Health Condition 1: H028- Other specified disorders of eyelid
Conditions
Interventions
None listed
Sponsors
Dr. Rajiv Ranjan Mishra
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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. 2) Inflammatory diseases unrelated to MGD. 3) 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. 4) Use of topical steroids, topical cyclosporine, topical anti-glaucoma medication within 60 days before screening. 5) History of Contact lenses use. 6) History of ocular surgery within 6 months prior to enrolment in trial. 7) Chemical, thermal or radiation injury. 8) Ocular or periocular malignancy. 9) Lid structural abnormality not caused by MGD. 10) An active or recurring eye or eyelid infection or ocular surface abrasion. 11) Only one eye in each patient will be enrolled in the study. If both eyes will be eligible, the right eye will be selected. 12) Patients who will unable to continue for the proposed length of treatment or return for follow-up visits. 13) Pregnant and lactating mother. 14) Active participation in any type of intervention study. 15) Patients who start developing complications.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.Timepoint: day 15, day 30, day 45, day 60, and day 75 | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. 3. To determine the change in eyelid appearance (Normal versus Abnormal) in biomicroscopy evaluation with the slit lamp, including lid margin thickening, conjunctival injection, loss of eye lashes, pouting and plugging of meibomian gland orifices at the follow-up and last treatment visit compared with baseline. 4. To determine the tolerability and safety of Ayurvedic intervention (Pathyadi Varti Anjana). Timepoint: day 15, day 30, day 45, day 60, and day 75 | — |
Countries
India
Contacts
Public ContactDr. Rajiv Ranjan Mishra
Government Ayurvedic College and Hospital, Patna
Outcome results
None listed