Efficacy of Pilocarpine As a Secretagogue Versus Artificial Tears for the Treatment of Dry Eye

December 27, 2024 updated by: Ehab Tharwat, Al-Azhar University
Management approaches for dry eye disease (DED) typically start with low-risk, easily accessible, patient-applied therapies like artificial tears for early-stage disease. As the condition worsens, treatment progresses to more advanced therapies for severe forms of DED. This study aims to compare the effectiveness and safety of pilocarpine as a secretagogue versus artificial tears in the treatment of dry eye disease. Our goal is to provide reliable, high-quality evidence regarding the efficacy of secretagogues, thereby contributing to the development of recommendations that aid clinicians in their decision-making process

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Damietta, Egypt
        • Al-Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients diagnosed with DED

Exclusion Criteria:

  • Previous Occular surgery.
  • Refuse to particupate.
  • Patients with sjogren syndrome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: pilocarpine group
Drug: Pilocarpine
Pilocarpine is a muscarinic agonist
Active Comparator: artificial tears group
Drug: artificial tears
artificial tears used for the treatment of Dry eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Ocular Surface Disease Index
Time Frame: At the baseline and after 6 weeks
At the baseline and after 6 weeks
tear film break-up time
Time Frame: At the baseline and after 6 weeks
At the baseline and after 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

December 20, 2024

Study Registration Dates

First Submitted

December 27, 2024

First Submitted That Met QC Criteria

December 27, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 27, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pilocarpine and Dry Eye

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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