Effects of Stulln and Accommodative Training

NCT05107791 | Withdrawn Phase 1 FDA Drug

• 1 other identifier: Stulln-1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The present study tests the hypothesis that Stulln eyedrops improve accommodative functions by improving the short term facility of ciliary muscles that can be transferred into long-term adaptation. To test this, the investigators propose to conduct a prospective randomized control trials where participants with accommodative dysfunctions are randomly assigned to four groups: control, Stulln only and Stulln plus vision training. The investigators' theory predicts that the efficacy of Stulln will be augmented by vision training.

Conditions

Accommodation Disorder; Visual Fatigue

Outcome Measures

Primary Outcomes (4)

• Change in Accommodative amplitude

  The change in the diopter value of the closest distance at which the visual image con be kept clear between the baseline, 4-week, and 8-week assessments.

  Baseline, 4th and 8th week

• Chang in Accommodative Facility

  Change in the frequency of clearing the image with +/- 2D flipper in a minute between the baseline, 4-week, and 8-week assessments.

  Baseline, 4th and 8th week

• Change in Accommodative Endurance

  The change in the difference in the frequency of clearing the image in two consecutive minutes measured at the baseline, 4th week, and 8th week.

  Baseline, 4th, and 8th week

• Change in Visual Fatigue

  Change in the score measured from CISS questionnaire between the baseline, 4-week, and 8-week assessment.

  Baseline, 4th, and 8th week

Study Arms (2)

Stulln Eyedrops

EXPERIMENTAL

Augentropfen Stulln Mono Eye Drops (Stulln eyedrops) will be provided to participants in individual single-use vials. Participants will apply the drops to the two eyes 3 times a day, six days a week before sustained eye use (except Sunday).

Drug: Stulln Eyedrops

Theta Tears

SHAM COMPARATOR

Thera Tears (Sodium Carboxymethylcellulose 0.25%) will be provided to participants in individual single-use vials. Participants will apply the drops to the two eyes 3 times a day, six days a week before sustained eye use (except Sunday).

Drug: Thera Tears

Interventions

Stulln Eyedrops DRUG

Stulln eyedrops will be applied to the anterior surface of cornea 3 times a day, 6 days a week. Half of participants (46) also receive accommodative training during the second stage (month) of the study while the rest maintains the Stulln eyedrops intervention.

Also known as: Accommodative training

Stulln Eyedrops

Thera Tears DRUG

The eyedrops will be used in the identical manner as Stulln eyedrops.

Theta Tears

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Be between 18 and 45 years of age.
• Have normal/corrected-to-normal monocular acuity of better than 20/25 for both eyes.
• Have normal contrast sensitivity.
• Be a native English speakers or possess college-level English reading proficiency.
• Have a current optical prescription (obtained less than 2 years ago).
• Have accommodative dysfunctions, including reduced accommodative amplitude, range, facility and endurance.

You may not qualify if:

• Have no prismatic correction.
• No clinically significant ocular pathology (e.g., cataract, keratoconus, dry eye, diabetic retinopathy, or age-related macular degeneration) that would limit the effectiveness of vision training.
• Have no binocular dysfunction, including amblyopia, strabismus, and other binocular diseases that would impede accommodative training.

Sponsors & Collaborators

• Pacific University: lead

Study Sites (1)

Vision Performance Institute

Forest Grove, Oregon, 97116, United States

Location

MeSH Terms

Conditions

Asthenopia

Interventions

Carboxymethylcellulose Sodium

Condition Hierarchy (Ancestors)

Eye Diseases

Intervention Hierarchy (Ancestors)

Methylcellulose; Cellulose; Glucans; Polysaccharides; Carbohydrates

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Vision Performance Institute

Study Record Dates

• First Submitted: February 28, 2018
• First Posted: November 4, 2021
• Study Start: March 15, 2021
• Primary Completion: August 31, 2021
• Study Completion: August 31, 2021
• Last Updated: May 21, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)