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临床试验/NCT03480295
NCT03480295已完成不适用

Exploring the Effects of a Preservative-free Ophthalmic Solution Containing Hyaluronic Acid 0.4% and Taurine 0.5% on the Ocular Surface of Glaucoma Patients Under Multiple Long-term Topical Hypotensive Therapy

Fondazione G.B. Bietti, IRCCS0 个研究点目标入组 39 人开始时间: 2016年12月19日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
39
主要终点
Change from baseline of conjunctival goblet cells (CGC) density after 30 and 90 days

研究概览

简要总结

Eligible patients underwent evaluation of ocular surface parameters by Ocular Surface Disease Index (OSDI) and Glaucoma Symptom Scale (GSS) questionnaires, Break Up Time test (BUT), Schirmer I test, corneal and conjunctival staining (Oxford scale) and conjunctival in vivo confocal microscopy (Heidelberg Retina Tomograph 3, Heidelberg Engineering Gmbh, Heidelberg, Germany). After the baseline visit, patients were randomized to use a PF ophthalmic solution containing HA 0.4% and TAU 0.5%, QID, in both eyes (Group 1) or to use a PF ophthalmic solution containing HA 0.2%, QID, (Group 2) in addition to the ongoing preserved hypotensive treatment. Follow-up visits were scheduled at 30 and 90 days.

详细描述

At the screening visit all patients underwent comprehensive ophthalmological examination including best corrected visual acuity assessment, slit lamp evaluation, IOP measurement using Goldmann applanation tonometry, and indirect dilated ophthalmoscopy with a 90 diopters lens. Visual field testing using Humphrey 24-2 SITA-Standard program (Carl Zeiss Meditec, Inc., Dublin, CA 24-2 program) was performed only for those patients with the last exam older than 3 months.

Baseline visit was splitted in two visits scheduled 1 week apart 2 days, to evaluate ocular surface alterations by means of several tests.

To minimize the influence of each test on the subsequent test, we performed first the least invasive and then the most invasive test. During the first baseline visit patients were asked to fill two questionnaires, the Ocular Surface Disease Index (OSDI) and the Glaucoma Symptom Scale (GSS) and then underwent the Break Up Time test (BUT), corneal and conjunctival staining evaluation using Oxford Staining Scheme, and Schirmer I test after 15 minutes of rest. During the second baseline visit, patients underwent conjunctival Confocal Laser Microscopy with the Rostock Module of Cornea of the Heidelberg Retina Tomograph (HRT3, Heidelberg Engineering Gmbh, Heidelberg, Germany).

At the end of the second baseline visit patients were randomized in two groups with a 1:1 ratio according to a computer-generated randomization list.

Group 1 (HA0.4%+TAU0.5%) was asked to self-administer 1 drop four times/day of a preservative-free ophthalmic solution containing 750KDa HA 0.4% and TAU 0.5% in both eyes, while Group 2 (HA0.2%) was asked to self-administer 1 drop four times/day of a preservative-free ophthalmic solution containing only 750KDa HA 0.2%, in addition to the ongoing hypotensive therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of glaucoma with an ongoing topical therapy with two or more preserved ocular hypotensive eye-drops per day for at least two years.

排除标准

  • Best corrected visual acuity ≤ 20/40
  • History of active or past ophthalmological diseases different than glaucoma
  • Contraindications to use of topical solution components used in this study
  • Current use of contact lenses
  • Current use or use in the past 6 months of ocular medications other than hypotensive eye-drops
  • Systemic treatments known to affect tear secretion
  • Any history or slit lamp evidence of eye surface diseases different from dry eye
  • History of ocular trauma
  • Surgery or laser treatments
  • Rheumatologic and autoimmune diseases
  • Peripheral neuropathies
  • Use of systemic steroids or immunosuppressants

研究组 & 干预措施

HA0.4%+TAU0.5%

Experimental

Patients had to administer 4 drops/day of an ophthalmic solution containing hyaluronic acid 0.4% and taurine 0.5% in addition to the ongoing glaucoma treatment

干预措施: Hyaluronic acid 0.4% and Taurine 0.5% (Device)

HA0.2%

Active Comparator

Patients took 4 drops/day of an ophthalmic solution containing hyaluronic acid 0.2%

干预措施: Hyaluronic acid 0.2% (Device)

结局指标

主要结局

Change from baseline of conjunctival goblet cells (CGC) density after 30 and 90 days

时间窗: Baseline, 30 and 60 days

Density of CGC was measured by means of conjunctival confocal microscopy

次要结局

未报告次要终点

研究者

发起方
Fondazione G.B. Bietti, IRCCS
申办方类型
Other
责任方
Sponsor

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