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HyperopiaPhase 1/2NCT01893359

Safety and Efficacy of Corneal Collagen Cross-linking Following LASIK for Treatment of Hyperopia and Hyperopic Astigmatism

A Phase 1/2 study testing riboflavin ophthalmic solution, 0% dextran, UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA) and UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off) in people with Hyperopia and Hyperopic Astigmatism, run by Glaukos Corporation at 5 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The objectives of this study are to evaluate the safety and efficacy, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK followed by cross-linking performed with the KXL… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hyperopia, Hyperopic Astigmatism
What is being tested?
riboflavin ophthalmic solution, 0% dextran, UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA) and UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2 participants
Where
5 sitesUnited States
Study dates
Aug 2013to Apr 2016
Phase
Phase 1/2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Be at least 18 years of age, male or female, of any race;
  • 2. Provide written informed consent and sign a HIPAA form;
  • 3. Willingness and ability to follow all instructions and comply with the schedule for study visits;
  • 4. Undergoing bilateral LASIK for the correction of hyperopia or hyperopic astigmatism;
  • 5. Intended treatment > +2.0 diopters (D) to < +6.0 D of MRSE hyperopia or hyperopia with astigmatism, with up to +6.0 D of spherical component and up to 5.0 D of astigmatic component (all refractions measured at the spectacle plane);
  • 6. Bilateral physiologic hyperopia;
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  • 7. For females capable of becoming pregnant, agree to have urine pregnancy testing performed at visit 2 prior to treatment; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the visit 2 and continue to use the method for one month following the treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
  • 8. Best spectacle corrected visual acuity (BSCVA) of 70 letters or more on ETDRS chart;
  • 9. Difficulty maintaining uncorrected visual acuity (UCVA) of at least 70 letters on ETDRS chart as evidenced by need for constant contact lens or spectacle wear;
  • 10. Less than 0.75 D spherical equivalent difference between cycloplegic and manifest refractions;
  • 11. Stable refraction (a difference of 0.50 D or less in MRSE) for the last 12 months, objectively documented (by previous clinical records, prescriptions, etc.), exclusive of changes determined by the investigator to be due to unmasking latent hyperopia;
  • 12. Normal corneal topography, as judged by the investigator;
  • 13. Removal of contact lenses for the required period of time prior to the screening refraction:
  • Soft - 3 Days
  • Soft Toric - 2 Weeks
  • Rigid gas permeable - 2 Weeks
  • 14. Contact Lens Wearers Only: Must demonstrate a stable refraction (a difference of 0.50 D or less) as determined by MRSE on two consecutive exam dates performed at least 7 days apart. A contact lens wearer is defined as someone who has worn contact lenses in either eye in the last 30 days.

Who cannot join

  • 1. Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
  • 2. If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test at Visit 2 prior to treatment or during the course of the study;
  • 3. Eyes which are aphakic;
  • 4. Eyes which are pseudophakic and do not have a UV blocking lens implanted;
  • 5. Acute or chronic disease or illness that would increase the operative risk or confound the outcomes of the study (e.g., dry eyes, immuno- compromised, connective tissue disease, clinically significant atopic disease, diabetes, etc.);
  • 6. Systemic medications that may confound the outcome of the study or increase the risk to the subject, including but not limited to steroids, antimetabolites, etc.;
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  • 7. Ocular condition that may predispose the subject to future complications, for example:
  • History or evidence of active or inactive corneal disease (e.g., herpes simplex keratitis, herpes zoster keratitis, recurrent corneal erosion syndrome, corneal dystrophy, etc.);
  • Evidence of retinal vascular disease;
  • Keratoconus or keratoconus suspect;
  • Glaucoma or glaucoma suspect by exam findings and/or family history;
  • 8. Previous intraocular or corneal surgery including prior refractive surgery that might confound the outcome of the study or increase the risk to the subject;
  • 9. An increased risk for developing strabismus post-treatment;
  • 10. Subjects with nystagmus or any other condition that would prevent a steady gaze during treatment or other diagnostic tests;
  • 11. Taking supplements containing Vitamin C (ascorbic acid) within 1 week of the cross-linking treatment;
  • 12. Corneal thickness <470 microns as measured by Pentacam;
  • 13. The Investigator may exclude or discontinue any subject for any sound medical reason;
  • 14. The subject should not have participated in any investigational drug or device study within 30 days of screening or be concurrently enrolled in another investigational drug or device study.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

