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临床试验/NCT00755183
NCT00755183已完成2 期

A Single-Center, Double-Masked, Randomized, Vehicle Controlled Study to Evaluate the Safety and Efficacy of Testosterone 0.03% Ophthalmic Solution Compared to Vehicle for the Treatment of Meibomian Gland Dysfunction

ORA, Inc.1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2008年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Meibomian Gland Secretion Appearance at Visit 4 (Day 168)

研究概览

简要总结

The objective of this study is to assess the safety and efficacy of testosterone 0.03% ophthalmic solution compared to vehicle for the treatment of meibomian gland dysfunction.

详细描述

Meibomian gland secretion plays a crucial role in the health of the ocular surface and function of the tear film. The lipid secreted by the meibomian glands has many crucial roles: 1) to retard evaporation from the preocular surface; 2) lower the surface tension of tears; 3) prevent spill-over of tears from the lid margin; 4) prevent the contamination of the tear film by sebaceous lipids; 5) prevent damage to the skin of the lid margin. In dry eye syndrome, blepharitis, meibomian gland dysfunction, and meibomitis the glands are the central pathophysiology of disease and thus a potential target for 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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

testosterone ophthalmic solution

Experimental

testosterone ophthalmic solution 0.03%

干预措施: testosterone ophthalmic solution (Drug)

vehicle

Placebo Comparator

vehicle of testosterone ophthalmic solution

干预措施: vehicle of testosterone ophthalmic solution (Drug)

结局指标

主要结局

Meibomian Gland Secretion Appearance at Visit 4 (Day 168)

时间窗: 168 days

The average of the secretion color, quality, and viscosity of the worst gland in the worst eye. All scales were numerical analog, 0-3, where 0=normal and 3=worst.

Ocular Discomfort Score at Visit 4

时间窗: 168 days

Ocular Discomfort Score on a 0-4 scale where 0=none and 4=constant discomfort at Visit 4 (Day 168)

次要结局

未报告次要终点

研究者

发起方
ORA, Inc.
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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