Topical Statin Eye Drop in the Management of the Dry Eye

NCT06208384 | Unknown Phase 1

• 1 other identifier: 14023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

In the first stage, to evaluate the safety of the topical medication produced by Sina Pharmaceuticals, this medication is experimentally tested on 10 volunteer patients. If no side effects occur, eligible patients are enrolled in the study after examination by a specialist. The second stage is a randomized, double-blind clinical trial, during which selected patients are randomly assigned to the control and intervention groups. For patients in the intervention group, in addition to standard treatment, including eyelid hygiene and the use of artificial tears, a topical drop of Atorvastatin (50 microM) will be administered, one drop eight times a day in both eyes. In the control group, a placebo will be used in the same manner. The patients will be unaware of their assigned group. Clinical examinations, including Schirmer's test, tear breakup time, fluorescein staining, and completion of the dry eye syndrome questionnaire and dry eye questionnaire, will be conducted before and after the intervention to assess the level of eye dryness.

Conditions

Dry Eye Disease

Outcome Measures

Primary Outcomes (3)

• Change from tear break up time at week 4 follow up

  Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 4 follow up after completion of prescription period (8 week)

  Baseline and week 4 follow up

• Change from tear break up time at week 8 follow up

  Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 8 follow up after completion of prescription period (8 week)

  Baseline and week 8 follow up

• Change from tear break up time at week 12 follow up

  Time taken for the first dry spot to appear on the cornea after a complete blink will be assessed by slit lamp at baseline and week 12 follow up after completion of prescription period (8 week)

  Baseline and week 12 follow up

Secondary Outcomes (6)

• Change from Ocular Surface Disease Index at week 4 follow up

  Baseline and week 4 follow up

• Change from Ocular Surface Disease Index at week 8 follow up

  Baseline and week 8 follow up

• Change from Ocular Surface Disease Index at week 12 follow up

  Baseline and week 12 follow up

• Change from dry eye score at week 4 follow up

  Baseline and week 4 follow up

• Change from dry eye score at week 8 follow up

  Baseline and week 8 follow up

Study Arms (2)

Statin eye drop

EXPERIMENTAL

Use of topical atorvastatin eye drop 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)

Drug: Statin eye drop

Control

PLACEBO COMPARATOR

Use of topical eye drops as a placebo same as intervention group but without active ingredient of atorvastatin 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)

Drug: Placebo

Interventions

Statin eye drop DRUG

Use of topical atorvastatin eye 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)

Also known as: Tiam Darou

Statin eye drop

Placebo DRUG

Use of topical eye drops as a placebo same as intervention group but without active ingredient of atorvastatin 8 times a day; in addition to eyelid hygiene and artificial tear drops (8 weeks)

Also known as: Tiam Darou

Control

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>20 years old
• Dry eye induced by Meibomian gland dysfunction
• Tear break up time less than 10 seconds

You may not qualify if:

• Hematologic disorders
• Coagulopathies
• Use of anticoagulant medication
• Use of Peptic ulcer disease
• History of ocular surgeries in the last 3 months
• History of any ocular Malignancies
• History of ocular trauma
• History of statin use

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Kiana Hassanpour

  Ophthalmic Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Ophthalmic Research Center

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 17, 2024
• Study Start: January 4, 2024
• Primary Completion: January 4, 2025
• Study Completion: February 4, 2025
• Last Updated: January 17, 2024

Record last verified: 2024-01

Locations

IR (1)