Endothelial Bleb Response With Toric Lenses

NCT ID: NCT00630305

Last Updated: 2017-03-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2008-07-31

Brief Summary

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.

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.

Conditions

Ametropia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: OTHER

alphafilcon A toric

Intervention Type: DEVICE

Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).

senofilcon A toric

Intervention Type: DEVICE

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.

Group Type: OTHER

alphafilcon A toric

Intervention Type: DEVICE

Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).

senofilcon A toric

Intervention Type: DEVICE

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.

Group Type: OTHER

lotrafilcon B toric

Intervention Type: DEVICE

Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).

senofilcon A toric

Intervention Type: DEVICE

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.

Group Type: OTHER

lotrafilcon B toric

Intervention Type: DEVICE

Subjects that were randomized to receive lotrafilcon B toric during one of the four sessions (Sessions A, B, C and D).

senofilcon A toric

Intervention Type: DEVICE

Subjects that were randomized to receive senofilcon A toric during one of the four sessions (Sessions A, B, C and D).

Interventions

alphafilcon A toric

Subjects that were randomized to receive alphafilcon A toric during one of the four sessions (Sessions A, B, C and D).

Intervention Type: 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).

Intervention Type: 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).

Intervention Type: DEVICE

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Johnson & Johnson Vision Care, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Noel A Brennan, McOptom PhD

Role: PRINCIPAL_INVESTIGATOR

Brennan Consultants

Locations

Brennan Consultants 110 Auburn Rd

Auburn Village, Victoria, Australia

Countries

Australia

Other Identifiers

JJO0717

Identifier Type: -

Identifier Source: secondary_id

CR-0726

Identifier Type: -

Identifier Source: org_study_id