NCT06901895

Brief Summary

In this study we compare the curative effect of two lubricants Hylorunic acid and visol gel on dry eyes after phacoemulsification in diabetic patients. We check the tear film before operation and check post operate after 2nd week and 4th week of surgery. Its a hospital based study .

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2025

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

4 months

First QC Date

March 23, 2025

Last Update Submit

March 28, 2025

Conditions

Dry Eye

Outcome Measures

Primary Outcomes (2)

  • Schirmer test

    The Schirmer's test, also known as the Schirmer tear test, is a medical test used to assess tear production, particularly when a person experiences dry eyes or excessive tearing, by measuring how much a filter paper strip gets wet by tears in the lower eyelid

    12 Months

  • Tear Break up Test

    The Tear Breakup Time (TBUT) test, also known as the Tear Film Breakup Time (TFBUT) test, assesses tear film stability by measuring the time it takes for dry spots to appear on the cornea after a blink, indicating potential dry eye

    12 months

Study Arms (2)

Hylorunic acid

EXPERIMENTAL
Combination Product: Hylorunic acid

Lipid coated carbomer gel

ACTIVE COMPARATOR
Diagnostic Test: Lipid coated carbomer gel

Interventions

Hylorunic acidCOMBINATION_PRODUCT

Hylorunic acid (hylo) eye drop is prescribed and check the curative effect after phacoemulsification after 2nd and 4th week.

Hylorunic acid
Lipid coated carbomer gelDIAGNOSTIC_TEST

Lipid coated carbomer gel (visole)is prescribed and check yhe curative effect after phacoemulsification in diabetic patients post operatively in 2nd and 4th week.

Lipid coated carbomer gel

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who have acute dry eye condition before phacoemulsification cataract surgery.

You may not qualify if:

  • Patients who have chronic dry eye condition before phacoemulsification cataract surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaheen welfare hospital

Lahore, Punjab Province, 03155419544, Pakistan

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 23, 2025

First Posted

March 30, 2025

Study Start

March 20, 2025

Primary Completion

July 20, 2025

Study Completion

February 20, 2026

Last Updated

March 30, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)