NCT02643095

Completed

Efficacy of Scleral Contact Lenses for Daily Wear for Regula...

Jennifer Fogt Source

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Other study identifiers

Sponsor study identifier

2015W0197

Study Type

interventional

Actual enrollment (reported)

22

Locations

0 countries

Sites

N/A

Timeline

Study Start

January 26, 2016

Actual (reported)

Primary Completion

August 8, 2016

Actual (reported)

Study Completion

August 31, 2016

Actual (reported)

Brief Summary

This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 22 participants
Study completion date: August 31, 2016
Actual (reported)
Listed locations: 0 countries · 0 sites

Trial Relationships

Click on a node to explore related trials.

Some registry-reported names shown below are not yet linked in this graph.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
December 28, 2015
Actual (reported)
First Posted
December 30, 2015
Actual (reported)
Study Start
January 26, 2016
Actual (reported)
Primary Completion
August 8, 2016
Actual (reported)
Study Completion
August 31, 2016
Actual (reported)
Results Posted
September 13, 2018
Actual (reported)

Last Updated: December 6, 2023
Status Verified: November 2023
Results QC Date: August 17, 2018
Last Update Submitted: November 13, 2023

Conditions

Scleral Lens Wearers

Outcome Measures

Primary Outcomes (1)

The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses
Number of Participants with Overall Satisfaction and Desire to Continue Wearing the Study Lenses
1 month after lens is dispensed

Study Arms (1)

Lens fitting/evaluation

EXPERIMENTAL

This study will be done with subjects who already habitually wear scleral contact lenses. The study lens is made with a material that is already widely available and has a new design. It will be fit by the investigators and will be assessed and at one week and 1 month.

Device: scleral contact lens

Interventions

scleral contact lensDevice

Scleral contact lens

Lens fitting/evaluation

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.
Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day.

Sponsors & Collaborators

Jennifer Fogt
Otherlead

Results Point of Contact

Title: Jennifer Fogt
Organization: The Ohio State University College of Optometry

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

22 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: NA
Masking: NONE
Purpose: OTHER
Intervention Model: SINGLE GROUP
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Assistant Professor

Study Record Dates

First Submitted

December 28, 2015

First Posted

December 30, 2015

Study Start

January 26, 2016

Actual (reported)

The prospective eye(s) must have refractive hyperopia or myopia from +20.00 to -20.00 diopters sphere (spectacle plane), with up to -10.00 diopters of refractive astigmatism (spectacle plane), as determined by manifest refraction (phoropter or trial frame with a 12.5 mm vertex distance).

Subjects must have best spectacle corrected visual acuity of at least 0.5 logMAR in each eye.

Subjects must be willing and capable to return for all scheduled follow-up visits for a period of at least 3 months (minimum of 1 month from initial dispensing).

You may not qualify if:

Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.
Subjects with a history of any of the following medical conditions: collagen vascular disease, autoimmune disease, immunodeficiency diseases, ocular herpes zoster or simplex, endocrine disorders (including, but not limited to active thyroid disorders and diabetes), lupus, and rheumatoid arthritis.
Note: The presence of diabetes (either type 1 or 2), regardless of disease duration, severity or control, will specifically exclude subjects from eligibility.
Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.
Subjects who are participating in any other clinical trial (FDA or other)

Contact the study team to confirm eligibility.

Primary Completion

August 8, 2016

Actual (reported)

Study Completion

August 31, 2016

Actual (reported)

Last Updated

December 6, 2023

Results First Posted

September 13, 2018

Record last verified: 2023-11

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02643095
Data provider: ClinicalTrials.gov
Source updated: 2023-12-06
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:19:52 UTC

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (1)

Lens fitting/evaluation

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Results Point of Contact

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record