Health Condition 1: H578- Other specified disorders of eye and adnexa
Conditions
Interventions
None listed
Sponsors
Nil
Eligibility
Inclusion criteria
Inclusion criteria: Participants aged 15 to 45 years irrespective of gender. Willing to participate in the study by giving written informed consent or Assent. Corrected distance visual acuity of at least 6 by 9 Snellen equivalent in each eye Subjects included in the study will have, Dry eye symptoms as per OSDI score more than or equal to 13 and less than 32 at baseline along with Presence of any one of the following two tear homeostasis marker tests such as Three consecutive TBUT tests less than 10 sec in at least one eye or Ocular surface staining with fluoresceine staining in more than 5 corneal spots or more than 9 conjunctival spots or lid margin more than 2 mm length or more than 25% width in at least one eye with Lissamine staining
Exclusion criteria
Exclusion criteria: Individual who are unfit for pratimarsa nasya Schirmer test (with anaesthesia) less than or equal to 2 mm in either eye at screening Total corneal staining score of more than 10 or Corneal staining in any area has a score of 3 at screening or baseline. Pregnant or nursing woman Active or chronic systemic disease or autoimmune disease that influences Dry eye Subjects with behavioral habits such as smoking or Alcohol consumption or poor sleep Subjects who are hypersensitive to the study drug Use of any systemic medication that may affect tear film or vision such as steroids or immunosuppressants or parasympathomimetic agents or antihistamines or anxiolytics or diuretics or systemic hormones or antidepressants or Isotretinoin for less than 3 months before screening Current or previous use of topical ocular medications within 2 weeks of screening and intraocular pressure lowering agents for glaucoma less than 3 months before screening Ocular surgery or clinically significant trauma within 6 months prior to screening Use of contact lens or punctual plugs anticipated during the study Lid abnormalities such as ectropion or paralysis or Graves eye disease or Misdirected lashes or Ocular surface tumors or too much-elevated pterygium or pinguecula or chemical or thermal burns Actively chronic or acute infections such as conjunctivitis or keratitis or Uveitis or blepharitis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PRIMARY OUTCOME- OCULAR SURFACE DISEASE INDEX(OSDI) SCORETimepoint: base line screening, 8th day, 15th day, 22nd day, 31st day and in the follow up after 15 days and one month of the completion of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| PRIMARY OUTCOME- OCULAR SURFACE DISEASE INDEX(OSDI) SCORE SECONDARY OUTCOME Subject-reported symptoms/outcomes measured using a visual analogue scale (VAS), ranging from 0 to 10 Schirmer test ( with and without anaesthesia) Tear film break up time ( measured three times in each eye) Conjunctival and corneal staining patterns (modified NEI Grid score ) Meibomian gland functions Visual Acuity LogMar Chart Tear meniscus height. 8-question tolerability Timepoint: Screening ,8th , 15th, 22nd,31st and follow up, 15 and 30 days after the completion / withdrawal of the treatment. | — |
Countries
India
Contacts
Public ContactDr Ambili K
Government Ayurveda college, Thiruvananthapuram, Kerala
Outcome results
None listed