Health Condition 1: H041- Other disorders of lacrimal gland
Conditions
Interventions
Intervention1: Systane Ultra: Administering to the patient
Intervention2: Polyethylene Glycol: 2 drops in each eye ,4 times a day and for 30 days. Route of Administration: Topical
Control Intervention
Sponsors
Dr Agarwals eye hospital
Eligibility
Inclusion criteria
Inclusion criteria: . Male/female of >=18 and 2. Participant who can and willing to provide written Informed Consent 3. Participant more prone to computer use â?? daily computer / visual display unit (VDU) use > 3 hours per day /15 hours per week 4. Participant with minimum 3 months exposure to any VDU 5. Participant with CVS-Q score >= 6 6. Participant with OSDI Score 23-32 (both inclusive) with dry eye symptoms 7. Participant with TBUT 8. Participant is nonsmoker 9. Participant/ patientâ??s legally acceptable representative having an ability to understand the disease and its treatment and follow protocol requirements
Exclusion criteria
Exclusion criteria: 1. Participants Ë? 18 or Ë? 45 years of age 2. Participants using contact lenses within last 6 months 3. Participants having a history of systemic disease, other ocular pathologies or on prior treatment for the same 4. Participants with a history of intra or extraocular surgery or planning to undergo ocular or eyelid surgery 5. Participants taking previous treatment with steroids, isotretinoin or immunosuppressive drugs 6. Patient with any other clinically significant illness 7. Patient who has participated in another trial with an investigational drug within 6 months prior to this trial. 8. Patient with any other condition, which as per the investigator would jeopardize the outcome of the trial 9. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of Systane® lubricant eye drops on dryness symptoms as assessed by OSDI score in adult humans with patients with computer vision syndromeTimepoint: e from Visit 1, Screening/ Baseline Visit (Day 0) to Visit 3, End of Study Visit (Day 30 ± 2 days) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To evaluate the effect of Systane® lubricant eye drops on dryness symptoms as assessed by TBUT,CVS-Q score in adult humans with patients with computer vision syndrome 2. To assess safety of Systane® lubricant eye dropsTimepoint: 1. Mean change is TBUT,CVS-Q score from Visit 1, Screening/ Baseline Visit (Day 0) to Visit 3, End of Study Visit (Day 30 ± 2 days) 2. Number of Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE) | — |
Countries
India
Contacts
Public ContactDr Ashvin Agarwal
Dr. Agarwals Eye Hospital
Outcome results
None listed