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

NCT06752278 | Completed DMC

• 1 other identifier: Pilocarpine and Dry Eye
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Disease (DED)

Outcome Measures

Primary Outcomes (2)

• Ocular Surface Disease Index

  At the baseline and after 6 weeks

• tear film break-up time

  At the baseline and after 6 weeks

Study Arms (2)

pilocarpine group

ACTIVE COMPARATOR

Drug: Pilocarpine

artificial tears group

ACTIVE COMPARATOR

Drug: artificial tears

Interventions

Pilocarpine DRUG

Pilocarpine is a muscarinic agonist

pilocarpine group

artificial tears DRUG

artificial tears used for the treatment of Dry eye

artificial tears group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with DED

You may not qualify if:

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

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Al-Azhar university

Damietta, Egypt

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Interventions

Pilocarpine; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal Investigator

Study Record Dates

• First Submitted: December 27, 2024
• First Posted: December 30, 2024
• Study Start: October 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 20, 2024
• Last Updated: December 30, 2024

Record last verified: 2024-12

Locations

EG (1)