NCT01097577

Brief Summary

The purpose of this study is to compare the efficacy of pregabalin to placebo for postoperative pain control after photorefractive keratectomy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Mar 2010

Shorter than P25 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
10.4 years until next milestone

Results Posted

Study results publicly available

October 28, 2020

Completed
Last Updated

October 28, 2020

Status Verified

October 1, 2020

Enrollment Period

3 months

First QC Date

March 31, 2010

Results QC Date

August 17, 2020

Last Update Submit

October 3, 2020

Conditions

Postoperative Pain

Keywords

photorefractive keratectomyexcimer laserPRKpain, postoperativepregabalin

Outcome Measures

Primary Outcomes (1)

  • Clinical Efficacy

    Determine if clinical efficacy is achieved with pregabalin administered prior to PRK and continued for 5 days. This will be evaluated using the short-form McGill pain questionnaire (SF-MPQ). Primary efficacy is assessed on 100mm Visual Analog Scale (VAS); total range is 0 to 100. A score closer to zero indicates a better outcome of less pain.

    5 days

Secondary Outcomes (5)

  • PPI Score

    5 days

  • Total MPQ Score

    5 days

  • Quality of Life - BPI

    5 days

  • Clinical Efficacy 2

    5 days

  • Epithelial Healing Time

    5 days or more

Study Arms (2)

pregabalin

EXPERIMENTAL

Oral Pregabalin 75 mg capsule twice daily administered prior to PRK and continued for 5 days

Drug: pregabalin

Placebo

PLACEBO COMPARATOR

Oral placebo capsule (Lactose) twice daily administered prior to PRK and continued for 5 days

Drug: Placebo

Interventions

pregabalinDRUG

1 capsule (75 mg) by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.

Also known as: Lyrica
pregabalin
PlaceboDRUG

1 capsule by mouth twice daily starting two hours prior to surgery and continuing 4 days postoperatively.

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Healthy ocular status
  • Stable preoperative refractive anisometropia
  • Consented to the PRK surgical procedure

You may not qualify if:

  • Pregnant or breastfeeding
  • Diagnosed with autoimmune disease or diabetes
  • Patients with a known adverse reaction or hypersensitivity to gabapentin or pregabalin
  • Patients only desiring PRK on one eye
  • Patients with history of drug use/abuse/addiction
  • Patients who are on chronic pain medications
  • Patients currently taking anti-epileptic, antidepressant and/or anti-psychotic medications
  • Patients with a history of suicidality
  • Patients with chronic renal insufficiency (defined as estimated creatinine clearance less than 30ml/min or Scr ≥ 2.0) 10) Patients who have experienced angioedema, or have heart failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wilford Hall Medical Center - Refractive Surgery Center

Lackland Air Force Base, Texas, 78236, United States

Location

Related Publications (1)

  • Meek JM, Rosbolt MB, Taylor KR, Fusco EA, Panday VA, Reilly CD. Pregabalin versus placebo in postoperative pain relief of patients' status post photorefractive keratectomy: a double-masked, randomized, prospective study. J Ocul Pharmacol Ther. 2014 Sep;30(7):527-32. doi: 10.1089/jop.2013.0208. Epub 2014 Jun 10.

    PMID: 24914779RESULT

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Pregabalin

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

gamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsOrganic ChemicalsAmino AcidsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Julie Meek, Clinical Pharmacist
Organization
US Air Force
julie.m.meek.mil@mail.mil
210-808-2200

Study Officials

  • Julie M Meek, PharmD

    59th Medical Wing

    PRINCIPAL INVESTIGATOR

  • Charles Reilly, MD

    59th Medical Wing

    STUDY CHAIR

  • Margaret Bonnie Rosbolt, PharmD, CCRC

    59th Medical Wing

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Pharmacist

Study Record Dates

First Submitted

March 31, 2010

First Posted

April 1, 2010

Study Start

March 1, 2010

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

October 28, 2020

Results First Posted

October 28, 2020

Record last verified: 2020-10

Locations

US(1)