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Clinical Trials/CTRI/2018/01/011121
CTRI/2018/01/011121
Completed
Phase 4

Analysis of comparative efficacy of a combination formula for a lubricant (Trehalose with sodium hyaluronate 1mg/mL) in the management of ocular surface conditions

arayana Nethralaya0 sites0 target enrollmentTBD

Overview

Phase
Phase 4
Intervention
Not specified
Conditions
Health Condition 1: null- Mild to moderate dry eye diseaseHealth Condition 2: H100- Mucopurulent conjunctivitis
Sponsor
arayana Nethralaya
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
arayana Nethralaya

Eligibility Criteria

Inclusion Criteria

  • 1\.Males and Females
  • 2\.Age 18 to 65 years,
  • 3\.Mild to moderate dry eye disease as per:
  • i.OSDI score \>18
  • ii.Schirmers II (with anaesthesia) \>5 at 5 minutes, \< 10 at 5 minutes
  • iii.TBUT \< 7 seconds
  • iv.Corneal and conjunctival staining ( graded
  • by NEI and Van Bjisterveld grading)
  • 4\.No use of any tear substitute for either eye in the preceding 6 weeks
  • 5\.Willing to participate in the study

Exclusion Criteria

  • 1\.BCVA distance \< 6/60
  • 2\.Severe blepharitis
  • 3\.Eyelid malposition
  • 4\.Corneal scar/ opacity
  • 5\.Ocular Surface Squamous neoplasia (OSSN)
  • 6\.Corneal neovascularisation or pannus
  • 7\.cular allergy (except in paediatric population)
  • 8\.Any ocular infection in the past 3 months
  • 9\.Cataract surgery in the past 3 months
  • 10\.Corneal or conjunctival procedure

Outcomes

Primary Outcomes

Not specified

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