A post market clinical follow up prospective study to evaluate safety and performance of Sodium Hyaluronate Ophthalmic Solution
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The primary objective will be, to confirm clinical safety and performance of the product Sodium
研究概览
简要总结
This study will be an open-label, single-armed, single-centric, observational, prospective PMCF study. The subjects visiting the study center with the complaints such as eye dryness, eye soreness/ burning, irritative sensation and discomfort of eyes due to the continuous use of computer/ TV/ exposed pollution/ dry environment will be screened on Day 0 and if they meet the inclusion and exclusion criteria, then they will be selected for the study. A total of 61 subjects will be recruited for this study, subjects will be undergoing visual acuity test, IOP, corneal staining, Superficial Keratitis, TBUT test, Schirmer’s test. After the consent is signed these subjects will be given. The allocation of Sodium Hyaluronate Ophthalmic Solution will be subjected to eye dryness by the PI. They will be followed up 3 times on Day 15, Day 30 and Day 60 after using the product. At every follow up visit the above-mentioned test, comprehensive eye examination by the Investigator will be performed and apart from these performance and safety tests, benefits, risks, side effects and adverse events will be recorded.
Results-
This observational, prospective, single-arm, single-center PMCF study evaluated the safety, performance, and clinical benefits of Sodium Hyaluronate Ophthalmic Solution in 61 subjects over 60 days. All subjects completed three follow-ups, with no adverse events, side effects, residual risks, contraindications, or off-label use reported. Corneal staining remained normal, superficial keratitis was absent, and intraocular pressure and visual acuity stayed within normal ranges, confirming safety. Schirmer’s test values improved (from 17.13/18.3 mm to 25.05/26.62), and TBUT scores increased (from 5.69/5.74 to 8.11/8.44), demonstrating enhanced tear production and tear film stability. Most participants reported relief from dryness (53), burning (59), soreness/irritation (59), and improved comfort during screen use (57), with benefits lasting over two hours. Both PI and subjects rated product performance as good to excellent, with universal satisfaction. Overall, the product proved safe, effective, and well-tolerated, offering moisturizing, soothing, and refreshing benefits without compromising visual quality
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who are able to give voluntary, written informed consent to participate in this study.
- •Subjects who experience eye dryness, eye soreness/ burning, irritative sensation and discomfort of eyes due to the continuous use of computer/ TV/ exposed pollution/ dry environment.
排除标准
- •Anyone with known allergic reaction to Sodium Hyaluronate Ophthalmic Solution.
- •Subjects with existing eye infection.
- •History of ocular surgery.
- •History or active signs of severe or serious ocular conditions such as inflammatory corneal ulcers, recurrent erosions, and uveitis at any time.
- •Patients participating in any another clinical trial during study.
结局指标
主要结局
The primary objective will be, to confirm clinical safety and performance of the product Sodium
时间窗: 1st Visit - After 15 days of using the product | 2nd Visit - After one month of using the product | 3rd Visit - After two months of using the product
Hyaluronate Ophthalmic Solution from the baseline with follow up visits.
时间窗: 1st Visit - After 15 days of using the product | 2nd Visit - After one month of using the product | 3rd Visit - After two months of using the product
次要结局
- The secondary objective will be to assess clinical benefits, contraindications and possible misuse/ off-label(use during the use of the product. Also, the continued acceptability of benefit-risk ratio will be ensured)
研究者
Dr S Prasannaraj
Sabhari Eye Care Hospital and Retina Centre