NCT06913556

Brief Summary

In this research checked the curative effect of two different artificial tears on dry eyes after phacoemulsification was checked. In research, the randomized control trial methodology is used

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 20, 2025

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

March 29, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2025

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 20, 2026

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

3 months

First QC Date

March 29, 2025

Last Update Submit

March 29, 2025

Conditions

Dry Eye Syndrome

Outcome Measures

Primary Outcomes (2)

  • The Tear Break-Up Time (TBUT) test

    The Tear Break-Up Time (TBUT) test measures how long the tear film on the eye surface remains intact before it breaks up, with a normal TBUT typically being 10 seconds or more. A shorter TBUT suggests tear film instability and potential dry eye issues.

    12 Months

  • Schirmer test

    In a Schirmer test, a score of greater than 10 mm of moistened area on the filter paper after 5 minutes is considered normal, while less than 10 mm suggests dry eyes

    12 Months

Study Arms (2)

preoperative dry eyes

EXPERIMENTAL
Diagnostic Test: Preoperative dry eyes

lipid coated carbomer gel eye drops

EXPERIMENTAL
Combination Product: Lipid coated carbomer gel eye drops

Interventions

Preoperative dry eyesDIAGNOSTIC_TEST

In group 1 we access preoperative dry eyes condition and postoperatively we access the condition in 2nd and 4th week with the use of Hylorunic acid lubricant.

preoperative dry eyes
Lipid coated carbomer gel eye dropsCOMBINATION_PRODUCT

In group 2 we prescribe the lipid coated carbomer gel eye drops and access dry eyes condition preoperative and postoperative on 2nd and 4th week and check the curative effect of drop.

lipid coated carbomer gel eye drops

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 50-70
  • Both gender male /female

You may not qualify if:

  • Patients who have acute 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, 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 29, 2025

First Posted

April 6, 2025

Study Start

March 20, 2025

Primary Completion

June 20, 2025

Study Completion

February 20, 2026

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)