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Endothelial Bleb Response With Toric Lenses

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier:
NCT00630305
First received: February 28, 2008
Last updated: January 11, 2017
Last verified: January 2017
  Purpose
Evaluate the short-term corneal response of oxygen deprivation when using toric contact lenses. The response will be noted by endothelial bleb formation in both open eye and closed eye state.

Condition Intervention
Ametropia
Device: alphafilcon A toric
Device: lotrafilcon B toric
Device: senofilcon A toric

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
Official Title: Evaluation of the Short-Term Corneal Endothelial Response to Wear of Toric Soft Contact Lenses in Asian Eyes

Further study details as provided by Johnson & Johnson Vision Care, Inc.:

Primary Outcome Measures:
  • Endothelial Bleb Areas on Cornea: Session A- Open Eye [ Time Frame: 20 minutes post-lens insertion ]
    Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.

  • Endothelial Bleb Areas on Cornea: Session B- Closed Eye [ Time Frame: 20 minutes post-lens insertion ]
    Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.

  • Endothelial Bleb Areas on Cornea: Session C- Open Eye [ Time Frame: 20 minutes post-lens insertion ]
    Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.

  • Endothelial Bleb Areas on Cornea: Session D- Closed Eye [ Time Frame: 20 minutes post-lens insertion ]
    Mean area of endothelial blebs in the following corneal locations: Central, Nasal, Temporal, Inferior, Superior. A masked observer performed the analysis by subjectively selecting a region in a given image that provided an optimal balance of maximum area and clarity of cell outlines. Blebs were then outlined manually and the software calculated the area of blebs. The different sessions are reported showing results for each lens according to the lens worn in the contralateral (contra) eye.Open eye sessions simulated the subjects normal ocular behavior during waking hours; closed eye sessions simulated ocular activity during duration of closed eye activity, such as sleeping. Results are reported as the mean percent difference between the stated test (senofilcon A) and the control lens (alphafilcon A, lotrafilcon B), after 20 minutes of wear, for each testing scenario.


Enrollment: 37
Study Start Date: January 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Session A
Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session A only contains senofilcon A toric and alphafilcon A toric lenses.
Device: alphafilcon A toric
Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).
Device: senofilcon A toric
Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
Session B
Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session B only contains senofilcon A toric and alphafilcon A toric lenses.
Device: alphafilcon A toric
Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).
Device: senofilcon A toric
Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
Session C
Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session C only contains senofilcon A toric and lotrafilcon B toric lenses.
Device: lotrafilcon B toric
Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).
Device: senofilcon A toric
Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).
Session D
Subjects were first randomized to a session and then randomized to receive one of four lens sequences for that session. Each subject participated in all four sessions. Session D only contains senofilcon A toric and lotrafilcon B toric lenses.
Device: lotrafilcon B toric
Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).
Device: senofilcon A toric
Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).

Detailed Description:
Interested subjects who meet the entry criteria for the study will be scheduled for four sessions of approximately 30 minutes duration each. Informed consent obtained. Baseline measurements of visual acuity and corneal and conjunctival physiology will be recorded. An examination of the endothelium of the corneas will be conducted using the specular microscope, readings obtained at 5 locations on each cornea: one in the centre and one in each of the superior, inferior, nasal and temporal peripheral regions, approximately 2mm from the limbal margin. The assigned lenses will be inserted according to a fixed-allocation randomization schedule, where each session follows an optimized 2- period simultaneous crossover design, which specifies lenses to be used in each of the four sessions. Lenses will be worn for 20 minutes and then removed. Endothelial specular microscopy will be conducted at 20 minutes with the lenses on. A final evaluation of corneal and conjunctival physiology will be performed prior to subject clearance from the study.
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Successful soft contact lens wear in daily mode for a minimum of 1 month prior to start of the study without experiencing difficulties or contact lens related complications.
  2. At least 18 years of age and mentally competent to sign an informed consent form.
  3. Healthy eyes and no use of ocular medication.
  4. Similarity of optical parameters between eyes.
  5. Physical appearance typical of Asian eyes

Exclusion Criteria:

  1. A medical or ocular condition that may influence the outcome of this trial.
  2. Current use of ocular/systemic medication that may influence the outcome of this trial.
  3. Failure to wear soft lenses for 2 weeks prior to the start of the study.
  4. Current enrolment or participation in another clinical study.
  5. Current state of pregnancy or breastfeeding
  6. Anisometropia greater than 1.00D (equivalent sphere).
  7. Unequal acuities between eyes (greater than 1 line)
  8. Unequal corneal curvatures (>1.00D)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00630305

Locations
Australia, Victoria
Brennan Consultants 110 Auburn Rd
Auburn Village, Victoria, Australia, 3122
Sponsors and Collaborators
Johnson & Johnson Vision Care, Inc.
Investigators
Principal Investigator: Noel A Brennan, McOptom PhD Brennan Consultants
  More Information

Responsible Party: Johnson & Johnson Vision Care, Inc.
ClinicalTrials.gov Identifier: NCT00630305     History of Changes
Other Study ID Numbers: CR-0726
JJO0717
Study First Received: February 28, 2008
Results First Received: March 26, 2014
Last Updated: January 11, 2017

Keywords provided by Johnson & Johnson Vision Care, Inc.:
toric
endothelial bleb

Additional relevant MeSH terms:
Refractive Errors
Eye Diseases

ClinicalTrials.gov processed this record on May 22, 2017