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Multicenter clinical trial of recombinant bovine basic fibroblast growth factor (bFGF) gel in the treatment of moderate dry eye

Randomized,double blind and parallel controlled clinical trial of recombinant bovine basic fibroblast growth factor (bFGF) gel in the treatment of moderate dry eye

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-OPC-15006791
Enrollment
Unknown
Registered
2015-07-23
Start date
2015-07-27
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

dry eye

Interventions

Treatment group :bFGF gel Four times a day, every time a drop, 28 days
Control group:Substrate gel Four times a day, every time a drop, 28 days

Sponsors

Eye Institute of Xiamen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. participation in the clinical research, voluntary and sign a consent form; 2. gender unlimited, ages 18 to 75 years of age; 3. With clinical symptoms and signs of dry eye and clinical examination also conforms to: (1) One of the symptoms:dry sense, foreign body sensation, burning sensation, fatigue, discomfort, vision; (2) TBUT is less or equal than 10s but more than 0s,and Schirmer test I is from 2mm/5minutes to 5mm/5minutes; (3) Corneal fluorescein staining ? level:countable dot stain (without flake color fusion and filament); (4) Conjunctival fluorescein staining ? level:countable dot stain (without flake color fusion); 4. the study choice: patients' eyes are checked, for the signs and symptoms score high risk of eye eye; Such as integral equal, corneal fluorescein staining for the study of the heavier with eye, such as eyes fluorescein staining degree equal to take the right eye eye for research; 5. test in 3 months did not attend any other drug clinical trials; 6. don't use other medications, or use other drugs but has stopped for more than 2 weeks.

Exclusion criteria

Exclusion criteria: Every one of the following circumstances, not as the case: (1) the test allergy to any ingredient in the drug; (2) pregnant or lactating women or recently have fertility planners; (3) the clinical examination for fungi, bacteria, Angle, conjunctivitis in active patients; (4) with other conjunctiva, cornea and iris obvious pathological changes; (5) TBUT=0 s,or Schirmer Test<2mm/5minuts; (6) with serious heart, cerebrovascular, liver, kidney and hematopoietic system, severe primary disease; (7) nearly six months have eye surgery within or outside of the injured eye; (8) postmenopausal hormone replacement therapy; (9) lacrimal point embolism therapy nearly 1 month; (9) high intraocular pressure of patients with glaucoma or seen; (10) HSK infection history of patients; (11) may affect the outcome of treatment, such as systemic steroid hormones and immunosuppressive therapy); (12) experiments cannot stop wearing corneal contact lens; (13) patients with systemic or ocular long-term drug use may affect the research assessment; (14) during the test is no guarantee that drugs according to the requirements and with the visitor; (15) S'Sjoren syndrome, systemic disease and other ocular diseases that affect efficacy evaluation; (16) The researchers think there's any reason unsuitable for test in patients.

Design outcomes

Primary

MeasureTime frame
Conjunctival congestion degree;TBUT;Schirmer Test;Corneal staining scores;Conjunctival staining scores;

Secondary

MeasureTime frame
Goblet cell density;Cell karyoplasmic ratio;Squamous metaplasia;

Countries

China

Contacts

Public ContactZuguo Liu
zuguoliu@xmu.edu.cn+86 18959289999

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026