Efficacy of Scleral Contact Lenses for Daily Wear for Regular and Irregular Refractive Errors Compared to Habitually Worn Scleral Lenses

• Sponsor: Joseph Barr (Other)
• Overall Status: Completed
• CT.gov ID: NCT02643095
• Collaborator: (none)
• Enrollment: 22
• Arm: 1
• Actual Duration (Months): 7.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Scleral Lens Wearers	Device: scleral contact lens	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Actual Study Start Date: Jan 26, 2016
• Actual Primary Completion Date: Aug 8, 2016
• Actual Study Completion Date: Aug 31, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Lens fitting/evaluation 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; Scleral contact lens

Outcome Measures

Primary Outcome Measures

1. The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses [1 month after lens is dispensed]

   The primary endpoint of the study is the overall satisfaction and desire to continue wearing the study lenses as measured by a psychometric questionnaire at the completion of the study.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subjects may be male or female, of any race, and at least 18 years old at the time of the pre-treatment examination.

2. Subjects must habitually wear scleral contact lenses for an average wearing time of 6 hours per day.

3. 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).

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

5. 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).

Exclusion Criteria:

1. Female subjects who are pregnant, breast-feeding or intend to become pregnant over the course of the study.

2. 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.

1. Subjects with active ophthalmic disease or abnormality including glaucoma, chorioretinitis, central retinal artery or vein occlusion, intraocular or ocular infection.

2. Subjects who are participating in any other clinical trial (FDA or other)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Joseph Barr

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Joseph Barr, Professor Emeritus, Ohio State University
• ClinicalTrials.gov Identifier: NCT02643095
• Other Study ID Numbers: 2015W0197
• First Posted: Dec 30, 2015
• Last Update Posted: Sep 13, 2018
• Last Verified: Aug 1, 2018

Study Results

Participant Flow

Arm/Group Title	Lens Fitting/Evaluation
Arm/Group Description	This study was conducted with subjects who already habitually wore scleral contact lenses. The study lens was made with a material that is already widely available and has a new design. It was fit by the investigators and assessed one week and 1 month of wear. scleral contact lens: Scleral contact lens
Period Title: Overall Study
STARTED	22
COMPLETED	21
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Lens Fitting/Evaluation
Arm/Group Description	This study was conducted 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 was fit by the investigators and assessed and at one week and 1 month. scleral contact lens: Scleral contact lens
Overall Participants	22
Age, Customized (Count of Participants)
Age 18 or older	22 100%
Sex: Female, Male (Count of Participants)
Female	9 40.9%
Male	13 59.1%
Race and Ethnicity Not Collected (Count of Participants)

Outcome Measures

1. Primary Outcome

Title	The Primary Endpoint of the Study is the Overall Satisfaction and Desire to Continue Wearing the Study Lenses
Description	The primary endpoint of the study is the overall satisfaction and desire to continue wearing the study lenses as measured by a psychometric questionnaire at the completion of the study.
Time Frame	1 month after lens is dispensed

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Lens Fitting/Evaluation
Arm/Group Description	This study was conducted 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 was fit by the investigators and assessed and at one week and 1 month. scleral contact lens: Scleral contact lens
Measure Participants	21
Preferred test lenses to habitual lenses	15 68.2%
Preferred habitual lenses to test lenses	2 9.1%
No preference	4 18.2%

Adverse Events

Time Frame	Adverse event data was collected at all study visits, including a visit after 1 week and 1 month of lens wear.
Arm/Group Title	Lens Fitting/Evaluation
Arm/Group Description	This study was conducted 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 was fit by the investigators and assessed and at one week and 1 month. scleral contact lens: Scleral contact lens
All Cause Mortality
	Lens Fitting/Evaluation
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Serious Adverse Events
	Lens Fitting/Evaluation
	Affected / at Risk (%)	# Events
Total	0/21 (0%)
Other (Not Including Serious) Adverse Events
	Lens Fitting/Evaluation
	Affected / at Risk (%)	# Events
Total	1/21 (4.8%)
Eye disorders
punctate keratitis	1/21 (4.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.