To Assess the safety snd Effectiveness of Systane Ultra drops with dry eye due to Computer Vision Syndrome (CVS)

Phase 4

• Conditions: Health Condition 1: H041- Other disorders of lacrimal gland

• Registration Number: CTRI/2023/01/048794
• Lead Sponsor: Dr Agarwals eye hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

. Male/female of >=18 and <=45 years of age

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 < 10 at the time of screening

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of Systane® <br/ ><br>lubricant eye drops on dryness symptoms <br/ ><br>as assessed by OSDI score in adult <br/ ><br>humans with patients with computer <br/ ><br>vision syndromeTimepoint: e from Visit 1, <br/ ><br>Screening/ Baseline Visit (Day 0) to Visit 3, End <br/ ><br>of Study Visit (Day 30 ± 2 days) <br/ ><br>

Secondary Outcome Measures

Name	Time	Method
1. To evaluate the effect of Systane® <br/ ><br>lubricant eye drops on dryness symptoms <br/ ><br>as assessed by TBUT,CVS-Q score in <br/ ><br>adult humans with patients with computer <br/ ><br>vision syndrome <br/ ><br>2. To assess safety of Systane® lubricant eye <br/ ><br>dropsTimepoint: 1. Mean change is TBUT,CVS-Q score from Visit <br/ ><br>1, Screening/ Baseline Visit (Day 0) to Visit 3, End <br/ ><br>of Study Visit (Day 30 ± 2 days) <br/ ><br>2. Number of Treatment Emergent Adverse Event <br/ ><br>(TEAE) and Treatment Emergent Serious <br/ ><br>Adverse Event (TESAE) <br/ ><br>