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Cataract ExtractionPhase 1/2NCT00721695

Exploratory Study of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction by Phacoemulsification.

A Phase 1/2 study testing OMS302 and OMS302-PE in people with Cataract Extraction, run by Omeros Corporation at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is an exploratory study to determine the safety and clinical benefit of OMS302 Injection in subjects undergoing Cataract Extraction with Lens Replacement (CELR) using a coaxial phacoemulsification process. Read more about this study

Who is it for?
Ages 50 years and older
Conditions the study is for
Cataract Extraction
What is being tested?
OMS302 and OMS302-PE
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
4 sitesUnited States
Study dates
May 2008to Feb 2009
Phase
Phase 1/2
Are there results?
None posted in the registry

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

Who may be able to join

  • Subject is 50 years of age or older.
  • Subject is to undergo unilateral primary CELR for an age-related cataract under topical anesthesia and using a clear cornea incision.
  • Subject's history and physical examination are within normal limits or the examination is clinically non-significant for purposes of the study as determined by the Investigator, and subject is in good general health.
  • Subject has best corrected visual acuity (BCVA) of 20/400 or better in the non-study eye.
  • Subject has intraocular pressure (IOP) between 5 mmHg and 22 mmHg, inclusive, in the study eye.

Who cannot join

  • Subject is allergic to any of the individual ingredients in OMS302
  • Subject who is taking medications with the same activities as that of the active ingredients in OMS302 for defined time intervals prior to and after surgery.
  • Female subject of childbearing potential (i.e., not surgically sterilized nor post-menopausal longer than one year) who is not using an effective method of birth control within at least 14 days prior to surgery or has a positive pregnancy test.
  • Subject who has a present condition or history of any clinically significant uncontrolled gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, neurological, psychiatric, connective tissue, respiratory, or medical disorder as determined by the Investigator.
  • Subject who is taking anticoagulants.
  • Subject who is taking or needs to take for the duration of the study any of the prohibited medications.
Show all 17Show fewer
  • Subject with pseudo-capsular exfoliation, or evidence of prior iritis or of ocular trauma with iris damage, or who has used pilocarpine within six months of screening.
  • Subject that has uncontrolled chronic ocular disease.
  • Subject that has active corneal pathology or scarring noted in either eye (except superficial punctate keratopathy in the non-study eye).
  • Subject that has extraocular/intraocular inflammation in either eye.
  • Subject has an active bacterial and/or viral infection in either eye.
  • Subject that has narrow-angle glaucoma, unstable glaucoma, or glaucoma being treated with prostaglandins or prostaglandin analogues.
  • Subject taking, or has taken within the past year, an alpha adrenergic antagonist.
  • Subject that has participated in or is currently participating in any investigational drug or device trial within the previous 30 days prior to the day of surgery.
  • Subject that has had intraocular conventional surgery within the past three months or intraocular laser surgery within one month of the planned surgery in the study eye.
  • Subject that requires the use of other topical medications during the trial except prophylactic antibiotics, topical lid care or glaucoma medications or tear replacement solutions.
  • Subject that needs other ocular surgery at the time of the cataract extraction.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Chu Vision Institute

    Bloomington, Minnesota, 55420

  • Silverstein Eye Centers

    Kansas City, Missouri, 64133

  • Davis Duehr Dean

    Madison, Wisconsin, 53715

  • Shasta Eye Medical Group

    Redding, California, 96002

Other trials in United States

About this study

Official title: Randomized, Controlled, Double-Masked, Multicenter, Exploratory Study of the Clinical Benefit and Safety of OMS302 Injection in Subjects Undergoing Unilateral Cataract Extraction With Lens Replacement (CELR) Using a Coaxial Phacoemulsification Process

This is an exploratory study to determine the safety and clinical benefit of OMS302 Injection in subjects undergoing Cataract Extraction with Lens Replacement (CELR) using a coaxial phacoemulsification process.

Read the detailed description

OMS302 Injection is a mydriatic/anti-inflammatory combination investigational drug product being developed as an irrigation solution during intracameral lens replacement surgical procedures of the eye. OMS302 irrigation solution may induce and maintain an adequately dilated pupil and reduce postoperative symptoms of discomfort such as eye pain and irritation. The use of OMS302 irrigation solution may eliminate the need for pre-operative dilation of the eye and could reduce the postoperative use of an anti-inflammatory and pain medications following surgery.

Being tested
OMS302, OMS302-PE, Vehicle
Keywords
Cataract, Cataract Extraction, Lens Implantation, Phacoemulsification
Medical subject headings
Cataract

What participants receive

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

  • OMS302Drug

    Also called OMS302 Irrigation Solution

    OMS302 Irrigation Solution

  • OMS302-PEDrug

    Also called OMS302-PE HCI Irrigation Solution

    OMS302-PE HCI Irrigation Solution

  • VehicleDrug

    Also called Standard topical mydriatics and Balanced Salt Solution Irrigation Solution

    Standard topical mydriatics and Balanced Salt Solution Irrigation Solution

Study groups in NCT00721695
Study groupRoleWhat they receive
1ExperimentalOMS302 Irrigation Solution
Receives: Drug: OMS302
2Active comparatorOMS302-PE HCl Irrigation Solution
Receives: Drug: OMS302-PE
3Placebo comparatorStandard topical mydriatics and BSS Irrigation Solution
Receives: Drug: Vehicle

What is being measured

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

  1. Pupil diameter

    Measured: Day of Surgery

  2. Pain and other measures of ocular discomfort

    Measured: 14 days

  3. Degree of inflammation in the anterior chamber

    Measured: 14 days

Secondary outcomes (2)

  1. Ocular safety and changes in visual activity and intraocular pressure

    Measured: 28 days

  2. General measures of safety

    Measured: 28 days

Timeline

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

  1. First posted24 Jul 2008 (estimated)
  2. Study startMay 2008
  3. Primary completionFeb 2009
  4. Study completionFeb 2009

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
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00721695
Sponsor's protocol ID
C07-005
Status last verified
Jul 2014
First submitted
22 Jul 2008
Last updated
18 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • Behndig A, Eriksson A. Evaluation of surgical performance with intracameral mydriatics in phacoemulsification surgery. Acta Ophthalmol Scand. 2004 Apr;82(2):144-7. doi: 10.1111/j.1600-0420.2004.00241.x.

    PubMed 15043530

  • Lundberg B, Behndig A. Intracameral mydriatics in phacoemulsification cataract surgery. J Cataract Refract Surg. 2003 Dec;29(12):2366-71. doi: 10.1016/s0886-3350(03)00522-4.

    PubMed 14709298

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing OMS302 and OMS302-PE in people with Cataract Extraction, run by Omeros Corporation at 4 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 5 inclusion and 17 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: finished, as of the sponsor's last update on 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Pupil diameter (time frame: Day of Surgery). The study lists 3 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 NCT00721695, which also lists 2 linked publications.

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 18 Jul 2014.

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