Non Inferiority Phase IV Clinical Study, to Compare the Efficacy of the Ophthalmic Solution Humylub Ofteno® PF Against Hyabak® and Lagricel Ofteno® PF When Applied on the Ocular Surface of Patients With Mild to Moderate Dry Eye.
概览
- 阶段
- 4 期
- 干预措施
- Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%
- 疾病 / 适应症
- Dry Eye
- 发起方
- Laboratorios Sophia S.A de C.V.
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- Change in Ocular Surface Disease Index (OSDI)
- 状态
- 已完成
- 最后更新
- 2个月前
概览
简要总结
Phase IV, non inferiority, controlled, open, multicenter clinical study to compare the efficacy of the Ophthalmic Solution Humylub Ofteno® PF against Hyabak® and Lagricel Ofteno® PF applied quater in die (QID) for 30 days in patients with mild to moderate dry eye disease.
研究者
入排标准
入选标准
- •Being capable of voluntarily grant a signed informed consent.
- •Being willing and able to meet the requirements of the study such as attending programmed visits, treatment plan and other study procedures.
- •Age ≥ 18 years old
- •Women in child-bearing age must assure the continuation (start ≥ 30 days prior to informed consent signing) of a hormonal contraceptive method or intrauterine device (IUD) during the study.
- •Presenting a mild to moderate dry eye disease diagnosis, defined as:
- •OSDI score ≥ 13, plus one of the following:
- •More than 5 dots of corneal staining
- •More than 9 dots of conjunctival staining
- •Tear break-up time \< 10 seconds
排除标准
- •\- Pregnancy, breastfeeding or planning to become pregnant during the time of the study
- •Having participated in clinical trials within 30 days prior to the eligibility visit.
- •Having participated previously in this study.
- •BCVA equal or worse than 20/200, in either eye.
- •Diagnosis of any of the following:
- •Allergic, viral or bacterial conjunctivitis
- •Anterior blepharitis
- •Parasite infestation of any ocular or annex structures (Demodex, for example)
- •Unresolved history of ocular trauma
- •Scarring diseases of the ocular surface
研究组 & 干预措施
Arm 1; Humylub Ofteno® PF
Humylub Ofteno® PF (sodium hyaluronate 0.1%/chondroitin sulfate 0.18%) ophthalmic solution applied QID for 30 days.
干预措施: Sodium hyaluronate 0.1%/chondroitin sulfate 0.18%
Arm 2; Hyabak®
Hyabak® PF (sodium hyaluronate 0.15%) ophthalmic solution applied QID for 30 days.
干预措施: Sodium hyaluronate 0.15%
Arm 3; Lagricel Ofteno® PF
Lagricel Ofteno® PF (sodium hyaluronate 0.4%) ophthalmic solution applied QID for 30 days.
干预措施: Sodium hyaluronate 0.4%
结局指标
主要结局
Change in Ocular Surface Disease Index (OSDI)
时间窗: Days: 0 (± 2) (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).
OSDI is a 12-item questionnaire used to evaluate symptoms associated with dry eye disease, as well as classify their severity. According the obtained score, categories are as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). A higher score is a worse outcome. • This outcome measure considered the Per Protocol (PP) population.
次要结局
- Noninvasive Keratograph Break-up Time (NIKBUT)(Days: 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
- Change of Conjunctival and Corneal Staining With Lissamine Green(Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
- Change of Conjunctival and Corneal Staining With Fluorescein(Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
- Change in Conjunctival Hyperemia(Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
- Incidence of Related Non Expected Adverse Events(Days: 0 (eligibility visit), 0 - 2 (baseline visit),17 - 19 (± 1) (first follow-up visit), 31 - 33 (± 1) (final visit), and 38 - 40 (± 1) (safety call).)
- Change in Best Corrected Visual Acuity (BCVA)(Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)
- Change in Incidence of Chemosis(Days: 0 (eligibility visit), 17 - 19 (± 1) (first follow-up visit), and 31 - 33 (± 1) (final visit).)