Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 and non-phase interventional studies have evaluated hypromellose in ophthalmology and oral drug delivery formulations. Sponsored by academic institutions and pharmaceutical corporations, these largely completed investigations address conditions such as dry eye disease, glaucoma, adenoviral keratoconjunctivitis, gastric ulcers, and viral respiratory infections including SARS-CoV-2. Overall, they assess the safety, bioavailability, and therapeutic efficacy of hypromellose as a lubricating agent, ocular surface barrier, or sustained-release drug matrix.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT05660447 UNKNOWN
Rhegmatogenous Retinal Detachment; Proliferative Vitreoretinopathy
Wills Eye
 2023-02-06 PHASE2; PHASE3
NCT05577910 COMPLETED
Meibomian Gland Dysfunction
Chinese University of Hong Kong
 2022-10-08
NCT05470868 COMPLETED
Hyperemia Eye
Laboratorios Sophia S.A de C.V.
 2023-02-04 PHASE1
NCT05825599 Completed
Dry Eye|Dry Eye Disease|Kerato Conjunctivitis Sicca
C.O.C. Farmaceutici S.r.l.
 2022-09-06 Not Applicable
NCT05358873 COMPLETED
SARS CoV 2 Infection; SARS-CoV-2 Acute Respiratory Disease
Chulalongkorn University
 2022-04-20
NCT04541888 COMPLETED
Dry Eye
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
 2020-11-05 PHASE3
NCT04970329 UNKNOWN
Dry Eye Disease
University of Faisalabad
 2021-07
NCT04868175 COMPLETED
Glaucoma; Intraocular Pressure
The University of Hong Kong
 2019-10-01
NCT02382588 TERMINATED
Herpes Zoster Keratitis
Northwestern University
 2013-12-10 PHASE2
NCT03676335 COMPLETED
Dry Eye
Zhaoke (Guangzhou) Ophthalmology Pharmaceutical Ltd.
 2018-05-09 PHASE2
NCT04020705 COMPLETED
Glaucoma
Istituto di Ricerca Neuroftalmologia S.r.l.
 2015-09-22
NCT02420834 COMPLETED
Dry Eye
Aston University
 2015-04
NCT01812044 COMPLETED
Strabismus
Duke University
 2013-03
NCT01533480 COMPLETED
Keratoconjunctivitis Due to Adenovirus; Viral Shedding
Lifelong Vision Foundation
 2012-01 PHASE4
NCT02097719 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2014-05 PHASE4
NCT01881126 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2013-06 PHASE4
NCT01964131 Completed
Gastric Ulcer|Duodenal Ulcer|Anastomotic Ulcer|Reflux Esophagitis|Etc.
AstraZeneca
 2013-10 Phase 1
NCT01525173 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2012-01 PHASE4
NCT01978015 COMPLETED
Uveitis, Anterior; Cystoid Macular Edema
University of Campinas, Brazil
 2011-10 PHASE4
NCT01340833 Completed
Cancer
GlaxoSmithKline
 2011-06-08 Phase 1
NCT01170884 COMPLETED
Glaucoma; Ocular Hypertension
Allergan
 2009-12 PHASE4
NCT00909324 COMPLETED
Dry Eye
Novartis Pharmaceuticals
 2009-08-01 PHASE4
NCT00598689 COMPLETED
Corneal Epithelium Defect
Augusta University
 2007-10 PHASE4

(data from https://clinicaltrials.gov, updated on 2024-07-30)

Check the Hypromellose product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Hypromellose functions as a hydrophilic polymer that physically binds water molecules to form a viscous, protective lubricating film across mucosal surfaces while swelling to form a controlled-release gel matrix in solid dosage forms. This hydration layer reduces surface friction and retards solute diffusion, thereby stabilizing the precorneal tear film to relieve ocular dryness in conditions like dry eye disease and prolonging active drug absorption in gastrointestinal therapeutics.

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.