United States5 sites

  • See Clearly Vision

    McLean, Virginia, 22102

  • Gordon -Weiss-Schanzlin Vision Institute

    San Diego, California, 92122

  • Vance Thompson Vision

    Sioux Falls, South Dakota, 57108

  • Hersh Vision Group

    Teaneck, New Jersey, 07666

  • Ophthalmic Consultants of Boston

    Waltham, Massachusetts, 02451

Other trials in United States

About this study

Official title: A Multi-Center, Randomized, Controlled Evaluation of the Safety and Efficacy of LASIK With Cross-linking Performed With the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution) Compared to LASIK Alone for Hyperopia and Hyperopic Astigmatism

The objectives of this study are to evaluate the safety and efficacy, with regards to regression of refractive outcome, as measured by manifest refraction spherical equivalent (MRSE), of two treatment regimens for hyperopic and hyperopic astigmatic subjects: LASIK followed by cross-linking performed with the KXL System and Photrexa ZD™ (Riboflavin Ophthalmic Solution), as compared to LASIK alone.

Being tested
riboflavin ophthalmic solution, 0% dextran, UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA), UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off), Laser-assisted in situ keratomileusis
Keywords
hyperopia, hyperopic astigmatism, cross-linking
Medical subject headings
Hyperopia, Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • riboflavin ophthalmic solution, 0% dextranDrug

    Also called Photrexa ZD

  • UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA)Device

    Also called KXL System

  • UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off)Device

    Also called KXL System

  • Laser-assisted in situ keratomileusisProcedure or surgery

    Also called LASIK

Study groups in NCT01893359
Study groupRoleWhat they receive
LASIK followed by Cross-linking (Continuous Wave)ExperimentalFollowing LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 2 minutes continuous UVA.
Receives: Drug: riboflavin ophthalmic solution, 0% dextran; Device: UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA); Procedure: Laser-assisted in situ keratomileusis
LASIK followed by Cross-linking (Pulsed)ExperimentalFollowing LASIK, the corneal bed will be thoroughly coated with five drops of riboflavin ophthalmic solution, rinsed with saline solution, and the corneal flap repositioned. The eye will then be irradiated at 30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off.
Receives: Drug: riboflavin ophthalmic solution, 0% dextran; Device: UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off); Procedure: Laser-assisted in situ keratomileusis
LASIK OnlyPlacebo comparatorEyes assigned to this arm will receive standard LASIK with no cross-linking.
Receives: Procedure: Laser-assisted in situ keratomileusis

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MRSE Regression

    The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.

    Measured: one week to six months

  2. MRSE Regression

    The co-primary efficacy endpoints are a comparison of MRSE regression in the refractive outcome between the LASIK only eyes and the LASIK with cross-linking eyes within each treatment type and duration (2 minutes continuous UVA or 3 minutes pulsed UVA cross-linking) expressed as the change between one week and six months, and one week and twelve months.

    Measured: one week to twelve months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jul 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionFeb 2015
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01893359
Sponsor's protocol ID
KXL-004
Status last verified
Apr 2021
First submitted
28 Jun 2013
Last updated
26 Apr 2021
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing riboflavin ophthalmic solution, 0% dextran, UVA Irradiation (30 mW/cm2 for 2 minutes continuous UVA) and UVA Irradiation (30 mW/cm2 for 3 minutes pulsed UVA with an on/off cycle of 2 seconds UVA on/1 second UVA off) in people with Hyperopia and Hyperopic Astigmatism, run by Glaukos Corporation at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MRSE Regression (time frame: one week to six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01893359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.

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