Health Condition 1: H028- Other specified disorders of eyelid
Conditions
Interventions
Intervention1: Maquiday: 60 mg
Daily once
Oral dose
Helps in the treatment of patients with inflammatory dry eyes and fatigue
Control Intervention1: With standard treatment: For treating patients wit
Sponsors
G C Chemie Pharmie Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Subjects suffering from dry eyes Dry eye severity ranging from mild to sever grade 1 to 3 using the DEWS classification Playing video games use of PCs and or a mobile phone work at VDT for more than or equal to 4 hours per day Contact lens wearer who can discontinue lenses 24 hours prior to evaluation Subjects with normal lid position and closure Subjects willing to stop previous medication for dry eyes during study period Subjects willing to avoid use of natural eye lubricants on a daily basis but not morethan 6 times a day which has to be documented Subjects have to avoid the use of natural tears lubricant on the day of Schirmers test Subjects who have not participated in a similar investigation in the past four weeks Controlled diabetic patients with HBA1C limit less than 7 If using concomitant medications and the subject condition is stable the subject must agree to remain on a stable dose of his or her concomitant medications throughout the study period or if the subjects condition is not stable then they must agree not to use concomitant medications Voluntarily participating in the clinical study fully understanding and being fully informed of the study and having signed the Informed Consent Form willingness and capability to complete all the study procedures
Exclusion criteria
Exclusion criteria: Subjects who have used ophthalmic topical or systemic cyclosporine in the past 90 days. Subjects with Schirmer readings less than 2 mm/5 min without anesthesia in both eyes after stimulation thereby indicating end stage lacrimal gland disease. Subjects with active ocular infection or ocular inflammation due to autoimmune disease like Sjogrens disease etc Subjects with lipid-deficient dry eyes like Meibomitis or Meibomian gland disease Subjects with history of recurrent herpes keratitis or active disease within the last six months. Subjects with corneal disorder or abnormality that effects corneal sensitivity or normal spreading of the tear film. Subjects with severe blepharitis or obvious inflammation of the lid margin which in the judgment of the investigator may interfere with the interpretation of the study results. Subjects who had plug placement (laser, cautery, silicone, or collagen implant) within one month prior to the screening visit Subjects who use Pilocarpine or antihistamines more than 3 times a week Subject who have uncontrolled systemic disease (e.g., hypertension, diabetes) or the presence of any significant illness (e.g., serious gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiac, neurologic disease, cancer, AIDS, or cerebral dysfunction) that could in the judgment of the investigator interfere with interpretation of the study results
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of length of wetting of the Schrimer’s test strips after five minutes, providing mean value for left/right eye from Baseline to EOT Improvement in Dry eye condition between both the arms from baseline to EOT by DEQS Follow up will be done at 70 days +/- 3 days for the well-being of the patient. Timepoint: 70 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of Dry eye Eye fatigue level by VAS between both the arms from baseline to EOT Comparison of Tear Breakup time test from baseline to EOT between both the arms Improvement of dry eye symptoms from baseline to Day 30 & Day 30 to EOT between both the arms Monitoring for adverse events will be done throughout the study periodTimepoint: Day 30, 60 | — |
Countries
India
Contacts
Public ContactDr R Senthurselvi
Spinos Lifescience and Research Pvt Ltd
Outcome results
None listed