Side Effects of Atropine (SEA) Study

NCT03593044 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2018H0224
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

This study will perform several objective and subjective measurements of the eye and vision before and after a week of using 0.01% concentration atropine drops. These measurements will help to obtain a comprehensive understanding of the side effects of this concentration of atropine and determine if the drops would be tolerated as a possible preventative treatment for nearsightedness.

Conditions

Myopia

Keywords

atropine; photophobia; pupil; reading speed; myopia; Surveys and Questionnaires

Outcome Measures

Primary Outcomes (2)

• Diameter of the Pupil Measured With a Neuroptix Pupillometer

  Change in pupil size between baseline visit and follow up visit (after one week on treatment) in millimeters to the nearest tenth of a millimeter

  Baseline (before) and one week after beginning treatment with drops

• Visual Acuity With Bailey-Lovie logMAR Visual Acuity Charts

  Investigators will measure the change in high contrast distance and near logMAR visual acuity and low contrast distance logMAR visual acuity between baseline visit and follow up visit (after one week on treatment).

  Baseline (before) and one week after beginning treatment with drops

Secondary Outcomes (4)

• Eye Focusing Measured by the Closest One Can Read a Letter and Focusing Accuracy Measured by an Autorefractor

  One week after beginning treatment with drops

• Change in Subjective Assessment of Potential Side Effects by Asking the Same Questions Before and After Administration of Eye Drops.

  Baseline (before) and one week after beginning treatment with drops

• Change in Intraocular Pressure Using a Tonopen

  Baseline (before) and one week after beginning treatment with drops

• Ability to Change Focus From Far to Near Measured by Stimulating and Relaxing Focus of the Eyes as Many Times as Possible in One Minute.

  Baseline (before) and one week after beginning treatment with drops

Study Arms (1)

One Week Atropine

EXPERIMENTAL

0.01% concentration atropine drops

Drug: 0.01% concentration atropine drops

Interventions

0.01% concentration atropine drops DRUG

One drop of 0.01% concentration atropine in each eye at night for seven days.

Also known as: Atropine Sulfate

One Week Atropine

Eligibility Criteria

• Age: 21 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• N/A

You may not qualify if:

• Outside of age range
• History of accommodative (focusing) issues or therapy

Sponsors & Collaborators

• Jeffrey J. Walline, OD PhD: lead

Study Sites (1)

Ohio State University College of Optometry

Columbus, Ohio, 43210, United States

Location

Related Publications (2)

• Chia A, Chua WH, Cheung YB, Wong WL, Lingham A, Fong A, Tan D. Atropine for the treatment of childhood myopia: safety and efficacy of 0.5%, 0.1%, and 0.01% doses (Atropine for the Treatment of Myopia 2). Ophthalmology. 2012 Feb;119(2):347-54. doi: 10.1016/j.ophtha.2011.07.031. Epub 2011 Oct 2.

  PMID: 21963266 BACKGROUND

• Clark TY, Clark RA. Atropine 0.01% Eyedrops Significantly Reduce the Progression of Childhood Myopia. J Ocul Pharmacol Ther. 2015 Nov;31(9):541-5. doi: 10.1089/jop.2015.0043. Epub 2015 Jul 28.

  PMID: 26218150 BACKGROUND

MeSH Terms

Conditions

Myopia; Photophobia

Interventions

Atropine

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Dr. Jeffrey Walline
• Organization: The Ohio State University College of Optometry

walline.1@osu.edu

(614) 247-6840

Study Officials

• Jeffrey Walline

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Dean For Research

Model Details: Subjects will take drops for one week and measurements will be taken before and after treatment period.

Study Record Dates

• First Submitted: June 27, 2018
• First Posted: July 19, 2018
• Study Start: July 23, 2018
• Primary Completion: January 17, 2019
• Study Completion: January 17, 2019
• Last Updated: December 2, 2022
• Results First Posted: December 2, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)