Clinical Evaluation of HPT Treated Rigid Contact Lenses Made From Hexafocon A

• ClinicalTrials.gov Identifier: NCT04525170
• Recruitment Status: Withdrawn
• First Posted: August 25, 2020
• Last Update Posted: August 25, 2020
• Sponsor: Contamac Ltd
• Information provided by (Responsible Party): Contamac Ltd

Study Description

Brief Summary:

This will be an up to six months, subject-masked, contralateral, parallel-group, randomised, daily wear study. All subjects will wear the Test lens in one eye and the Control lens in the other eye. Data from the first four weeks of Test and Control lens exposure will be used for the FDA 510 (k) submission.

Condition or disease	Intervention/treatment	Phase
Ametropia	Device: HPT treatment; Device: untreated	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Clinical Evaluation of Hydra-PEG (Polyethylene Glycol) Treatment (HPT) Treated Rigid Contact Lenses Made From Hexafocon A
• Actual Study Start Date: September 2015
• Actual Primary Completion Date: December 2015
• Actual Study Completion Date: December 2015

Arms and Interventions

Arm	Intervention/treatment
Experimental: HPT treated; daily wear Hexafocon A rigid contact lens treated with Hydra PEG surface coating	Device: HPT treatment; Other Name: Hydra-PEG (Polyethylene Glycol) Treatment
Experimental: untreated; daily wear Hexafocon A rigid contact lens	Device: untreated

Outcome Measures

Primary Outcome Measures :

1. questionnaire addressing subjective comfort and wear time [ Time Frame: subjects will be followed-up for one month ]
   Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.
2. limbal redness - ocular biomicroscopy [ Time Frame: subjects will be followed-up for one month ]
   Findings were graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.
3. corneal staining - ocular biomicroscopy [ Time Frame: subjects will be followed-up for one month ]
   Findings were graded based on a grading scale which ranged from 0 to 4, where 0 is none, 1 is trace, 2 is mild, 3 is moderate and 4 is severe.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Willing and able to sign the informed consent form
• Aged ≥18 years old
• Experienced wearer of rigid gas permeable contact lenses
• Subject's habitual contact lenses must be made of Boston XO (hexafocon A) material
• Subjects must have owned spectacles or contact lenses prior to enrolment for this trial
• Spherical power between -10.00 D and +10.00 D (at vertex distance 0 mm)
• Corneal astigmatism ≤2.00 D

Exclusion Criteria:

• Eye injury or surgery within 3 months immediately prior to enrolment for this trial
• Pre-existing ocular irritation that would preclude contact lens fitting
• Currently enrolled in an ophthalmic clinical trial
• Evidence of systemic or ocular abnormality, infection or disease which is likely to affect successful wear of contact lenses or use of the accessory solutions, as determined by the investigator
• Any use of medications for which contact lens wear could be contradicted, as determined by the investigator
• Current extended-wear users (sleep-in overnight)
• Current monovision lens wearers
• Current wearers of multifocal contact lenses
• Current wearers of toric contact lenses (front surface design)
• Current wearers of astigmatic contact lenses (posterior surface design)
• Has a reported "Strong" comfort or vision preference between each eye with their habitual RGP lenses
• Unacceptable fit of habitual lenses
• Pregnant women and nursing mothers
• Best-corrected visual acuity worse than 6/9 (LogMAR: +0.20; Snellen decimal: 0.63)

Contacts and Locations

Locations

Germany

Hartwig Research Center

Heikendorf, S-H, Germany, 24226

Siehste

Kassel, Germany

Sponsors and Collaborators

Contamac Ltd

Investigators

• Principal Investigator: Andreas Hartwig, PhD; Hartwig Research Center

More Information

• Responsible Party: Contamac Ltd
• ClinicalTrials.gov Identifier: NCT04525170
• Other Study ID Numbers: CM-002-002
• First Posted: August 25, 2020
• Last Update Posted: August 25, 2020
• Last Verified: August 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Refractive Errors; Eye Diseases