A clinical trial to study the effects of theSystane gel eye drops in the treatment of dryeye disease.

Not Applicable

• Conditions: Health Condition 1: H578- Other specified disorders of eye and adnexa

• Registration Number: CTRI/2021/01/030850
• Lead Sponsor: Alcon Laboratories Ind Pvt Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

(Healthy volunteers)

Inclusion criteria

1. Normal subjects with DEQ<=6 and TFBUT >=10 Sec

2. Male or female adults aged >18 years and <65 years of age

3. BCVA of >= 20/40 in each eye as measured

(Dry eye subjects)

1.Male or female adults aged >18 years and <65 years of age

2.DEQ-5 Score >= 6

3.TBUT <= 10 Seconds in both eyes

4.BCVA of >= 20/40 in each eye as

Exclusion Criteria

Healthy volunteers

1.Any history of Steven Johnson syndrome, Trachoma or Ocular Herpes simplex or Herpes zoster

2.History of scars in the cornea due to trauma, infection

3.History of infection or inflammation during the last 30 days

4.Corneal conditions other than dry eyes â?? dystrophy, epitheliopathies, pterygium, keratoconus

5.Post refractive surgeries

6.Post corneal transplant ( PK/LK/ DSEK/ DMEK etc)

7.Presence of punctal plugs or thermal cautery to the puncta

8.Lagophthalmos or Ptosis

9.Patients on Antiglaucoma medications.

10.Patient who are using systemic medications known to cause dry eyes

11.Patient who are on contact lens use

DRY EYE SUBJECTS

1.Any history of Steven Johnson syndrome, Trachoma or Ocular Herpes simplex or Herpes zoster

2.History of scars in the cornea due to trauma, infection

3.History of infection or inflammation during the last 30 days

4.Corneal conditions other than dry eyes â?? dystrophy, epitheliopathies, pterygium, keratoconus

5.Post refractive surgeries

6.Post corneal transplant ( PK/LK/ DSEK/ DMEK etc)

7.Presence of punctal plugs or thermal cautery to the puncta

8.Lagophthalmos or Ptosis

9.Patients on Antiglaucoma medications.

10.Patient who are using systemic medications known to cause dry eyes

11.Patient who are on contact lens use

Study & Design

• Study Type: Interventional
• Study Design: Not specified