Cornea and Laser Eye Institute
 2021-04-16 PHASE3
NCT06514586 UNKNOWN
Vaginal Atrophy; Genitourinary Syndrome of Menopause; Vulvar Atrophy
Oxagon
 2024-09 PHASE3
NCT06911242 COMPLETED
Healthy Volunteer; Pharmacokinetics After Oral Intake
Arisan Therapeutics, Inc.
 2025-02-27 PHASE1
NCT06494137 UNKNOWN
Irritable Bowel Syndrome
University of Nottingham
 2024-10
NCT06726525 COMPLETED
Dry Eye
University of Milan
 2024-02-03 PHASE4
NCT06190054 UNKNOWN
Dry Eye Disease Associated to Asthenopia and Accommodative Effort in Video Display Terminal Users
Fidia Farmaceutici s.p.a.
 2023-02-06
NCT06551948 COMPLETED
Irritable Bowel Syndrome
University of Nottingham
 2024-01-01
NCT06291272 COMPLETED
Colon, Irritable
University of Nottingham
 2023-10-15
NCT05778266 COMPLETED
Metabolic Dysfunction-Associated Fatty Liver Disease; Obesity, Adolescent; Arterial Stiffness
Universidad de Guanajuato
 2023-03-14
NCT05911347 COMPLETED
Irritable Bowel Syndrome
University of Nottingham
 2023-05-09
NCT05063422 COMPLETED
Retentive Strength of Denture Adhesives
Altamash Institute of Dental Medicine
 2022-08-18 PHASE1
NCT05825599 COMPLETED
Dry Eye; Dry Eye Disease; Kerato Conjunctivitis Sicca
C.O.C. Farmaceutici S.r.l.
 2022-09-06
NCT04252209 COMPLETED
Sjogren's Syndrome; Xerostomia
Cairo University
 2021-03-22 PHASE3
NCT03484507 COMPLETED
Acanthamoeba Keratitis
University of California, San Francisco
 2018-01-01 PHASE2
NCT04654689 COMPLETED
Amyotrophic Lateral Sclerosis
Fundación Universidad Católica de Valencia San Vicente Mártir
 2021-11-20 PHASE2
NCT04474483 TERMINATED
COVID-19
State University of New York at Buffalo
 2020-11-06 PHASE2
NCT05924893 COMPLETED
Cornea Ulcer
Minia University
 2021-01-01
NCT05292755 COMPLETED
Dry Eye Syndromes
University of Florida
 2022-04-22 PHASE4
NCT05028907 COMPLETED
Ophthalmopathy , Lacrimal System
Sohag University
 2020-11-15 PHASE4
NCT03452891 COMPLETED
Periodontal Diseases
University of Nebraska
 2019-03-01 PHASE4
NCT01528800 COMPLETED
End-stage Kidney Disease
Dr. Rachel Holden
 2012-11 PHASE2
NCT02420834 COMPLETED
Dry Eye
Aston University
 2015-04
NCT04668859 TERMINATED
Use of Midodrine in Post-cardiopulmonary Bypass Vasoplegic Syndrome
Medstar Health Research Institute
 2016-07-29 PHASE4
NCT03418727 COMPLETED
Dry Eye
Ocugen
 2017-09-06 PHASE2
NCT02395952 WITHDRAWN
Cornea
Milton S. Hershey Medical Center
 2015-03
NCT02078648 COMPLETED
Adult Brain Glioblastoma; Glioblastoma Multiforme
Stemline Therapeutics, Inc.
 2014-05 PHASE1; PHASE2
NCT04542759 COMPLETED
Microbial Disease; Cataract Senile
Instituto de Oftalmología Fundación Conde de Valenciana
 2017-01 PHASE1
NCT01497951 COMPLETED
Leukoplakia; Lichen
Medical University of Vienna
 2011-05 PHASE3
NCT02883478 UNKNOWN
Keratoconus; Corneal Ectasia
Oslo University Hospital
 2012-08 PHASE1; PHASE2
NCT02544529 WITHDRAWN
Myopia
Danbury Eye Physicians & Surgeons, PC
 2016-06-01 PHASE4
NCT02557269 UNKNOWN
Seasonal Allergic Rhinitis
Association Asthma, Bulgaria
 2015-05 PHASE4
NCT02117687 COMPLETED
Dry Eye Syndromes; Keratoconjunctivitis Sicca
Allergan
 2014-05-14 PHASE4
NCT01532401 COMPLETED
Obesity
Poitiers University Hospital
 2011-03 PHASE2
NCT01036321 COMPLETED
Prostate Cancer
H. Lee Moffitt Cancer Center and Research Institute
 2009-12-11 PHASE2
NCT01986582 COMPLETED
Allergic Rhinitis
Association Asthma, Bulgaria
 2013-10 PHASE2
NCT02028754 COMPLETED
Dry Eye Syndromes; Cataract
Allergan
 2011-07 PHASE4
NCT01799863 COMPLETED
Conjunctivitis, Viral
Fundação Altino Ventura
 2012-06 PHASE2; PHASE3
NCT01732757 COMPLETED
Conjunctivitis, Allergic
Allergan
 2012-11 PHASE4
NCT01280110 COMPLETED
Dry Eye Syndromes
University of Campinas, Brazil
 2011-03 PHASE4
NCT01470118 COMPLETED
Conjunctivitis, Allergic
Allergan
 2011-10 PHASE4
NCT00934973 COMPLETED
Irritable Bowel Syndrome
Hazel Everitt
 2010-04 PHASE4
NCT00865540 UNKNOWN
Cataract
Clinica Oftamologica Zona Sul
 2009-03 PHASE4
NCT01282138 COMPLETED
Allergic Conjunctivitis
Alcon Research
 2010-12 PHASE4
NCT00987727 COMPLETED
Dry Eye Syndromes; Keratoconjunctivitis Sicca
Allergan
 2009-11 PHASE4
NCT01062204 COMPLETED
Partial-thickness Skin Donor Sites
ULURU Inc.
 2008-05
NCT00938704 COMPLETED
Dry Eye Syndromes
Allergan
 2009-06 PHASE4
NCT00485108 COMPLETED
Primary Open Angle Glaucoma; Pseudoexfoliation Glaucoma
Queen's University
 2007-01
NCT00809198 COMPLETED
Dry Eye
Alcon Research
 2008-12 PHASE4
NCT00544713 COMPLETED
Dry Eye Syndrome
Allergan
 2007-09
NCT00514852 COMPLETED
Dry Eye Syndrome
Allergan
 2007-10
NCT01738607 COMPLETED
Fecal Incontinence
University of Minnesota
 2004-04
NCT00243711 COMPLETED
Dry Eye
Allergan
 2005-09 PHASE2; PHASE3
NCT00543478 UNKNOWN
Irritable Bowel Syndrome
Aga Khan University
 2007-10 PHASE4
NCT00386646 COMPLETED
Dry Eye Syndromes
Chulalongkorn University
 2004-02 PHASE4
NCT01055925 COMPLETED
Reepithelialization of Skin Graft Donor Sites
Klinik Bogenhausen

(data from https://clinicaltrials.gov, updated on 2025-10-28)

Check the Methyl cellulose (Viscosity:100000mPa.s) product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

As a soluble hydrophilic polymer, methyl cellulose binds water to form a viscous, lubricating hydrogel matrix that stabilizes the precorneal tear film and reduces evaporation across mucosal membranes. This protective physical barrier diminishes mechanical friction and cellular stress on the corneal epithelium, providing therapeutic relief and promoting mucosal surface recovery in clinical conditions such as dry eye syndromes and keratoconus.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.