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

NCT04525170 | Withdrawn

• 1 other identifier: CM-002-002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

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.

Conditions

Ametropia

Outcome Measures

Primary Outcomes (3)

• questionnaire addressing subjective comfort and wear time

  Subjects rated on a scale from 1 to 10, where 1 was 'poor' and 10 was 'excellent'.

  subjects will be followed-up for one month

• limbal redness - ocular biomicroscopy

  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.

  subjects will be followed-up for one month

• corneal staining - ocular biomicroscopy

  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.

  subjects will be followed-up for one month

Study Arms (2)

HPT treated

EXPERIMENTAL

daily wear Hexafocon A rigid contact lens treated with Hydra PEG surface coating

Device: HPT treatment

untreated

EXPERIMENTAL

daily wear Hexafocon A rigid contact lens

Device: untreated

Interventions

HPT treatment DEVICE

Also known as: Hydra-PEG (Polyethylene Glycol) Treatment

HPT treated

untreated DEVICE

untreated

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Contamac Ltd: lead

Study Sites (2)

Hartwig Research Center

Heikendorf, S-H, 24226, Germany

Location

Siehste

Kassel, Germany

Location

MeSH Terms

Conditions

Refractive Errors

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Eye Diseases

Study Officials

• Andreas Hartwig, PhD

  Hartwig Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2015
• First Posted: August 25, 2020
• Study Start: September 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: August 25, 2020

Record last verified: 2020-08

Locations

DE (2)