Evaluation of Treatment Efficacy, Safety and Tolerability of an Ayurvedic Ophthalmic Ointment (Pathyadi Varti Anjana) for Meibomian Gland Dysfunction and Associated Dry Eye: A Pilot Clinical Study
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- To determine the mean change in Total Ocular Surface Disease Index (OSDI) at the follow-up and after 2 months (last treatment visit) compared with baseline.
研究概览
简要总结
**Purpose:**To evaluate the treatment efficacy, safety, and tolerability of Pathyadi Varti ointment applied to the upper and lower eyelid once a day before bathing for up to 2 months compared to Moxifloxacin eye ointment (0.5%) in patients with meibomian gland dysfunction (MGD) and associated dry eye.
Design: Clinical, Prospective, Randomized, Open labelled, Parallel Group, Drug controlled, Single blind study.
Participants: (n=15) Patients of either gender, aged 18 years or older, diagnosed with meibomian gland dysfunction based on their medical history and eyelid examination. Severity grading will be conducted on the screening day using the Ocular Surface Disease Index (OSDI), the Standard Patient Evaluation of Eye Dryness (SPEED) questionnaire, and the Visual Analogue Scale (VAS).
Methods: Patients will be randomized in a 1:1 ratio to study treatment with Trial drug (Pathyadi Varti) or Control drug (Moxifloxacin Eye ointment 0.5%). Each enrolled subject will receive treatment for 2 months and will be followed for a total of 2.5 months, with evaluations conducted at baseline and on days 15, 30, 45, 60, and 75 after starting the study medication. Only one eye per patient will be randomly selected for evaluation, with preference given to the eye exhibiting a worse Ocular Surface Disease Index (OSDI), Standard Patient Evaluation of Eye Dryness (SPEED) score, and Visual Analogue Scale (VAS) score; if both eyes have equal scores, the right eye will be chosen. Study participants will complete the OSDI questionnaire, SPEED questionnaire, and VAS assessment at each visit. Tear Break-Up Time (TBUT) will be performed first to avoid potential interference from eyelid manipulation, with three successive readings averaged. Following a 30-minute wait, Schirmer’s test without anesthesia will be conducted with the patient’s eyes closed. TBUT, Schirmer’s test, and corneal fluorescein staining (CFS) will be performed at each visit.
Main outcome measures: The primary efficacy outcome will be to determine the mean change in the Total Ocular Surface Disease Index (OSDI) at follow-up and after 2 months (last treatment visit) compared with baseline. The secondary efficacy outcome will be to determine the mean change in tear break-up time (TBUT), Schirmer test, and fluorescein staining test at follow-up and the last treatment visit compared with baseline. Additionally, the mean change from baseline to follow-up and the last treatment visit in the Standard Patient Evaluation of Eye Dryness (SPEED) score and Visual Analogue Scale (VAS) will be assessed. Changes in eyelid appearance (normal versus abnormal) will also be evaluated using biomicroscopy with a slit lamp, including parameters such as lid margin thickening, conjunctival injection, loss of eyelashes, pouting, and plugging of meibomian gland orifices at follow-up and the last treatment visit compared with baseline. Furthermore, the tolerability and safety of the Ayurvedic intervention (Pathyadi Varti Anjana) will be assessed.
Results: Both groups will be compared on the basis of main outcome measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients who meet the following criteria will be selected for the study 1) Adult patients (aged 18 years or older) with a diagnosis of Meibomian Gland Dysfunction (MGD), ocular dryness, meibomian gland orifice plugging, lid margin telangiectasia. 2) Patients with MGD having Ocular Surface Disease Index (OSDI) scores of more than or equal to 13 at baseline and tear film breakup time (TBUT) of less than or equal to 10 seconds, Schirmer’s test less than or equal to 10mm in both eyes. 3) Score more than or equal to 6 on the Standard Patient Evaluation of Eye Dryness questionnaire (SPEED). 4) Prior to starting recruitment procedures, patients are required to have discontinued.
- •a) Use of systemic antihistamines or isotretinoin for at least 1 month. b) Anti-inflammatory treatments for DED for at least 3 months. c) All other prescription medications used for dry eye or MGD (e.g., antibiotics, corticosteroids, and non-steroidal anti-inflammatory) for at least 2 weeks. d) All other topical ophthalmic preparations (including artificial tear substitutes) other than the study medication: 72 hours prior to screening visit. 5) Patients able and willing to provide written informed consent and likely to complete the entire course of study according to instructions.
排除标准
- •Patients will be excluded from enrollment if they have 1) With pre-existing diseases causing dry eye (e.g., autoimmune diseases such as Sjogren syndrome, rheumatoid arthritis, lupus, Graves’ disease, and sarcoidosis), ocular infection or inflammation including conjunctivitis, keratitis, episcleritis, scleritis, dacryocystitis; punctual occlusion; lagophthalmos; ocular trauma; Stevens-Johnson syndrome.
- •Inflammatory diseases unrelated to MGD.
- •Patients suffering from any systemic disorder or taking any medications which in the opinion of Principle Investigator may affect the clinical outcome of the trial.
- •Use of topical steroids, topical cyclosporine, topical anti-glaucoma medication within 60 days before screening.
- •History of Contact lenses use.
- •History of ocular surgery within 6 months prior to enrolment in trial.
- •Chemical, thermal or radiation injury.
- •Ocular or periocular malignancy.
- •Lid structural abnormality not caused by MGD.
- •An active or recurring eye or eyelid infection or ocular surface abrasion.
- •Only one eye in each patient will be enrolled in the study.
- •If both eyes will be eligible, the right eye will be selected.
- •Patients who will unable to continue for the proposed length of treatment or return for follow-up visits.
- •Pregnant and lactating mother.
- •Active participation in any type of intervention study.
结局指标
主要结局
To determine the mean change in Total Ocular Surface Disease Index (OSDI) at the follow-up and after 2 months (last treatment visit) compared with baseline.
时间窗: day 15, day 30, day 45, day 60, and day 75
次要结局
- 1. To determine the mean change in tear break-up time (TBUT), Schirmer test and fluoresceine staining test at the follow-up and last treatment visits compared with baseline.(2. To determine the mean change from baseline to follow up and last treatment visit in Standard Patient Evaluation of Eye Dryness (SPEED) score and visual analog.)
研究者
Dr Rajiv Ranjan Mishra
Government Ayurvedic College and Hospital, Patna